PDA Environmental Monitoring Task Force
Jeanne E. Moldenhauer, Chairperson, Vectech Pharmaceutical Consultants, Inc. Aijaz Ahmad, Genentech, Inc.
Susan E. Arrigoni, Ortho-Clinical Diagnostics
Anthony M. Cundell, Ph.D., Wyeth-Ayerst Pharmaceuticals
Gary E. Strayer, Merck & Company, Inc.
John H. Ducote, Chiron Corporation
Susan F. Elder, Glaxo Wellcome, Inc.
Mary Beth Grace, Genentech, Inc.
David A. Ness, Abbott Laboratories, Inc.
Thaddeus G. Pullano, Ph.D., Wyeth-Lederle Vaccines and Pediatrics
James F. Quebbeman, Parke-Davis & Company
Berit Reinmüller, Royal Institute of Technology
Miriam Rozo, Ortho-Clinical Diagnostics
Lydia Troutman, Schering-Plough Corporation
Technical Reviewers
Russell E. Madsen, PDA
Robert Mello, RJM Pharmaceutical Consultants
Kenneth H. Muhvich, Ph.D., The Validation Group
Glenn Wright, Eli Lilly & Company
Acknowledgements
Franco De Vecchi, VPCI, for providing information relating to HVAC systems and environmental monitoring.
Anne Marie Dixon, Clean Room Management Associates, Inc., for providing the ISO information required for this document.
Phyllis Karpiel, Fujisawa Healthcare, Inc., for providing the majority of the typ-ing support.
Steve Yentes, Pfizer, Inc., for providing technical review of the document.
Elizabeth Joyce, Jordan Pharmaceuticals, Inc., for providing technical writing review of the document.
Fundamentals of
an Environmental
Monitoring Program
Technical Report No. 13
Revised
PDA
September/October 2001
Vol. 55, No. 5, September/October 2001, Supplement TR13, Revised i
PDA TECHNICAL REPORT NO. 13
REVISED
FUNDAMENTALS OF AN ENVIRONMENTAL
MONITORING PROGRAM
Table of Contents
1.0INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2.0ENVIRONMENTAL CLASSIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
3.0SURVEILLANCE SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.1Cleaning and Sanitization/Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.2Sample Site Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.3Sampling Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.4Alert and Action Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.5Data Management (Data Collection, Analysis, Approach, and Interpretation) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.5.1Data Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.5.2Data Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.5.3Data Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3.5.4Data Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.6Characterization of Isolates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.7Investigations/Corrective Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.8Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.0SYSTEM SURVEILLANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
4.1Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
4.1.1Terminal Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
4.1.2Aseptic Filling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
4.1.3Isolation Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
4.2Water Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
4.3Compressed Gas Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.4Air Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.4.1Non-Viable Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4.4.2Viable Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4.4.3Surface Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
4.5Personnel Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.5.1Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.5.2Training/Certification of Personnel for Aseptic Manufacturing Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.5.3Retraining . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.6Product or Component Bioburden . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.6.1Determination of Product or Component Bioburden . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.6.2Parametric Release and Bioburden . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.6.3In-Process Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.7Environmental Monitoring During Routine Sterility Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5.0VALIDATION/QUALIFICATION OF ENVIRONMENTAL MONITORING SYSTEMS . . . . . . . . . . . . . . . . . . . . . . . 25
5.1Environment/HV AC Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5.2Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
5.3Validation of Aseptic Processes – Media Fills (Process Simulation Tests) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Vol. 55, No. 5, September/October 2001, Supplement TR13, Revised iii
6.0CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
7.0BIBLIOGRAPHY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
8.0APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
APPENDIX A - Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 APPENDIX B - Equipment Manufacturers and Suppliers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 APPENDIX C - Examples of Current Typical Environmental Monitoring
Frequencies and Levels - Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 iv PDA Journal of Pharmaceutical Science and Technology
1.0 INTRODUCTION
The purpose of this document is to identify microbio-logical and particulate control concepts and principles as they relate to the manufacture of sterile pharmaceu-tical products. It expands substantially upon the first edition of Technical Report No. 13, Fundamentals of a Microbiological Environmental Monitoring Program, published by PDA in 1990. While this publication can-not possibly supplant the wealth of information pub-lished on this subject, it provides summary informa-tion and appropriate references for the reader to con-sult, if necessary. The objective was to contemporize the first edition through the utilization of current defi-nitions, recognition of improved environmental moni-toring procedures, and equipment.
This document should be considered as guidance; it is not intended to establish any mandatory or im-plied standard.
The task force consisted of members representing glo-bal companies, to ensure that the methods, terminol-ogy, and practices reflect the procedures utilized glo-bally. Technical reviews were performed by some of the more prominent environmental monitoring scien-tists in the world today.
This document serves as a source on clean room envi-ronmental test methods, and although some non-viable particulate and endotoxin testing data are included, its primary focus is microbiological control. The concepts for sterile product manufacturing are the most stringent application, but these concepts can also be applied to non-sterile product manufacture. The focus is environ-mental monitoring as it relates to facility control and compliance. This document was compiled to aid in set-ting up a program that is meaningful, manageable, and defendable.In order to ensure a consistently acceptable production environment, a comprehensive environmental control program should be supported by: (a) sound facility de-sign and maintenance, (b) documentation systems, (c) validated/qualified sanitization/disinfection procedures, (d) reliable process controls, (e) good housekeeping practices, (f) effective area access controls, (g) effec-tive training, certification/qualification and evaluation programs and (h) quality assurance of materials and equipment.
Environmental surveillance is a tool utilized to evalu-ate the effect of controls on the manufacturing envi-ronment. A process to assess the clean room and other controlled environments of a pharmaceutical facility can serve as an adjunct to the sterility assurance program for the microbial quality of drugs. The items addressed in this document include definitions, standards, surveil-lance support systems, system surveillance, validation systems, appendices of definitions and typical frequen-cies and levels, and a bibliography.
2.0ENVIRONMENTAL CLASSIFICATIONS The environmental monitoring program should be de-signed and implemented based on sound scientific prin-ciples, the need for and the utility of the collected data, and in conformance with the regulatory requirements of the government agencies regulating the manufactur-ing site. Personnel administering environmental moni-toring programs should be familiar with a variety of regulatory schemes if they are to be successful in serv-ing the United States and International product mar-kets. Efforts at harmonization are underway, and it is possible that many of the differences in the requirements for monitoring programs may disappear as the coun-tries and organizations involved come to some agree-ment on the overall approach to be taken. Therefore, it is important to keep up to date on the requirements for the different countries in which the product will be sold.
Vol. 55, No. 5, September/October 2001, Supplement TR13, Revised 1
This will ensure that the established program meets the monitoring requirements of each country. If the intent is to serve both the United States and the International markets, the most stringent requirements should be evaluated as the basis of an environmental monitoring program.
This section compares published environmental classi-fications for environmental monitoring in the United States and the European Union. Although these publi-cations are similar in many respects, there are impor-tant differences among them in terms of the informa-tion each provides.
Federal Standard 209E establishes airborne particulate cleanliness classes categorized as Class M 1 through M 7 (SI names). All of the classifications can be ap-plied to particles ≥ 0.5 μm, while other particle sizes, e.g., 0.1, 0.2, 0.3 and 5 μm, utilize only some of the classifications. In the United States, the pharmaceuti-cal industry classifies production areas as Class 100, 10,000 and 100,000 (M 3.5, M 5.5 and M 6.5, respec-tively) based on particles ≥ 0.5 μm, the classification reflecting the number of particles per cubic foot. It should be noted that the Institute for Environmental Sciences and Technology (IEST) has recommended that Federal Standard 209E be retired by the end of 2001 as a result of the publication of the ISO 14644-1 and 14644-2 documents.
FDA’s 1987 “Guideline on Sterile Drug Products Pro-duced by Aseptic Processing” discusses environmental requirements for critical areas (Class 100), in which sterile drugs are exposed to the environment. This docu-ment also includes specifications for viable airborne monitoring for Class 10,000 and Class 100,000 areas. Viable and non-viable guidance is https://www.wendangku.net/doc/295832362.html,P general information chapter <1116> “Microbial Evaluation and Classification of Clean Rooms and Other Controlled Environments” proposes limits for clean room levels, including air, surfaces, and personnel work-ing within the clean area. The chapter includes three classifications that would supplement the current cat-egories based on non-viable particulate limits.
In the European Union, The Rules Governing Medici-nal Products in the European Union, (Vol. IV: Good manufacturing practice for medicinal products) include an air classification system in Annex 1 under the head-ing “Manufacture of Sterile Medicinal Products.” Air quality is classified alphabetically as Grade(s) A through D, with Grade A being the cleanest. Associated with each respective grade is the maximum allowable num-ber of particles per cubic meter.
In addition to these publications, additional guidance is available through the International Organization for Standardization (ISO) which is a world-wide federa-tion of national standard bodies. The work of prepar-ing international standards is normally carried out through ISO technical committees. ISO/TC 198 pro-vides Guidance for Sterilization of Health Care Prod-ucts and ISO/TC 209 provides Guidance for the Clas-sification of Airborne Particulate for Clean Rooms and Associated Controlled Environments. Copies of these documents can be obtained from American National Standards Institute (ANSI).
It should be noted that all classifications have a direct counterpart in the documents prepared by other inter-national groups. Tables 1 through 3 summarize and com-pare these specifications.
2 PDA Journal of Pharmaceutical Science and Technology
Vol. 55, No. 5, September/October 2001, Supplement TR13, Revised 3T a b l e 1: C l a s s 100 M o n i t o r i n g T a b l e (M a x . v a l u e s a r e g i v e n ).
?P = D i f f e r e n t i a l p r e s s u r e *C o n t a c t p l a t e a r e a s v a r y f r o m 24–30 c m 2C o m m e n t : F e d -S t d -209E i n d i c a t e s t h a t S I n a m e s a n d u n i t s a r e p r e f e r r e d f o r n a m i n g a n d d e s c r i b i n g t h e c l a s s e s , b u t t h a t E n g l i s h (U .S . c u s t o m a r y ) u n i t s m a y b e u s e d . W i t h t h e
p u b l i c a t i o n o f I S O 14644-1 a n d 14644-2, i t i s e x p e c t e d t h a t F e d -S t d -209E w i l l b e r e t i r e d b y t h e e n d o f 2001.G r a d e A T e r m i n a l l y s t e r i l i s e d : F i l l i n g o f t e r m i n a l l y s t e r i l i s e d p r o d u c t s , w h e n u n u s u a l l y a t r i s k .A s e p t i c a l l y p r e p a r e d : A s e p t i c p r e p a r a t i o n a n d f i l l i n g . H a n d l i n g o f s t e r i l e s t a r t i n g m a t e r i a l a n d c o m p o n e n t s . T r a n s f e r o f p a r t i a l l y c l o s e d c o n t a i n e r s i n o p e n t r a y s .
G r a d e B B a c k g r o u n d f o r g r a d e A . T r a n s f e r o f p a r t i a l l y c l o s e d c o n t a i n e r s i n s e a l e d t r a y s .
4 PDA Journal of Pharmaceutical Science and Technology T a b l e 2: C l a s s 10,000 M o n i t o r i n g T a b l e (M a x . v a l u e s a r e g i v e n ).
?P = D i f f e r e n t i a l p r e s s u r e *C o n t a c t p l a t e a r e a s v a r y f r o m 24–30 c m 2C o m m e n t : F e d -S t d -209E i n d i c a t e s t h a t S I n a m e s a n d u n i t s a r e p r e f e r r e d f o r n a m i n g a n d d e s c r i b i n g t h e c l a s s e s , b u t t h a t E n g l i s h (U .S . c u s t o m a r y ) u n i t s m a y b e u s e d . W i t h t h e
p u b l i c a t i o n o f I S O 14644-1 a n d 14644-2, i t i s e x p e c t e d t h a t F e d -S t d -209E w i l l b e r e t i r e d b y t h e e n d o f 2001.G r a d e C T e r m i n a l l y s t e r i l i s e d : P r e p a r a t i o n o f s o l u t i o n s , w h e n u n u s u a l l y a t r i s k . F i l l i n g o f p r o d u c t s .A s e p t i c a l l y p r e p a r e d : P r e p a r a t i o n o f s o l u t i o n s t o b e s t e r i l e f i l t e r e d .
1
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Vol. 55, No. 5, September/October 2001, Supplement TR13, Revised 5
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3.0SURVEILLANCE SUPPORT
The data should be collected in a manner that is in con-formance with Current Good Manufacturing Practices (CGMP). CGMP states that the personnel supervising the environmental monitoring program should be com-petent in the scientific discipline and have appropriate training and authority. Equipment used should be cali-brated, systems should be appropriately validated, me-dia should be properly prepared, and all operational procedures should be written and followed.
Procedures should include appropriate controls to sup-port their use. Cleaning, sanitization/disinfection, site selection, and frequency of testing are key components to a good environmental monitoring program. Alert and action levels should be based on individual sample sites, but one may also choose to specify alert level and ac-tion levels based on the number of excursions in one area/system for one sampling period. Establishment of appropriate alert and/or action levels and a system for monitoring implies that data obtained are subject to continual review and that alert and action decisions are made by designated, authorized personnel qualified to make such decisions. To effectively execute microbio-logical surveillance support systems, there should be a documented system in place for identifying excursions; in addition, there should be a feedback mechanism for verification of any action taken in response to data. All data should be documented and trended.
3.1Cleaning and Sanitization/Disinfection
Implementation of cleaning and sanitization procedures is a critical component of overall facility control. Envi-ronmental monitoring data are used in determining the effectiveness of these procedures. It is common knowl-edge that the ideal sanitizer does not exist. Sanitizers that are effective against vegetative cells may be inef-fective against spores. Sanitizers or disinfectants that are effective against spores are usually corrosive to equipment (e.g., acidified bleach on stainless steel) and should be used sparingly on an as-needed basis. Selec-tion of sanitizers may include evaluation of required contact time, type of microorganisms that are to be eliminated, confirmation of efficacy, type of surface to be treated, toxicity, residue, and means of application. Validation of established cleaning and sanitization pro-cedures should demonstrate microbial reduction. The procedures also ensure the effectiveness of removal of product and detergent residue. The goal is to demon-strate that routine sanitization procedures, performed by trained cleaning personnel, consistently result in a level of microbial control suitable for the intended use of the area. Sanitization procedures are verified for the effectiveness of microbial reduction. It is a sound prac-tice to perform challenge testing of the selected sanitizers/disinfectants with isolates routinely recovered by the environmental monitoring program. This estab-lishes the practical effectiveness of the disinfectants.
3.2Sample Site Selection
Suitable sample sites vary widely depending on the clean room design and manufacturing process. Each process should be carefully evaluated when selecting sampling sites. The primary purpose of sampling should be to provide meaningful interpretable data that can help identify actual or potential contamination problems as-sociated with specific procedures, equipment, materi-als, and processes. One should be able to sample those sites most likely to result in product contamination if they become contaminated; however, it may be prudent to identify indicator sites that are near, but not in con-tact with product.
Factors to consider in selecting sites for routine surveillance are:
1.At which sites would microbial contamination most
likely have an adverse effect on product quality?
2.What sites would most likely demonstrate heaviest
microbial proliferation during actual production?
3.Should site selection involve a statistical design (e.g.,
following the calculations in Federal Standard 209E) or should site selection be made on the basis of grid profiling? Should some sites for routine monitoring be rotated?
4.What sites would represent the most inaccessible or
difficult areas to clean, sanitize, or disinfect?
5.What activities in the area contribute to the spread
of contamination?
6.Would the act of sampling at a given site disturb the
environment sufficiently to cause erroneous data to be collected or contaminate product? Should sam-pling only be performed at the end of the shift?
6 PDA Journal of Pharmaceutical Science and Technology
Note: There are some considerations applicable to
specific types of monitoring; they are described in
the individual monitoring sections of this document.
To establish routine sample sites, action and alert lev-
els, and testing frequency, one should take into consid-
eration the extent of contact or exposure that each ele-
ment of the manufacturing environment has with the
product. Sites having greater opportunity for contrib-
uting bioburden to the product should be sampled and
monitored. Product contact sources may include
compressed gases, room air, manufacturing equip-
ment, tools, critical surfaces, storage containers,
conveyors, gloved hands of personnel, and water.
Examples of non-product contact sources may in-
clude walls, floors, ceilings, doors, benches, chairs,
test instruments, and pass-throughs.
It must be recognized, however, that it may not always
be practical to select a site at the most critical location.
One should consider whether critical site monitoring
would actually increase probability of product contami-
nation. Additionally, critical sites may not be monitored
if there is a low probability of contamination during
processing (e.g., sterilized components which are not
manipulated).
Examples of sampling sites.
As pointed out in other sections of this document, there are many considerations in establishing an appropriate site for sampling (e.g., facility design, line configura-tions, validation data, process, historical data, test meth-odology, etc.). The sites listed in this section may or may not be applicable to a particular manufacturing process; factors pertaining to site selection are likely to be unique to individual facilities.3.3Sampling Frequency Monitoring requirements may vary widely in the indus-try depending on several factors including, but not lim-ited to, type of manufacturing process or product, fa-cility/process design, amount of human intervention,use of subsequent terminal sterilization (including ste-rility test release versus parametric release), and his-torical profiles of the microbiological environmental data. No single sampling scheme is appropriate for all environments. In addition, changes in sampling fre-quency, whether temporary or permanent, may be re-quired based on changes in practices, compendial require-ments, development of significant microbiological trends,acquisition of new equipment, or nearby construction of rooms or utilities. The key is to select monitoring frequen-cies that can identify potential system deficiencies.Vol. 55, No. 5, September/October 2001, Supplement TR13, Revised 7
The test frequency per site may be less frequent than the system or area frequency (e.g., one may choose to rotate sample sites). Test frequencies for batch-related, in-process monitoring may differ from those for rou-tine area monitoring. In many cases, monitoring per-formed in conjunction with batch production may ful-fill the requirements for routine area monitoring.
Prior to implementing any reduction in frequency, a summary of historical data, along with current and pro-posed sampling frequencies, should be reviewed and approved by the appropriate Quality Assurance person-nel. After reduction, data should be reviewed periodi-cally to determine if the reduced sampling frequency is still appropriate.
3.4Alert and Action Levels
Environmental monitoring programs may have action levels established based on applicable guidelines and review of historical data. They frequently recommend that alert levels also be established. Some companies also choose to set levels for individual clean rooms or sample sites. Typically, the action levels will be driven by the regulatory or industry guidelines while the alert levels may be driven by historical analysis of the envi-ronmental monitoring data. The application of alert and/ or action levels should follow written procedures and be employed in a consistent, non-arbitrary manner. To create consistency in treatment of alert and/or action levels, logical investigatory and/or corrective action steps should be pre-specified. Records should show that any excursion was recognized and that appropriate fol-low-up occurred.
Once alert and/or action levels have been established, they should be periodically reviewed as part of routine trend analysis. They may also be revised to reflect im-provements, advances in technology, changes in use patterns, or other changes.When no regulatory or industry guidelines are provided, alert and/or action levels may be derived statistically from historical data. An occasional excursion from these levels is to be expected at frequencies characteristic for the specific mathematical model utilized in their deri-vation. In some situations, only one level may be em-ployed, with any excursions triggering action. In other instances, a level may be used with a single excursion eliciting an alert/action level response and multiple or sequential deviations requiring action.
These levels are conservative measures designed to sig-nal potential or actual drift from historical or design performance characteristics. They are not extensions of product specifications, but are intended to flag changes so that corrective action may be taken before product quality is adversely affected. Not all situations require use of both alert and action levels.
Since there is no consensus as to the best mechanism to use for setting these levels, the following are approaches that have been used successfully within the pharma-ceutical industry. Where compendial requirements exist, they supersede the methods used in the fol-lowing examples.
a.Cut-off Value Approach
All the test data for a particular site are arranged in a histogram and the alert and action levels are set at values whose monitoring results are respectively 1% and 5% higher than the level selected. Other percen-tiles may be used in establishing levels. A variation is to take the last 100 monitoring results and use the 95th and 99th percentile values as the alert and ac-tion levels.
b.Normal Distribution Approach
This approach is best used for high counts only (a Poisson distribution is used for low counts). The mean and standard deviation of the data are calculated and
8 PDA Journal of Pharmaceutical Science and Technology
the alert and action levels are set at the mean plus two and three times the standard deviation, respectively. c.Non-parametric Tolerance Limits Approach
In this approach, alert and action limits are set using non-parametric (distribution free) methods. This is valuable for environmental monitoring data that typi-cally is not normally distributed, i.e., exhibits high levels of skewness towards zero counts. For the alert limit, the tolerance limit was set at a level of γ = 0.95 and P = 0.95. The action limit resulted from a toler-ance limit set at γ =0.95 and P = 0.99. These limits allow us to assert with confidence at least 95% that 100(P) or 99% of a population lies below the value, depicted by the stated limits for the respective data. For a discussion of this non-parametric procedure, see “Practical Nonparametric Statistics,” 3rd edition, by W. J. Conover, page 150.
Other models based on negative binomial, Poisson, Weibull, or exponential distributions are possible. It may be appropriate to determine the model that best fits the data and use that model to set the levels. Typically, con-tamination in strictly controlled environments does not fall within a normal distribution. Environmental moni-toring data may be evaluated to determine the suitabil-ity of the approaches to level setting.
3.5Data Management (Data Collection, Analysis,
Approach, and Interpretation)
Routine review and analysis of environmental monitor-ing data is essential to aid in the interpretation of pro-cess stability and assess overall control performance. Management should be kept abreast of trends and the subsequent state of operations within their facilities. Based on the large number of samples tested by a given facility, a computer-based data tracking system is rec-ommended. Prior to implementation, all database ap-plications used should be validated/qualified for spe-cific software applications.
3.5.1Data Collection
Routine data may be pooled into a designated database in a consistent record format. The record format should include (at a minimum): monitoring date, specific sam-pling locations, sampling methods, colony forming units (CFU) or non-viable count results, identification per-formed, product lot information, and current action level. A manual data entry or image scanner system with advantages of speed and accuracy can be used to populate tables. Data integrity must be verified prior to analysis.
3.5.2Data Analysis
Trends are often difficult to obtain and recognize, given the low colony forming unit (CFU) result usually ob-tained with viable environmental monitoring data. His-tograms, defined as pictorial graphs characterized by a number of data points that fall within a common fre-quency, are a valuable tool. Different room classifica-tions with definite requirements will produce different histograms. The CFU spread obtained across a Class 100,000 data set will not be observed in a data set from a Class 100 area. Therefore, each area (or area type) and accompanying data set must be viewed as distinct. A mathematical model could be applied not only with the objective in mind, but also the type of data to be analyzed. Moreover, data collected in Class 10,000 or 100,000 areas tend to assume distributions. A Class 10,000 fa-cility may lend itself to an exponential distribution where the majority of data points can be observed be-low the mean and thus appear not normally distributed; and a class 100,000 or non-classified area often dem-onstrates greater variability around the mean with a normal distribution. A Class 100 area distribution may be less obvious where an unsystematic approach, al-though less powerful, may work best.
Vol. 55, No. 5, September/October 2001, Supplement TR13, Revised 9
The following table provides some examples of differ-ent analysis objectives and the associated descriptions of what the analysis may include.
3.5.3Data Approach
The following approach describes a generalized method for data to assess the environmental control:
a.Determine objective of analysis (e.g., site location
alert/action, action level review, management up-date).
b.Specify data set to be analyzed.
c.Apply data plots such as histograms or pictorial
plots to access the basic data and to determine the nature of the distribution, if any. Such data plots can also be used to locate peculiarities such as out-liers or patterns.
d.Observe the distribution and proceed with the ap-
propriate mathematical model that best fits the over-all objective. If data conform to a specific distribu-tion, a parametric mathematical model may be ap-plied. If the data are not consistent with a particu-
lar distribution, then a non-parametric approach may be applicable.
e.Typically, an action level at the 99th percentile is employed. Consistent with the action level at the 99th percentile are the following mathematical models. Models can only be applied if the charac-ter of the data assumes a definite distribution. Action level estimate for a data set reflecting
an exponential or non-normal distribution
= 4.6 x (mean CFU)
Action level estimate for a data set reflecting
a normal distribution = 2.33 σ + (mean CFU) Note:When the action level is determined at the 99th percentile, an occasional excursion is
expected due to the model applied.
f.Regardless of the statistical model chosen, the ana-lytical method should be consistent with the data and documented in the data summary along with results.
Examples of possible analysis objectives and possible report descriptions.
10 PDA Journal of Pharmaceutical Science and Technology
3.5.4Data Interpretation
Data generated should be summarized and evaluated to determine whether the production environment is in a state of control. Statistical process control is one method of performing this evaluation.
Trends may show a gradual increase or decrease in the overall counts observed over time, or a change in flora or counts on several plates of a particular area on a given day. Interpretation of the impact of a significant fluc-tuation in counts or a change in flora should be based on the experienced judgment of a qualified person. Some considerations for assessing process state of con-trol are listed below:
a.In assessing environmental monitoring process re-
liability, derived action levels reflecting higher val-ues than those currently imposed may be indica-tive of a process specification that is no longer ap-propriate. A review of the process may be needed.
b.Several consecutive points or drifts may be con-
sidered to be a pattern or cluster formation that, if above the alert level, signals a trend that requires an investigation.
c.Significant fluctuations or jumps in the values for
the process are also significant where recurring cycles may point to seasonal variations.
d.One or more values markedly higher or lower than
the majority of the data may or may not be process outliers.
Understanding the potential impact of the results gen-erated during environmental monitoring is critical to a successful environmental monitoring program.
3.6 Characterization of Isolates Characterizing microorganisms recovered from environ-mental and personnel monitoring is an important part of surveillance programs. The characterization system selected by the laboratory should be defined in writing, including the frequency of characterization and the stan-dard procedures for the methods.
Initially, many isolates may be characterized to estab-lish a database of the microorganisms found in the area.Characterization may include any of the following ex-amples: morphology, Gram stain, automated or manual identification systems. See Appendix B for additional information on identification systems.
Not all isolates need to be speciated, but they should be characterized sufficiently to develop a database. Once a database is established, the number of isolates char-acterized may decrease, but routine characterization should continue to determine whether isolates are part of the normal microbial flora or represent something different.
Characterization of isolates also may be useful in in-vestigating situations such as positive sterility test re-sults, positive media fill results, alert and action level excursions, or introduction of a common organism that may signal a developing resistance to a sanitizing agent.
A change in the microbial flora or the introduction of a previously undetected species might signify a change in a system that should be investigated. Characteriza-tions can be useful clues as to the possible source of isolates. For example, Staphylococcus species are com-monly found on skin and the former Pseudomonas spe-cies are usually associated with water. (Many of these species have been re-classified, e.g., Ralstonia pickettei, Buckholderia cepacia, Sterotrophomonas maltophilia.)
The characterization of microorganisms is qualitative and relies on scientific training and good judgment. Microorganisms recovered from production environ-ments may be highly stressed due to physical factors such as limited nutrients, contact with chemicals, or thermal stress. It may be difficult to obtain genus/spe-cies matches in identification system databases. The da-tabases for commercial test kits and identification sys-tems were designed originally for clinical isolates and may be incomplete with regard to industrial isolates; this may lead to misidentification of species or uniden-tifiable isolates. This area is continuing to be devel-oped and enhanced.
3.7 Investigations/Corrective Actions
When excursions occur, there may be a drift from the baseline. An investigation is needed to determine what happened and what should be done to prevent a recur-rence. Records should show that the excursions were recognized and appropriate follow-up occurred.
Vol. 55, No. 5, September/October 2001, Supplement TR13, Revised 11
The overall purpose of the investigative action is to es-tablish, to the greatest degree possible, a cause-effect relationship between the observed level of environmen-tal quality and causes for the excursions (i.e., sources of contamination).
To create consistency in the treatment of excursions, investigative and/or corrective action steps should be pre-specified in a written plan. A progression of inves-tigative/corrective actions or responses may be used in which sequential or multiple excursions require greater consideration than single or widely separate excursions. Likewise, excursions that occur in areas which are criti-cal to the manufacturing process may require a more rigorous investigation and corrective action than those occurring in areas that are judged less critical to the integrity of the manufacturing process.
When an alert/action level is exceeded, the following actions may be appropriate:
?Notify the appropriate management.
-Initiate an investigation to determine the causes
and consequences of the excursion from the
specified operating parameters.
?Perform corrective actions to address the problem, as needed. (A table of typical corrective actions fol-lows.)
?Follow-up review to assess effectiveness of correc-tive action.
The previous listing is not all-inclusive, as these rec-ommendations are only intended to suggest investiga-tive activities and corrective actions when sampling and laboratory failures have been ruled out. Appropriate corrective actions are dependent upon the individual facility’s design and process designs.
The reviewer may exert scientific judgment to postpone any corrective action until the result is confirmed and/ or an investigation has been completed. It may also be appropriate to provide management with a routine sum-mary of action level excursions for review. All correc-tive actions listed include an evaluation of the action for effect on the product.3.8 Documentation
The following list includes items to be considered for documentation records:
a.Date and time of test
b.Test method/procedure reference
c.Activity level at site during test
d Equipment identification
e.Location
f.Area classification
g.Schematics of areas showing sample site locations
h.Sample site (critical or non-critical)
i.Test results
j.Evaluator of results
k.Date results read
l.Alert and/or action level
m.Temperature and duration of incubation
n.Control test results
o.Certification date, validation date, and expiration date of media used
p.Characterization of contaminants
https://www.wendangku.net/doc/295832362.html, of reviewer
r.Reporting of data
s.Review of historical data
t.Change control system
u.Calibration date on instrumentation
v.Methodology, analysis used to specify action/alert levels
w.System for documenting investigative/corrective action:
(1)Description of deficiency
(2)Possible cause(s) of problem
(3)Identification of persons responsible for
relevant corrective action
(4)Description of action steps and their
schedule for implementation
(5)Evaluation of effectiveness of action steps
12 PDA Journal of Pharmaceutical Science and Technology
Typical corrective actions for different systems.
Vol. 55, No. 5, September/October 2001, Supplement TR13, Revised 13
4.0SYSTEM SURVEILLANCE
4.1Introduction
4.1.1Terminal Sterilization
The terminal sterilization environmental control pro-gram is concerned with microbial flora that contributes to the bioburden and endotoxin content of the product prior to sterilization. This includes distilled water, ster-ilizer cooling water, treated water and city water. Air, surfaces, and microbial levels of containers and clo-sures are also routinely monitored. While control of the environment in which the products are prepared is im-portant, the most critical aspect of the program is the bioburden of the filled product to be sterilized. Con-trolling this aspect of the manufacturing process en-sures that the spore (heat resistant) bioburden levels presented to the product sterilization cycle do not ex-ceed the validated capabilities of the process and that the desired sterility assurance levels are achieved.
4.1.2Aseptic Filling
The aseptic environmental control program is specifi-cally designed to determine the number and type of microorganisms associated with direct assembly or preparation of product prior to sealing of the filled con-tainers. The number of sample sites and frequency of monitoring are generally greater than that monitored for established terminal sterilization processes. Air, water, personnel, compressed gases, floors, walls, ma-chinery, and other surfaces within the filling room are routinely monitored. Adequate environmental control is an integral part of the aseptic manufacturing process and a critical factor in contributing to sterility assur-ance. A review of the routine environmental control data should be included in the manufacturing documenta-tion for aseptically filled products.
4.1.3Isolation Technology
The environmental control program for aseptic filling isolator systems may be similar to that used for a con-ventional aseptic filling operation with the exception of surface and personnel monitoring. After sufficient data is collected, routine surface and air monitoring may not be warranted if a validated sanitization cycle exists for the interior surfaces of the isolator. However, par-ticulate air sampling might be performed routinely if the product might be adversely affected by higher than normal environmental particulate levels. Surface moni-toring may be used during initial validation runs to sup-port the effectiveness of the sanitization cycle and main-tenance of clean isolator surfaces between sanitization cycles. If surface monitoring is performed, it should be done after the completion of filling so as to not introduce any extraneous contamination or residual growth media during the filling operation. Monitoring of personnel is not required for isolator systems, however, monitoring of isolator gloves/half-suits should be considered.
4.2Water Monitoring
Water is a widely used substance, raw material, or in-gredient in the production, processing, and formulation of many pharmaceutical products. Control of the mi-crobial quality of water is of great importance in the pharmaceutical manufacturing facility since it may be used for formulating product, as well as for various washing and rinsing processes. Once a water system is validated and shown to be in a state of control, appro-priate samples should be taken from the holding and distribution system to assess the microbiological qual-ity of the water for its intended use. As pointed out in other sections of this report, there are many consider-ations in establishing an appropriate site for sampling (e.g., facility design, line configurations, validation data, process, historical data, test methodology, etc.). For additional information, see the Appendix C.
In the United States, the source or feed water should meet the requirements of the National Primary Drink-ing Water Regulations (NPDWR) (40 CFR 141) issued by the Environmental Protection Agency (EPA). There is a corresponding EU drinking water standard. These requirements ensure the absence of coliforms.
Note: the plate count methodologies described below were obtained from the Standard Methods for the Ex-amination of Water and Wastewater, 19th edition.
It is recognized, however, that other combinations of media, time, and temperature of incubation can be ap-propriate. Recommended methodologies from “Water for Pharmaceutical Purposes” general information chap-ter <1231> of USP 24 are described below.
14 PDA Journal of Pharmaceutical Science and Technology
公安机关办理行政案件 程序规定 ----------------------培训材料 第一部分一般程序 一、行政案件来源: 检查发现;举报;投诉;移送;火灾事故调查发现;同级政府或上级机关交办等。 二、对各种案源的处理: 填写《受案登记表》进行初步审查,并视情处理。 (一)同时具备下列三个条件的,调查处理: 1、有违法事实; 2、需要追究行政责任; 3、属于本公安消防机构管辖。 (二)不予受理: 不属于本公安消防机构管辖,告知报案人。 (三)具有下列情形之一的,不予处理: 1、没有违法事实; 2、违法情节轻微,不需要追究行政责任;
3、有其他依法不予追究行政责任情形的。 程序要求: (1)内部审批; (2)受害人报案的,制作《不予处理决定书》,3日内送达;无法送达的,应当注明。 三、《受案登记表》的运用:*1、不管是报案的还是监督检查发现的,只要进入行政办案程序的,均应填此表; 2、一案一填,同一事件有两个或两个以上违法嫌疑人因不同案由被查处的,应分别填写受案登记表;一案多人且相同案由的可合用一表,但应注明各违法嫌疑人的情况(审批表中同,但对每一名违法嫌疑人员的处理意见必须分别写明,审批人部分同意或不同意承办意见的,应当具体写明审批意见)。 3、表中案由按受案时掌握的情况,对照消防法四十四种案由填写,一般表述为:“涉嫌违法主体+案由”。 四、报案人提供的有关证据材料、物品等,应当登记。 登记单一式两份,加盖公安消防机构印章,注明提供人、接收人,一份给提供人,一份归档备查。同时对证据材料、物品采取固定保全措施,明确专人妥善保管。 第二节调查 一、基本要求
(一)全面: 对象——行为人本人,受害人、证人等; 内容——有无违法行为;违法行为轻重,包括: 1、违法嫌疑人的基本情况; 2、违法行为是否存在; 3、违法行为是否为违法嫌疑人实施; 4、实施违法行为的时间、地点、手段、后果及其他情节; 5、违法嫌疑人有无法定从重、从轻、减轻以及不予处理的情形; 6、与案件有关的其他事实。 (二)合法: 1、双人办案(当场处罚除外); 2、表明执法身份; 3、依法定程序调查。 (三)及时 一、传唤: 1、对象:只能是行政案件的违法嫌疑人,不得对违法嫌疑人的亲属、证人等其他人员进行传唤。 对涉嫌违法单位,应当传唤本案直接负责的主管人员和其他直接责任人员。 2、适用情形:需要传唤违法嫌疑人到公安消防机构或所在地其他指定地点接受讯问。到违法嫌疑人住处或单位讯问不办传唤手续;
1目的 为了明确对可能产生环境影响的相关服务过程及结果进行监视和测量的方法和要求,使相关监视和测量活动能够按规定要求开展,及时了解和掌握相关环境因素的变化情况,确保环境管理体系的相关活动有效地进行,特制订本程序。 2适用范围 公司各管理服务中心对重要环境因素的监视和测量均适用于本程序。 3职责 3.1管理服务中心:负责对法律法规要求的执行情况及办公用品的使用情况进行监测,并负 责与环境监测活动有关的外部联系。 3.2工程部:负责对水、电、气等能源的使用情况及重要环境因素的变化情况进行相应的监 测活动,并负责对相关监测仪器的管理。 3.3物流中心:负责组织相关部门对相关供应商的环境因素管理状况进行监测。 3.4管家部:负责对固体废弃物的排放情况进行监测。 3.5其它部门:负责对本部门服务用品的耗用情况及本部门工作范围内相关方的环境因素控 制状况进行监测。 4引用文件 4.1《内部审核程序》 4.2《纠正及预防措施程序》 4.3《检测设备控制程序》 4.4相关监测作业指导书 5程序内容 5.1环境监测内容 相关部门在服务过程中主要应对以下方面的活动实施相应的监测: 5.1.1重大环境因素的管理状况。 5.1.2水、电、气、油、服务用品等资源的耗用情况。 5.1.3环境目标与指标的完成情况。 5.1.4法律法规的遵循情况。 5.1.5可施加影响的相关方的重大环境因素的管理状况。 5.1.6环境管理体系运行状况。
5.2监测方法 5.2.1重大环境因素的监测 1)已具备相关监测条件的管理服务中心,其工程部及管家部应按照相关作业程序或 作业指导书的要求,定期对污水、噪声、固体废弃物、放射性废弃物的排放情况 进行监测,并将监测结果记录在相应的监测记录及《月度环境检查报告》中。 2)暂未具备相关监测条件的管理服务中心,则应由信息处理中心或委托具有相关资 格的环境监测机构对服务范围内的相关排放物进行监测,并保留对相关排放物的 监测记录或监测报告。 5.2.2环境管理体系运行状况的监测 环境管理体系内审小组应按《内部审核程序》的要求,对环境管理体系的充分性、 适宜性及有效性进行审核和评价,并将审核的结果记录在《内审检查表》中。 5.2.3法律法规要求遵循情况的监测 1)管理者代表应每6个月组织相关人员对各管理服务中心相关法律法规要求的收集 情况及遵循情况进行检查,并将检查的结果记录在《月度环境检查报告》中。 2)信息处理中心应每2个月对本管理服务中心的法律法规要求的收集及遵循情况进 行检查,并将检查结果记录在当月的《月度环境检查报告》中。 5.2.4环境目标/指标及办公用品使用情况的监测 信息处理中心应对相关部门的环境目标/指标的完成情况及办公用品的使用情况进 行检查,并将检查结果记录在《月度环境检查报告》中。 5.2.5日常环境管理状况的监测 相关部门应按环境管理体系文件的要求,在日常服务过程中对所属人员的环境管理 状况进行检查,并将检查结果记录《服务日检表》、《服务周检表》及《服务月检表》 中。 5.2.6资源消耗情况的监测 1)工程部应对服务范围内水、电、气、燃油等资源的耗用情况进行监测和统计,并 将相关资源的耗用情况记录在《水电气耗用情况统计表》中。 2)信息处理中心还应对各部门办公用品的使用情况进行统计,并将统计结果记录在 《办公用品耗用情况统计表》中。 3)相关部门应对本部门使用的相关物品及工具的耗用情况进行检查,并将检查结果
1、根据《治安管理处罚法》的规定,下列表述错误的是()。 A.被处罚人和被侵害人都有权申请行政复议 B.被处罚人申请行政复议的,被侵害人可以作为行政复议案件的第三人 C.被处罚人可以申请行政复议,也可以提起行政诉讼 D.被处罚人提起行政诉讼应当先申请行政复议 【正确答案:】D 2、刘某将在公交车上盗走其手机(价值600元)和近100元人民币的张某扭送至公安机关,张某矢口否认盗窃,但手机等物证以及其他乘客能够证明刘某实施盗窃,公安机关据此()作出治安管理处罚决定。 A.可以 B.不能 C.待张某承认后才能 D.找到现场视频录像后才能 【正确答案:】A 3、治安案件调查结束后,对确有依法应当给予治安管理处罚的违法行为的,公安机关应当根据(),作出处罚决定。 A.案件性质 B.情节轻重及具体情况 C.案件后果及相关因素 D.违反治安管理行为人的态度、表现 【正确答案:】B 4、治安案件调查结束后,公安机关对(),作出不予处罚的决定。 A.依法不予处罚的,或者违法事实不能成立的 B.违法行为已涉嫌犯罪的 C.发现违反治安管理行为人有其他部门管辖的违法行为的 D.确有违反治安管理的行为,但不满16周岁的 【正确答案:】A 5、公安机关在调查甲殴打他人的案件中,发现被侵害人乙的伤情已构成轻伤,应当()。 A.依法不予治安管理处罚 B.作出治安管理处罚的决定 C.通知有关主管部门处理 D.移送主管机关依法追究刑事责任 【正确答案:】D
6、根据《治安管理处罚法》的规定,下列说法错误的是()。 A.治安管理处罚决定书应当由作出处罚决定的人民警察签名并盖章 B.对治安管理处罚决定不服,被处罚人有权申请行政复议 C.对决定给予行政拘留处罚的,公安机关应当及时通知被处罚人的家属 D.有被侵害人的,公安机关应当将决定书副本抄送被侵害人 【正确答案:】A 7、某公安局对外来务工人员张某作出治安管理处罚决定,因无法送达张某,下列可以为张某代收法律文书的是()。 A.张某17岁的儿子 B.张某所在单位的传达室 C.张某户籍所在地的村民委员会 D.张某80岁的父亲 【正确答案:】D 8、对阻碍海关缉私警察依法执行职务的治安案件,由()行使查处权。 A.县级以上人民政府公安机关治安管理部门 B.县级以上人民政府公安机关 C.县级以上海关 D.海关系统相当于县级以上公安机关的侦查走私犯罪公安机构 【正确答案:】D 9、下列不能行使治安管理处罚权的是()。 A.公安派出所 B.海关系统相当于县级以上公安机关的侦查走私犯罪公安机构 C.人民政府综合执法机构 D.铁路、民航、交通和森林公安机关 【正确答案:】C 10、根据《治安管理处罚法》的规定,罚款与行政拘留并处的,其处罚决定权限表述正确的是()。 A.只要罚款是500元以下的,不论是否并处行政拘留,公安派出所都有权作出 B.只要处罚中涉及行政拘留,不论是否并处罚款,只能由县级以上公安机关作出处罚决定 C.其中500元以下的罚款只能由公安派出所作出,并处的行政拘留由县级以上公安机关作出 D.根据县级公安机关的授权,500元以下的罚款,并处行政拘留的可以由公安派出所作出 【正确答案:】B 11、公安派出所有权对违反治安管理行为人罚款的最高额是()元。 A.200 B.5000
环境监测和测量管理程序 1.目的 对可能具有重大环境影响的运行和活动的关键特性进行监控与测量,以便及时掌握公司及可能施加影响相关方的环境绩效,对法律法规遵循情况及与有关运行控制、目标与指标运行的符合情况。 2.范围 本程序适用于对环境表现、有关的运行控制、环境目标、指标符合情况、法律法规遵循情况等的监控与管理。 3.职责: 3.1 行政人事部负责联系法定检测部门对公司的污染物排放进行定期监测和测量;负责对废弃物的处置并统计排放量。 3.2 设备动力科负责统计能源的使用情况和对环境监测设备进行校准及维护。 3.3 环境管理者代表负责对环境表现、有关的运行控制、环境目标和指标符合情况、法律法规的遵循情况等进行监督检查。 4.工作程序 4.1 环境监测的基本要求 4.1.1 外部监测项目 环保局—— 监测站—— 消防局—— 4.1.2内部监测项目 4.1 公司对可能具有重大环境影响的运行与活动的关键特性进行例行监测。 4.1.1 行政人事部负责联系地方环境监测站等法定监测部门对公司的噪声、废水、废气等污染物进行每年一次的定期监测与测量,测量结果交环境管理者代表,经评价后反馈给相关部门。 4.1.2 当监测结果出现不符合时,按照《纠正和预防措施控制程序》进行处理。 4.1.3 所有监测设备、能源计量设备都和质量管理体系中检测设备同样作法,具体详见《监视和测量装置控制程序》。
4.1.4 行政人事部负责组织对废弃物进行合理处置,每月分类统计一次,结果记录在《废弃物处置统计表》中。 4.1.5 水、电、气、燃料(油)等类别每月由设备动力部统计公司总的能耗,记录于《能源使用统计表》中。 4.2 环境管理者代表组织品质管理部实施,对环境目标和指标的符合情况、办公环境行为执行情况等随时进行监督检查,记录《环境目标和指标完成情况检查表》、《环境管理体系适用法规评审表》和《办公环境行为检查表》,每半年全面评价一次;当出现不符合情况时,按照《纠正和防措施控制程序》进行处理。 4.3法律法规评价每年一次由环境管理者代表负责,通常在管理评审之前进行,特殊情况应及时执行。主要检查法律法规识别、收集是否齐全;适用条款是否标明;执行的环保标准是否准确。检查方法主要是比对公司环境表现与法律法规要求,对执行情况进行评价;评价结果记录《合规性评价表》;评审发现不合格时按《纠正和预防措施控制程序》进行处理。 5、相关文件 5.1《监视和测量装置控制程序》 5.2《纠正和预防措施控制程序》 5.3《运行控制程序》 6、相关记录 6.1 《污染监测记录表》行政人事部保存,期限一年; 6.2 《废弃物处置统计表》行政人事部保存,期限一年; 6.3 《能源使用统计表》设备动力科保存,期限一年; 6.4 《合格性评价表》品质管理部保存,期限一年; 6.5 《环境目标和指标完成情况检查表》品质管理部保存,期限一年; 6.6 《办公环境行为检查表》品质管理部保存,期限一年;
行政案件第一审程序开庭审理规范 (1994年6月2日市高级人民法院 审判委员会第27次会议原则通过) 为依法正确及时审理行政案件,提高行政案件开庭审理的质量和效率,根据《中华人民共和国行政诉讼法》及有关法律和司法解释的规定,结合本市审判实践,制定本规范。 开庭前的准备 一、开庭审理前审判长主持召开合议庭准备会议。书记员作好会议记录。准备会议应当再次核对本案立案是否符合行政诉讼法第41条规定的条件。发现不属于人民法院受案范围或不符合起诉条件的,裁定驳回起诉;发现不属于本院管辖的,移送有管辖权的法院审理;发现诉讼当事人有误的,依法变更或增加诉讼当事人。 合议庭准备会议还应安排以下议程: (一)由主审人介绍案情和阅卷情况; (二)合议庭成员认真审核诉讼材料,明确本案的审理对象和审查重点,了解被诉具体行政行为的法定构成要件和与案件有关的法律规范,分析研究开庭审理中可能出现的问题和对策; (三)研究和确定庭审提纲; (四)明确合议庭成员在庭审中的分工及合议庭成员是否提出回避; (五)确定是否公开开庭以及是否传证人到庭,确定开庭的时间、地点及是否邀请有关人员旁听。 二、书记员在法定期限内张贴公告,向诉讼当事人发送传票,向诉讼代理人及其他诉讼参与人发出出庭通知,通知法警按时执行公务。公开审理的案件应及时发出旁听券。 三、审判区应当符合以下要求:审判长的座位位于国徽下正中处,审判员或陪审员分坐两边;法台右前方为书记员座位,同法台成45°角;法台左前方为证人、鉴定人、翻译人员座位,同法台成45°角;当事人及诉讼代理人座位设在法台前方,右边为原告座位,左边为被告座位,第三人座位设在原告一侧;当事人
绪论 1. 环境监测的目的:1)评价环境质量是否符合国家制定的环境质量标准。2)根据污染物或其他影响环 境质量因素的分布,追踪污染路线,寻找污染源。3)确定污染源所造成的污染影响,它在时间和空间上 的分布规律,及其发展、迁移转化情况。4)研究污染扩散模式和规律,为预测预报环境质量,控制环境 污染和环境治理提供依据。5)收集环境本底及其变化趋势数据,积累长期监测资料。为保护人类健康和 合理使用自然资源提出建议,为制订和修改环境标准提供数据。 2. 环境监测的分类:1)监视性监测(又称例行监测或常规监测;2)特定目的监测(又称为特例监测);3)研究性监测(又称科研监测) 3. 环境污染的特点:1)时间分布性:同一污染源在不同时间对同一地点造成的污染物浓度可能相差很大,在环境中污染物浓度随时间分布不是均匀的。2)空间分布性:不同污染物的稳定性和扩散速度与污染物 的性质有关,因此不同位置上的污染物的浓度和强度分布是不同的。3)环境污染与污染物含量的关系: 有害物质引起毒害的两与其无害的自然本值之间存在一界限4)环境因素的综合效应:环境是一个由生物 和非生物组成的复杂体系,因此存在各种因素的综合效应。 4. 单独作用:机体中某些器官只是由于混合污染物中某一组分对其发生危害,没有因为污染物共同作用而加深危害的,称为污染物的单独作用。 5. 相加作用:混合污染物各组分对机体的同一器官的毒害作用彼此相似,且偏向同一方向,混合污染物对机体的毒害相当于各种污染物毒害的总和,称为污染物的相加作用。 6. 相乘作用:混合污染物对机体的毒害作用超过个别毒害作用的总和,称为相乘作用。 7. 拮抗作用:混合污染物中有两种或两种以上物质对机体的毒害作用彼此抵消大部分或一部分时,称为拮抗作用。 8. 环境监测--为某种特定目的,按照预先设计的时间和空间,间断或连续地,对环境质量的代表值进行测定,并观察、分析其变化及其对环境影响的过程。 9. 环境要素:环境整体中,各自独立的,性质不同但又服从整体演化规律的基本物质组分,称为环境要素。包括:自然环境要素和社会环境要素。 10. 环境质量是指在一个具体的环境内,环境的总体或某些要素,对人群的生存和繁衍以及社会经济发展 的适宜程度 11. 环境污染按环境要素分类分为:大气污染,水体污染,土壤污染,生物污染 12. 按污染物的性质分类:化学污染,生物污染,物理污染 13. 环境监测的特点:综合性,连续性,追踪性 14. 从众多有毒污染物中筛选出潜在危害大、在环境中出现频率高的污染物作为监测和控制的对象,经过 优先选择的污染物称为环境优先污染物,对优先污染物的监测称为优先监测。 15. 环境标准的作用:1)环境标准是环境保护的工作目标:它是只环境保护规划和计划的重要依据2)是判断环境质量和衡量环境工作优劣的准绳3)是执法的依据:环境问题的诉讼、排污费的收取等的依据都 是环境标准4)是组织现代化生产的准备手段和条件:通过实施可以促使企业对污染进行管理和治理,更 新设备等。总之,环境标准是环境管理的技术基础。 16. 环境标准分为国家标准和地方标准两级。 水和废水监测 1. 水质监测分为环境水体监测和水污染源监测。环境水体包括地表水(江河湖海)和地下水;水污染源包括工业废水、生活污水、医院污水等。
51单片机智能环境监测系统程序 王维进 #include
sbit K3=P1^5;//减 sbit K4=P1^7; //人体 sbit K5=P1^6; //布防撤防按键 sbit LED1=P3^1; //烟雾报警 sbit LED2=P3^2; //温度上限 sbit LED3=P3^3; //温度下限 sbit LED4=P3^4; //湿度上限 sbit LED5=P3^5; //湿度下限 sbit LED6=P3^6; //红外报警 sbit alarm=P3^0; //蜂鸣器 uchar U8FLAG,U8temp,U8comdata,U8RH_data_H_temp,U8RH_data_L_temp,U8T_data_H_temp,U8T_data_L_temp ,U8checkdata_temp; uchar U8RH_data_H,U8RH_data_L,U8T_data_H,U8T_data_L,U8checkdata; uchar Mode,humidity,temperature,smog; bit BJ_LED1=1,BJ_LED2=1,BJ_LED3=1,BJ_LED4=1,BJ_LED5=1,BJ_LED6=1; bit bdata FlagStartRH; uchar flag ;//记录当前设置状态 uint count; //定时器0初始化 void Timer0_Init() { ET0 = 1; //允许定时器0中断
环境监测基础知识 复习题 环境监测中心 二○○六年七月 目录 一、国家标准及技术规范基础1-4页 二、实验室基础、质量保证及质量控制4-7页 三、水质监测实验室基础8-21页 四、空气和废气监测基础21-26页 五、金属类监测基础26-31 六、有机物监测基础31-36页
一、国家标准及技术规范基础 1、实施污染物排放总量控制是推行可持续发展战略的需要。(对) 2、建设项目建成投入生产或使用后,必须确保稳定达到国家或地方规定的污染物排放标准。(对) 3.为了推动我国火电行业对SO2的治理工作,实行SO2排放总量与排放浓度双重控制。(对) 4、噪声的来源主有交通噪声、工业噪声、建筑施工噪声和社会噪声。人耳开始感到疼痛的声音叫做痛阈,其声级为120分贝(dB)左右。(对) 5、《环境空气质量标准》(GB3095-1996)将环境空气质量标准分为三级。(对) 6、《环境空气质量标准》(GB3095-1996)将环境空气质量功能区分为三类。(对) 7、《污水综合排放标准》GB8978-1996中规定,石油类和动、植物油的测定方法为测定方法为红外分光光度法。(对) 8、我国1983年颁布了第一个汽车污染物排放标准和测试方法标准。(对) 9、监测工业废水中的一类污染物应在车间或车间处理设施排放口布点采样。(对) 10、建设(包括改、扩建)单位的建设时间,以环境影响评价报告书(表)的批准日期为准。(对) 11、新污染源的排气筒高度一般不应低于15米。若某新污染源的排气筒必须低于15米时,其排放速率标准值按外推计算结果再严格50%执行。(对) 12、《污水综合排放标准》(GB8978-1996)中的挥发酚指能与水蒸气一并挥发的酚类化合物。(对) 13、锅炉排放二氧化硫浓度应在锅炉设计出力70%以上时测定。(对) 14、污染源大气污染物排放中的最高允许排放速率,是一定高度的排气筒任何1h排放污染物的质量不得超过的限值。(对) 15、《污水综合排放标准》GB8978-1996以标准分布时所规定的实施日期为界,划分为两个时段。即1997年12月31日前建设的单位,执行第一时间段规定标准值;1998年1月1日起建设的单位执行第二时间段规定标准值。(对) 16、建设项目试运行期间,污染物排放达不到规定排放标准的,负责验收的环境保护行政主管部门可根据建设项目的具体情况,要求建设单位限期达到规定的污染物排放标准;在实行污染物总量控制的地方,还应达到当地污染物排放总量控制的要求。(对) 17、危险废物腐蚀性鉴别,当pH大于或等于12.5,或者小于或等于2.0时,则该废物是具有腐蚀性的危险废物。(对) 18、我国的环境标准有国家标准、行业标准、地方标准、企业标准。(对) 19、烟尘的排放量主要受到燃烧方式、锅炉运行情况和煤的性质,还有锅炉负荷的影响。(对) 20、产污和排污系数的物理意义是指单元活动所产生和排放的污染物量。(对) 21、排污系数是指产污系数条件下经污染控制措施削减后或未经削减直接排放到环境中污染物的量。(对) 22、排污系数的物理意义是:每耗用1t煤产生和排放污染物的量。(对) 23、浸出液中任何一种危害成分的浓度超过其标准中所列的浓度值,则该废物是具有浸出毒性的危险废物。(对) 24、环境质量标准、污染物排放标准分为国家标准和地方标准。(错) 25、国家污染物排放标准分综合性排放标准和行业性排放标准两大类。(对) 26、低矮排气筒的排放属有组织排放,但在一定条件下也可造成与无组织排放相同的后果。(对) 27、工业废水样品应在企业的车间排放口采样。(错) 28、新污染源的排气筒高度一般不应低于15米。(对) 29、地表水环境质量标准规定I~Ⅳ类标准的水质pH值为5~6。(错) 30、排放污染物的烟囱是污染源,而排放大气污染物的建筑构造(如车间等)不能算是污染源。(错) 31、排气筒高度的计算是指自排气筒(或其主体建筑构造)所在的地平面至排气筒出口的高度。(对) 32、烟度标准中拟控制的是柴油车运行中的平均烟度。(错) 33、柴油机车排放的碳烟比汽油机车大40倍左右。(对) 34、柴油机排放的SO2明显比汽油机浓度值高。(对)
《公安机关办理行政案件程序规定》 本题库:判断(49题)、单项选择(53题)、多项选择(63题),总计165题。 一、判断题(49题) 1、《公安机关办理行政案件程序规定》不适用于公安机关办理的强制戒毒、收容教育等强制措施的案件。(×) 2、《公安机关办理行政案件程序规定》只能适用于公安机关依照法律、法规和规章的规定对违法行为人决定行政处罚的案件。(×) 3、行政拘留并处罚款的,罚款不因暂缓执行行政拘留而暂缓执行。(√) 4、因违反治安管理人逃跑等客观原因,导致无法查清案件事实,无法收集足够证据而结不了案的,公安机关应当向被侵害人说明原因。(√) 5、被处罚人拒绝缴纳罚款的,可以处15日以下拘留,罚款仍应执行。(×) 6、公安机关办理行政案件应当遵循合法、公正、公开、及时的原则,尊重和保障人权,保护公民的人格尊严。(√) 7、行政案件如果由违法行为发现地公安机关管辖更为适宜的,应当由违法行为发现地公安机关管辖。(×) 8、几个公安机关都有权管辖的行政案件,由最初受理的公安机关管辖。(√) 9、当事人及其法定代理人要求公安机关负责人、办案人员回避的,应当提出申请,并说明理由。(√) 10、对当事人及其法定代理人提出的回避申请,公安机关应当在5日内作出决定并通知申请人。(×) 11、当事人及其法定代理人要求公安机关负责人、办案人员回避的,自提出回避申请之日起,公安机关应当停止办案人员对行政案件的调查。(×) 12、在公安机关作出回避决定前,办案人员不得停止对行政案件的调查。(√) 13、上级公安机关直接或指定管辖的,不受行为地管辖原则限制。(√) 14、公安机关及其人民警察在办理行政案件时,对涉及的商业秘密或者个人隐私,当事人要求保密的,应当保密。(×) 15、对扣押物品进行鉴定、检测、检验的期间不计入扣押期间,但应当将鉴定、检测、检验时间告知当事人。(√) 16、在行政拘留处罚前因同一行为已经被采取继续盘问措施限制人身自由24小时, 1
公安机关办理行政案件程序规定 (判断题) 1、行政案件由违法行为发现地的公安机关管辖。() 答案:× 2、几个公安机关都有权管辖的行政案件,由主要违法行为地公安机关管辖。() 答案:× 3、对管辖权发生争议的,报请共同的上一级公安机关制定管辖。() 答案:√ 5、根据《公安机关办理行政案件程序规定》的规定,电子邮件应归属于书证。() 答案:× 6、聋哑人提供的书面证词属于《公安机关办理行政案件程序规定》所规定的“书证”。() 答案:× 7、在盗窃案件中,被侵害人出具的被盗物品的购买发票属于书证。() 答案:√ 8、生理上、精神上有缺陷或者年幼的人,不能作为证人。()
答案:× 9、凡知道案件情况的人,都有作证的义务。() 答案:√ 10、办案人民警察依照简易程序作出当场处罚决定,将决定书当场交付被处罚人时,被处罚人拒绝签名和盖章的,办案人民警察应当在备案的决定书上注明。() 答案:√ 11、违法事实确凿,对违反治安管理行为人处200元以下罚款或者警告的,人民警察可以当场作出处罚决定,有违禁品的,可以当场收缴。() 答案:√ 12、对有违反治安管理行为或者道路交通违法行为以外的其他违法行为的个人或单位处50元以下罚款或者警告的,人民警察可以当场作出处罚决定,有违禁品的,可以当场收缴。() 答案:× 13、当场处罚的,办案人民警察对违法行为人提出的事实、理由或者证据应当采纳。() 答案:× 14、公安机关对行政案件进行调查时,可以使用一切手段收集、调取证据材料,并予以审查、核实。()答案:×
15、公安机关在调查取证时,人民警察可以一人,但应当向被调查人员表明执法身份。() 答案:× 16、人民警察对查获或者到案的违法嫌疑人,应当在开具检查证后进行安全检查,发现管制刀具、武器、易燃易爆等危险品的,应当立即予以扣押。() 答案:× 17、人民警察对查获或者到案的违法嫌疑人可以进行安全检查,发现管制刀具、武器、易燃易爆等危险品的,应当立即予以扣押。() 答案:× 18、人民警察对查获或者到案的违法嫌疑人进行安全检查时不需要开具检查证。() 答案:√ 19、违法嫌疑人在醉酒状态中,对本人有危险或者对他人的人身、财产或者公共安全有威胁的,可以对其使用手铐、脚镣等警械约束至酒醒,也可以通知其所属单位或者家属将其领回看管。() 答案:× 20、违法嫌疑人在醉酒状态中,对本人有危险或者对他人的人身、财产或者公共安全有威胁的,可以对其采取保护性措施约束至酒醒,也可以通知其所属单位或者家属将其领
环境监测实验室规章制 度流程 集团公司文件内部编码:(TTT-UUTT-MMYB-URTTY-ITTLTY-
化学分析室管理规范 1、实验人员进入实验区工作时必须穿工作服,实验完毕清洗双手。 2、与分析、检测工作无关的人员不得随意进入实验室,非工作人员进入实验 在未经该室管理人员许可的情况下不得随意使用仪器及附属设备。 3、与分析、检测工作无关的物品禁止带入实验室,严禁在实验室内抽烟、喝水、吃食 物。 4、实验室内保持清洁、整齐、安静,随时注意地面、桌面、仪器的整洁。实验台面须每 天擦拭,除配置好的试剂、移液管外,其他实验物品均放置在指定位置,不可随意摆放。地面至少每周打扫两次,并保证无浮尘、无污渍。 5、实验过程中应将滤纸、试纸等投入废纸篓中,废液倒入废液桶中。 6、实验过程中如发生安全事故,室内人员保持镇静,按有关急救措施处理,熟悉使用消 防器材(如灭火器等)。? 7、在实验结束及节假日期间,各实验室人员须认真检查自己所负责的电源、火源、水 源、气源及门窗等安全状况,确保实验室安全。 天平室管理规范 1、天平室内应保持安静,动作要轻缓。 2、出入天平室随手关门,除放置与天平使用有关的物品外,不得放置其它物品。 3、称量前检查天平是否处于水平位置,如有异常,即时调整至水平位置。 4、称量物不得超过天平的最大载重量(120g),称量精度在0.01g以下的试剂及样品不 可使用分析天平。 6、不得在天平里称量或转移挥发性、腐蚀性的试剂。
7、开、关天平要轻、缓,称量的物品必须放在适当的容器中,不可直接置于天平托盘 内。 8、称量结束后,关闭天平,取下被称量物体,切断电源,清洁台面,罩好天平罩,填写 天平使用记录。 9、天平室管理员须定期维护、检查分析天平,天平框内硅胶干燥剂蓝色消失后及时烘干 更换。 10、在天平周围不可放置太多的样品、试剂,及时将已称量完的样品、试剂放回留样柜或 试剂室内。 原子吸收室管理规范 1、分光光度室内除仪器及电脑外不得有其他无关物品存放。 2、开机前取出挡光板,开机后若不用紫外光区,关闭氘灯,实验全过程保持卫生。 3、比色皿使用完毕后,请立即用蒸馏水冲洗干净。 4、仪器使用时应打开比色皿盖或使用挡光杆,如连续使用中间应适当使之避光休息。 5、分光光度计务必防止洒进液体,应及时擦干净,干燥剂应定期更换或烘烤。 6、避免强电场、避开腐蚀性气体、避免与较大功率的电器设备共电。 7、样品测试完毕后,放好挡光板,关闭电源,清理桌面,盖好防尘罩,废液桶移出光度 室。 气相色谱室管理规范 1、实验室内保持清洁、整齐、安静,随时注意地面、桌面、仪器的整洁。 2、仪器开机前应确保电路、气路正常、安全,并每月进行检查,且更换气瓶后必须对气瓶进行试漏检查。 3、①气瓶存须放在气瓶柜,使用过程中,发现有严重腐蚀和损伤时,应提前进行检验。
---------------------------------------------------------------范文最新推荐------------------------------------------------------ 行政处罚案件询问笔录 询问地点 询问时间年月日时分至时分 询问机关 询问人 记录人 被询问人:姓名性别年龄民族 文化程度职业工作单位 住址 问:__________________________________________________________答:__________________________________________________________ 宣告失踪申请书 申请人……(姓名、性别、年龄、民族、籍贯、职业或单位、住所) 被申请人……(姓名、性别、年龄、民族、籍贯、职业或单位、住所) 1 / 4
请求事项:___________________________________________________________ _______________________________ 事实与理由:___________________________________________________________ _____________________________ 此致______人民法院 申请人:___(签名或盖章) _____年_______月_______日 附:有关证据及材料。 注: 宣告失踪是指经利害关系人的申请,由人民法院依照法律规定的程序,宣告下落不明满一定期限的公民为失踪人的民事法律制度。宣告失踪的条件和程序为:①公民下落不明满二年的,战争期间下落不明的,下落不明的时间从战争结束之日起计算。②利害关系人向人民法院申请宣告他为失踪人。利害关系人包括他的配偶、父母、成年子女或者关系密切的其他亲属,如祖父母、外祖父母、孙子女、外孙子女等。公民被宣告为失踪人后,失踪人的财产由他的配偶、父母、成年子女或者关系密切的其他亲属、朋友代管。对没有法定代管人或者代管有争议的,由人民法院指定的人代管;失踪人所欠税款、债务和应付的其他费用,由代管人从失踪人的财产中支付。被宣告失踪的人重新出现或者确知他的下落,经本人或者利害关系人申请,人民法院应
重庆市环境监测基础知识竞赛 目录 一、国家标准及技术规范基础 二、实验室基础、质量保证及质量操纵 三、水质监测实验室基础 四、空气和废气监测基础 五、金属类监测基础 六、有机物监测基础 一、国家标准及技术规范基础 1、实施污染物排放总量操纵是推行可持续进展战略的需要。(对) 2、建设项目建成投入生产或使用后,必须确保稳定达到国家或地点规定的污染物排放标准。(对)
3.为了推动我国火电行业对SO2的治理工作,实行SO2排放总量与排放浓度双重操纵。(对) 4、噪声的来源主有交通噪声、工业噪声、建筑施工噪声和社会噪声。人耳开始感到疼痛的声音叫做痛阈,其声级为120分贝(dB)左右。(对) 5、《环境空气质量标准》(GB3095-1996)将环境空气质量标准分为三级。(对) 6、《环境空气质量标准》(GB3095-1996)将环境空气质量功能区分为三类。(对) 7、《污水综合排放标准》GB8978-1996中规定,石油类和动、植物油的测定方法为测定方法为红外分光光度法。(对) 8、我国1983年颁布了第一个汽车污染物排放标准和测试方法标准。(对) 9、监测工业废水中的一类污染物应在车间或车间处理设施排放口布点采样。(对) 10、建设(包括改、扩建)单位的建设时刻,以环境阻碍评价报告书(表)的批准日期为准。(对) 11、新污染源的排气筒高度一般不应低于15米。若某新污染源的排气筒必须低于15米时,其排放速率标准值按外推计算结果再严格50%执行。(对)
12、《污水综合排放标准》(GB8978-1996)中的挥发酚指能与水蒸气一并挥发的酚类化合物。(对) 13、锅炉排放二氧化硫浓度应在锅炉设计出力70%以上时测定。(对) 14、污染源大气污染物排放中的最高同意排放速率,是一定高度的排气筒任何1h排放污染物的质量不得超过的限值。(对) 15、《污水综合排放标准》GB8978-1996以标准分布时所规定的实施日期为界,划分为两个时段。即1997年12月31日前建设的单位,执行第一时刻段规定标准值;1998年1月1日起建设的单位执行第二时刻段规定标准值。(对) 16、建设项目试运行期间,污染物排放达不到规定排放标准的,负责验收的环境爱护行政主管部门可依照建设项目的具体情况,要求建设单位限期达到规定的污染物排放标准;在实行污染物总量操纵的地点,还应达到当地污染物排放总量操纵的要求。(对) 17、危险废物腐蚀性鉴不,当pH大于或等于12.5,或者小于或等于2.0时,则该废物是具有腐蚀性的危险废物。(对) 18、我国的环境标准有国家标准、行业标准、地点标准、企业标准。(对)
《公安机关办理行政案件程序规定》题库 一、判断题 1、办理行政案件应当以事实为根据,以法律为准绳。(对) 2、办理未成年人的行政案件,应当根据未成年人的身心特点,保障其合法权益。(对) 3、办理行政案件,在少数民族聚居或者多民族共同居住的地区,可以使用当地通用的语言进行询问。对不通晓当地通用语言文字的当事人,可以为他们提供翻译。(错) 4、移交违法行为人居住地公安机关管辖的行政案件,违法行为地公安机关在移交前可以收集证据,但无需配合违法行为人居住地公安机关开展调查取证工作。(错) 5、几个公安机关都有权管辖的行政案件,由最初受理的公安机关管辖。必要时,可以由主要违法行为地公安机关管辖。(对) 6、对于重大、复杂的案件,上级公安机关可以指定管辖,但不能直接办理。(错) 7、对管辖权发生争议的,报请共同的上级公安机关指定管辖。(对) 8、上级公安机关指定管辖的,应当书面通知被指定管辖的公安机关和其他有关的公安机关。上级公安机关直接办理的可以不通知。(错) 9、国有林区的森林公安机关管辖林区内发生的行政案件。(对) 10、公安机关负责人、办案人民警察提出回避申请的,应当说明理由。(对) 11、当事人及其法定代理人要求公安机关负责人、办案人民警察回避的,应当提出申请,并说明理由。(对) 12、当事人及其法定代理人要求公安机关负责人、办案人民警察回避的,应当提出书面申请,口头提出申请的,公安机关不予受理。(错) 13、鉴定人和翻译人员不得申请回避的。(错)
14、证据必须经过查证属实,才能作为定案的根据。(对) 15、可以用于证明案件事实的材料,不一定都是证据。(错) 16、收集物证、书证不符合法定程序,可能严重影响执法公正的,不能作为定案的根据。(错) 17、公安机关必须依照法定程序,收集能够证实违法嫌疑人是否违法、违法情节轻重的证据。(对) 18、严禁刑讯逼供和以威胁、欺骗等非法方法收集证据。采用非法方法收集的证据不能作为定案的根据。(对) 19、收集物证、书证不符合法定程序,可能严重影响执法公正的,不能作为定案的根据。(错) 20、书证有更改或者更改迹象不能作出合理解释的,或者书证的副本、复制件不能反映书证原件及其内容的,不能作为证据使用。(对) 21、法律文书送达的期间包括路途上的时间。(错) 22、违法行为人被限制人身自由的期间,应当至期满之日为止,不得因节假日而延长。(对) 23、治安管理处罚决定应当在二日内送达。(错) 24、当场处罚不需收集证据(错) 25、当场处罚不需口头告知违法行为人拟作出行政处罚决定的事实、理由和依据,也不需告知违法行为人依法享有的陈述权和申辩权;(错) 26、当场处罚应当当场收缴罚款。(错) 27、适用简易程序处罚的,可以由人民警察一人作出行政处罚决定。(对) 28、公安机关调查取证时,应当防止泄露工作秘密。(对) 29、安全检查需要开具检查证。(错) 30、实施行政强制措施应当通知当事人到场,当场告知当事人采取行政强制措施的理由、依据以及当事人依法享有的权利、救济途径。当事人不到场的,邀请见证人到场,并在现场笔录中注明。(对)
环境监测控制程序文件编号:HG-EPD-21 版本:A/0 1 目的 明确并规定管理体系中环境监测活动和要求,确保管理体系中环境管理运行过程得到有效控制,以持续提高过程的有效性。 2 适用范围 公司可能造成重大环境影响有关活动,包括现有的重要环境因素的运行控制、环境现状、环境目标和指针的达成。 3 术语和定义(无) 4 职责 4.1 总务部负责建立并改进本程序。 4.2 总务部负责公司及相关部门能源及设施运行的监测。 4.3 总务部负责公司废气、废水、噪声、固体废弃物排放的监测。 4.4 总务部负责对环境目标、指标符合情况与环境法律法规遵守情况进行监测。 5 控制程序 5.1 环境表现的监测 5.1.1 能源使用情况的监测 设备总务部门按月检查公司水表与电表,对公司及相关部门水、电的 使用量记录于“水/电使用登记表”;总务部每月对公司纸张和燃料的 使用情况进行检查并记录于“纸张/燃料使用登记表”中。 5.1.2 固体废弃物排放的监测 总务部根据固体废弃物的处理情况,制定“固体废弃物排放监登记表”。 5.1.3 废气、废水、噪声的监测 公司排放气的废气、废水、噪声监测由总务部联络并委托具有相应废 气监测法律资质的第三方每一年监测一次,监测结果记录于第三方开 具的监测报告中。 5.2 运行控制的监测 5.2.1 总务部对公司各部门环境管理要求的运行情况每星期检查一次,检查 结果记录“环境巡检记录表”中。 5.2.2 管理者代表对公司各部门环境管理要求的运行情况进行不定期地检 查,检查结果记录于“环境巡检记录表”中。 5.3 目标与指标符合情况的监测 总务部对公司环境目标和指标的达成情况进行监测,监测记录于“目标与指 标达成监测记录表”中。 5.4 监测装置的控制 公司内部如有环境监测装置在使用的,则环境监测装置应按公司质量管理体 系中的相关文件进行定期地校准和检定,以确保监测结果的有效性。 5.5 监测的结果的处理 对公司所有环境监测与评价结果中(潜在)偏离相关目标、指标、标准或其它 文件要求,相关责任部门需按《纠正和预防措施控制程序》采取相应的预防 或纠正措施。 5.6 总务部每年至少组织一次相关部门对公司适用法律法规的符合情况进行综
行政案件制作笔录询问要点 一、吸毒案件之询问违法嫌疑人实体要素: 1、按照吸毒召集、实施、查获的顺序,让被询问人如实陈述吸毒过程,详细记录吸毒的时间、地点、参与人员、工具、毒品类型等要素。 2、上述陈述中未阐述清楚的或需重点查清的问题,可单独设问,查清以下情节: (1)毒品的品种、特征、数量、来源和余留部分的去向。 (2)吸食毒品的地点。 (3)吸食毒品的参与人员。 (4)吸食毒品的方式,吸食工具的特征、来源和去向。 (5)是否还有其他吸毒行为。 (6)第一次吸毒的时间和具体过程。 (7)最后一次吸毒的时间和具体过程。 (8)其他参与吸毒人员的基本情况。 (9)是否正在接受社区戒毒。 3、对于有违法现场的聚众吸食毒品案件,还应详细了解现场情况,并问清以下内容: (1)在现场的人员。 (2)参与吸食毒品的人员。 (3)能否辨认出吸食毒品的人。 (4)现场是否遗留毒品,毒品是如何摆放的。 (5)场所工作人员对吸毒行为是否明知。 (6)有否场所工作人员参与吸毒。 4、对于不承认吸毒的人,指出尿检阳性的结果与其陈述不符并听取辩解,对其辩解中自相矛盾的地方进行重点询问,迫使其不能自圆其说而交待吸毒事实。 5、对于交待吸毒地点不在本地区的,应询问其来杭(本地区)时间、方式等情况,对其陈述中自相矛盾的地方进行重点询问,以甄别其陈述的真伪,明确案件的管辖权。 6、被查获的时间、地点和过程等情况。 二、卖淫嫖娼案件之询问违法嫌疑人实体要素: 1、按照卖淫嫖娼双方结识、谈价、实施、查获的顺序,让被询问人如实陈述卖淫嫖娼过程,详细记录卖淫嫖娼的时间、地点、发生方式、嫖资等要素。 2、上述陈述中未阐述清楚的或需重点查清的问题,可单独设问,查清以下情节: (1)卖淫嫖娼双方结识的时间、地点和过程,谈价过程中如使用“玩、套餐”等“行业”用语的要问明实质上的意义。 (2)卖淫嫖娼情节。重点包括:卖淫嫖娼的时间、地点、发生的方式;若使用避孕套等工具的,问明特征、来源和去向;卖淫嫖娼是否既遂;嫖资的支付对象、方式等情况。 (3)卖淫、嫖娼人员是第几次卖淫、嫖娼,为什么进行卖淫嫖娼活动。 (4)卖淫嫌疑人是否以获取物质利益为目的。 (5)卖淫、嫖娼人员是否明知自己有性病。 (6)在公共场所、出租房内发生的卖淫嫖娼案件,应问明经营者、房东是否有组织、强迫、介绍、容留的故意,放任不管的过错;卖淫、嫖娼人员是否经人介绍认识,介绍人是否有物质利益上的获取(提成),介绍人在卖淫、嫖娼人员间的具体牵线搭桥行为。 (7)卖淫、嫖娼人员的体貌特征。对于一方不承认卖淫或者嫖娼的,尤其要详细询问私密性特征,如纹身、内衣内裤的颜色等。 (8)被查获的时间、地点和过程等情况。 (9)现场目击者、知情者以及其他情况。