WHO guidelines on transfer of technology in pharmaceutical manufacturing Annex 7_
?World Health Organization
WHO Technical Report Series, No. 961, 2011
Annex 7
WHO guidelines on transfer of technology
in pharmaceutical manufacturing
1. Intr o duct i on
2. Sc o pe
3. Gl o ssary
4. Organ i zat i on and management
5. Pr o duct i on: transfer (process i ng, packag i ng and clean i ng)
6. Qual i ty control: analyt i cal method transfer
7. Prem i ses and equ i pment
8. D o cumentat i on
9. Qual i? cat i on and val i dat i on
References
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1. Introduction
These gu i d i ng pr i nc i ples on transfer of technology are i ntended to serve as
a framework wh i ch can be appl i ed i n a ? ex i ble manner rather than as str i ct
r i g i d gu i dance. Focus has been placed on the qual i ty aspects, i n l i ne w i th WHO’s mandate.
1.1 Transfer of processes to an alternat i ve s i te occurs at some stage i n the
l i fe-cycle of most products, from development, scale-up, manufactur i ng, product i on and launch, to the post-approval phase.
1.2 Transfer of technology i s de? ned as “a log i cal procedure that controls
the transfer of any process together w i th i ts documentat i on and profess i onal expert i se between development and manufacture or between manufacture s i tes”. It i s a systemat i c procedure that i s followed i n order to pass the documented knowledge and exper i ence ga i ned dur i ng development and or commerc i al i zat i on to an appropr i ate, respons i ble and author i zed party.
Technology transfer embod i es both the transfer of documentat i on and the demonstrated ab i l i ty of the rece i v i ng un i t (RU) to effect i vely perform the cr i t i cal elements of the transferred technology, to the sat i sfact i on of all part i es and any appl i cable regulatory bod i es.
1.3 L i terature searches revealed l i ttle i nformat i on on the sub j ect or i g i nat i ng
from nat i onal or reg i onal regulatory b od i es. Gu i dance on i ntracompany transfers was prepared b y the Internat i onal Soc i ety for Pharmaceut i cal Eng i neer i ng (ISPE) (1).
1.4 The ever chang i ng bus i ness strateg i es of pharmaceut i cal compan i es
i ncreas i ngly i nvolve i ntra- and i ntercompany transfers of technology for
reasons such as the need for add i t i onal capac i ty, relocat i on of operat i ons or consol i dat i ons and mergers. The WHO Expert Comm i ttee on Spec i? cat i ons for Pharmaceut i cal Preparat i ons, therefore, recommended i n i ts forty-second report that WHO address th i s i ssue through preparat i on of WHO gu i del i nes on th i s matter (2).
1.5Transfer of technology requ i res a documented, planned approach us i ng
tra i ned and knowledgeable personnel work i ng w i th i n a qual i ty system, w i th documentat i on of data cover i ng all aspects of development, product i on and qual i ty control. Usually there i s a send i ng un i t (SU), a rece i v i ng un i t and the un i t manag i ng the process, wh i ch may or may not be a separate ent i ty. For “contract manufactur i ng” please see good manufactur i ng pract i ces (GMP) (3).
1.6 For the transfer to be successful, the follow i ng general pr i nc i ples and
requ i rements should be met:
?the pro j ect plan should encompass the qual i ty aspects of the pro j ect and be based upon the pr i nc i ples of qual i ty r i sk management;
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?the capab i l i t i es of the SU and at the RU should b e s i m i lar, b ut not necessar i ly i dent i cal, and fac i l i t i es and equ i pment should operate accord i ng to s i m i lar operat i ng pr i nc i ples;
? a comprehens i ve techn i cal gap analys i s between the SU and RU i nclud i ng
techn i cal r i sk assessment and potent i al regulatory gaps, should b e performed as needed;
?adequately tra i ned staff should be ava i lable or should be tra i ned at the RU:—regulatory requ i rements i n the countr i es of the SU and the RU, and
i n any countr i es where the product i s i ntended to be suppl i ed, should
b e taken i nto account and i nterpreted cons i stently throughout any
transfer programme pro j ect; and
—there should be effect i ve process and product knowledge transfer.
1.7Technology transfer can be cons i dered successful i f there i s documented
ev i dence that the RU can rout i nely reproduce the transferred product, process or method aga i nst a prede? ned set of spec i? cat i ons as agreed w i th the SU.
1.8 In the event that the RU i dent i? es part i cular problems w i th the process
dur i ng the transfer, the RU should commun i cate them back to the SU to ensure cont i nu i ng knowledge management.
1.9 Technology transfer pro j ects, part i cularly those b etween d i fferent
compan i es, have legal and econom i c i mpl i cat i ons. If such i ssues, wh i ch may i nclude i ntellectual property r i ghts, royalt i es, pr i c i ng, con?i ct of
i nterest and con? dent i al i ty, are expected to i mpact on open commun i cat i on
of techn i cal matters i n any way, they should be addressed before and dur i ng plann i ng and execut i on of the transfer.
1.10 Any lack of transparency may lead to i neffect i ve transfer of
technology.
1.11 Some of the pr i nc i ples outl i ned i n th i s document may also b e
appl i cab le to manufactur i ng i nvest i gat i onal pharmaceut i cal products for cl i n i cal tr i als as part of research and development, but th i s i s not the ma i n focus of th i s gu i dance and has been excluded due to the complex i ty of the processes.
1.12 Some of the respons i b i l i t i es outl i ned i n th i s document for the SU
may also be cons i dered to be part of the management un i t respons i b i l i t i es.
2. Scope
Note: Th i s sect i on spec i? cally prov i des for transfer of qual i ty control (QC) methods where a techn i cal agreement ex i sts (SU manufacturer to RU manufacturer or SU manufacturer to RU QC laboratory). Where no such techn i cal agreements ex i st (e.g. test i ng by nat i onal laborator i es or test i ng
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for procurement agenc i es) a number of the po i nts l i sted i n sect i on 2.4 may not be workable, and alternat i ve approaches may be requ i red.
2.1 Th i s document g i ves gu i dance i n pr i nc i ple and prov i des general
recommendat i ons on the act i v i t i es necessary to conduct a successful i ntra- or i nters i te transfer of technology as descr i bed i n the Introduct i on to these gu i del i nes. The i ntent i on i s to address the bas i c cons i derat i ons needed for
a successful transfer i n order to sat i sfy the regulatory author i ty de? ned for
the transfer process.
2.2 The gu i del i nes w i ll be appl i ed to manufactur i ng act i ve pharmaceut i cal
i ngred i ents (APIs), manufactur i ng and packag i ng of b ulk mater i als,
manufactur i ng and packag i ng of ? n i shed pharmaceut i cal products (FPPs) and/or perform i ng analyt i cal test i ng.
2.3 The recommendat i ons prov i ded i n these gu i del i nes apply to all dosage
forms but need to be ad j usted on a case-by-case bas i s (e.g. by us i ng r i sk management pr i nc i ples). Part i cularly close control of certa i n aspects w i ll be requ i red for certa i n formulat i ons such as ster i le products, and metered-dose aerosols. WHO gu i dance on manufacture of spec i? c pharmaceut i cal products(4,5) w i ll be useful i n th i s regard.
2.4 The gu i del i nes address the follow i ng areas at the SU and the RU:
—transfer of development and product i on (process i ng, packag i ng and clean i ng);
—transfer of analyt i cal methods for qual i ty assurance and qual i ty control;
—sk i lls assessment and tra i n i ng;
—organ i zat i on and management of the transfer;
—assessment of prem i ses and equ i pment;
—documentat i on; and
—qual i? cat i on and val i dat i on.
2.5Because each transfer pro j ect i s un i que, the prov i s i on of a comprehens i ve
set of gu i del i nes i s beyond the scope of th i s document.
2.6 These gu i del i nes do not prov i de gu i dance on any legal, ? nanc i al or
commerc i al cons i derat i ons assoc i ated w i th technology transfer pro j ects. 3. Glossary
The de? n i t i ons g i ven below apply to the terms used i n these gu i del i nes.
They may have d i fferent mean i ngs i n other contexts.
acceptance criteria
Measurable terms under wh i ch a test result w i ll be cons i dered acceptable. 288
active pharmaceutical ingredient (API)
Any sub stance or m i xture of sub stances i ntended to b e used i n the manufacture of a pharmaceut i cal dosage form and that, when so used, b ecomes an act i ve i ngred i ent of that pharmaceut i cal dosage form. Such substances are i ntended to furn i sh pharmacolog i cal act i v i ty or other d i rect effect i n the d i agnos i s, cure, m i t i gat i on, treatment, or prevent i on of d i sease or to affect the structure and funct i on of the body.
bracketing
An exper i mental des i gn to test only the extremes of, for example, dosage strength. The des i gn assumes that the extremes w i ll be representat i ve of all the samples between the extremes.
change control (C/C)
A formal system b y wh i ch qual i? ed representat i ves of appropr i ate d i sc i pl i nes rev i ew proposed or actual changes that m i ght affect a val i dated status. The i ntent i s to determ i ne the need for act i on that would ensure that the system i s ma i nta i ned i n a val i dated state.
commissioning
The sett i ng up, ad j ustment and test i ng of equ i pment or a system to ensure that i t meets all the requ i rements, as spec i? ed i n the user requ i rement spec i? cat i on, and capac i t i es as spec i?ed b y the des i gner or developer. Comm i ss i on i ng i s carr i ed out before qual i? cat i on and val i dat i on.
control strategy
A planned set of controls, der i ved from current product and process understand i ng, that assures process performance and product qual i ty. The controls can i nclude parameters and attr i b utes related tomater i als and components related to drug sub stances and drug product mater i als and components, fac i l i ty and equ i pment operat i ng cond i t i ons, i n-process controls, ? n i shed product spec i? cat i ons, and the assoc i ated methods and frequency of mon i tor i ng and control (6).
corrective action (C/A)
Any act i on to be taken when the results of mon i tor i ng at a cr i t i cal control po i nt i nd i cate a loss of control.
critical
Hav i ng the potent i al to i mpact on product qual i ty or performance i n a s i gn i? cant way.
critical control point (CCP)
A step at wh i ch control can be appl i ed and i s essent i al to prevent or el i m i nate a pharmaceut i cal qual i ty hazard or to reduce i t to an acceptable level.
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design quali? cation (DQ)
Documented ev i dence that the prem i ses, support i ng systems, ut i l i t i es, equ i pment and processes have b een des i gned i n accordance w i th the requ i rements of good manufactur i ng pract i ces (GMP).
design space
The mult i d i mens i onal comb i nat i on and i nteract i on of i nput var i ables (e.g.
mater i al attr i butes) and process parameters that have been demonstrated to prov i de assurance of qual i ty (7).
drug master ? le (DMF)
Deta i led i nformat i on concern i ng a spec i? c fac i l i ty, process or product subm i tted to the med i c i nes regulatory author i ty, i ntended for i ncorporat i on
i nto the appl i cat i on for market i ng author i zat i on.
? nished pharmaceutical product (FPP)
A product that has undergone all stages of product i on, i nclud i ng packag i ng
i n i ts ? nal conta i ner and labell i ng. An FPP may conta i n one or more APIs.
gap analysis
Ident i? cat i on of cr i t i cal elements of a process wh i ch are ava i lable at the SU but are m i ss i ng from the RU.
good manufacturing practices (GMP)
That part of qual i ty assurance wh i ch ensures that pharmaceut i cal products are cons i stently produced and controlled to the qual i ty standards appropr i ate to the i r i ntended use and as requ i red by the market i ng author i zat i on (3).
in-process control (IPC)
Checks performed dur i ng product i on i n order to mon i tor and, i f necessary, to ad j ust the process to ensure that the product conforms to i ts spec i? cat i ons.
The control of the env i ronment or equ i pment may also be regarded as a part of i n-process control.
installation quali? cation (IQ)
The performance of tests to ensure that the i nstallat i ons (such as mach i nes, measur i ng dev i ces, ut i l i t i es and manufactur i ng areas) used i n
a manufactur i ng process are appropr i ately selected and correctly i nstalled
and operate i n accordance w i th establ i shed spec i? cat i ons.
intercompany transfer
A transfer of technology between s i tes of d i fferent compan i es.
intracompany transfer
A transfer of technology between s i tes of the same group of compan i es.
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operational quali? cation (OQ)
Documented ver i? cat i on that the system or subsystem performs as i ntended over all ant i c i pated operat i ng ranges.
performance quali? cation (PQ)
Documented ver i? cat i on that the equ i pment or system operates cons i stently and g i ves reproduc i b i l i ty w i th i n de? ned spec i? cat i ons and parameters for prolonged per i ods. (In the context of systems, the term “process val i dat i on”may also be used.)
process validation
Documented ev i dence wh i ch prov i des a h i gh degree of assurance that a spec i?c process w i ll cons i stently result i n a product that meets i ts predeterm i ned spec i? cat i ons and qual i ty character i st i cs.
quali? cation
Act i on of prov i ng and document i ng that any prem i ses, systems and equ i pment are properly i nstalled, and/or work correctly and lead to the expected results. Qual i? cat i on i s often a part (the i n i t i al stage) of val i dat i on, but the i nd i v i dual qual i? cat i on steps alone do not const i tute process val i dat i on.
quali? cation batches
Those batches produced by the RU to demonstrate i ts ab i l i ty to reproduce the product (1).
quality assurance (QA)
Qual i ty assurance i s a w i de-rang i ng concept cover i ng all matters that i nd i v i dually or collect i vely i n?uence the qual i ty of a product.It i s the total i ty of the arrangements made w i th the ob j ect i ve of ensur i ng that pharmaceut i cal products are of the qual i ty requ i red for the i r i ntended use. quality control (QC)
Qual i ty control covers all measures taken, i nclud i ng the sett i ng of spec i? cat i ons, sampl i ng, test i ng and analyt i cal clearance, to ensure that start i ng mater i als, i ntermed i ates, packag i ng mater i als and ? n i shed pharmaceut i cal products conform w i th establ i shed spec i? cat i ons for i dent i ty, strength, pur i ty and other character i st i cs.
quality planning
Part of qual i ty management focused on sett i ng qual i ty ob j ect i ves and spec i fy i ng necessary operat i onal processes and related resources to ful? l the qual i ty ob j ect i ves (6).
quality policy
Overall i ntent i ons and d i rect i on of an organ i zat i on related to qual i ty as formally expressed by sen i or management (6).
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quality risk management (QRM)
Qual i ty r i sk management i s a systemat i c process for the assessment, control, commun i cat i on and rev i ew of r i sks to the qual i ty of the pharmaceut i cal product throughout the product l i fe-cycle.
receiving unit (RU)
The i nvolved d i sc i pl i nes at an organ i zat i on where a des i gnated product, process or method i s expected to be transferred.
sending unit (SU)
The i nvolved d i sc i pl i nes at an organ i zat i on from where a des i gnated product, process or method i s expected to be transferred.
spiking
The add i t i on of a known amount of a compound to a standard, sample or placeb o, typ i cally for the purpose of con? rm i ng the performance of an analyt i cal procedure.
standard operating procedure (SOP)
An author i zed wr i tten procedure g i v i ng i nstruct i ons for perform i ng operat i ons not necessar i ly spec i? c to a g i ven product or mater i al (e.g.
equ i pment operat i on, ma i ntenance and clean i ng, val i dat i on, clean i ng of prem i ses and env i ronmental control, sampl i ng and i nspect i on). Certa i n SOPs may b e used to supplement product-spec i?c master and b atch product i on documentat i on.
technology transfer report
A documented summary of a spec i? c technology transfer pro j ect l i st i ng
procedures, acceptance cr i ter i a, results ach i eved and conclus i ons. Any dev i at i on should be d i scussed and j ust i? ed.
validation
Act i on of prov i ng and document i ng that any process, procedure or method actually and cons i stently leads to the expected results.
validation master plan (VMP)
A h i gh-level document that establ i shes an umbrella val i dat i on plan for the
ent i re pro j ect and summar i zes the manufacturer’s overall ph i losophy and approach, to be used for establ i sh i ng performance adequacy. It prov i des
i nformat i on on the manufacturer’s val i dat i on work programme and
de? nes deta i ls of and t i mescales for the val i dat i on work to be performed,
i nclud i ng a statement of the respons i b i l i t i es of those i mplement i ng the
plan.
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validation protocol (or plan) (VP)
A document descr i b i ng the act i v i t i es to b e performed i n a val i dat i on,
i nclud i ng the acceptance cr i ter i a for the approval of a manufactur i ng
process — or a part thereof — for rout i ne use.
validation report (VR)
A document i n wh i ch the records, results and evaluat i on of a completed
val i dat i on programme are assembled and summar i zed. It may also conta i n proposals for the i mprovement of processes and or equ i pment.
n and management
4. Organizatio
4.1 Transfer compr i ses an SU and an RU. In some c i rcumstances there
may be an add i t i onal un i t wh i ch w i ll be respons i ble for d i rect i ng, manag i ng and approv i ng the transfer.
4.2 There i s a formal agreement between the part i es, wh i ch spec i? es the
respons i b i l i t i es before, dur i ng and after transfer.
4.3 Organ i zat i on and management of a successful technology transfer
need to ensure that the ma i n steps have been executed and documented as descr i bed i n sect i on 1.6.
4.4There should b e a pro j ect management plan wh i ch i dent i? es
and controls all the necessary act i v i t i es i dent i?ed at the start of the undertak i ng.
4.5 The transfer protocol should l i st the i ntended sequent i al stages of the
transfer. The protocol should i nclude:
—ob j ect i ve;
—scope;
—key personnel and the i r respons i b i l i t i es;
—a parallel compar i son of mater i als, methods and equ i pment;
—the transfer stages w i th documented ev i dence that each cr i t i cal stage has been sat i sfactor i ly accompl i shed before the next commences;
—i dent i? cat i on of cr i t i cal control po i nts;
—exper i mental des i gn and acceptance cr i ter i a for analyt i cal methods;
—i nformat i on on tr i al product i on b atches, qual i? cat i on b atches and process val i dat i on;
—change control for any process dev i at i ons encountered;
—assessment of end-product;
—arrangements for keep i ng retent i on samples of act i ve i ngred i ents,
i ntermed i ates and ? n i shed products, and i nformat i on on reference
substances where appl i cable; and
—conclus i on, i nclud i ng s i gned-off approval by pro j ect manager.
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4.6 The SU should prov i de the necessary val i dat i on documentat i on for
the process and i ts support funct i ons. Usually, an estab l i shed process i s transferred, and such documentat i on i s already ava i lable.
4.7 The SU should prov i de cr i ter i a and i nformat i on on hazards and
cr i t i cal steps assoc i ated w i th the product, process or method to b e transferred, to serve as a b as i s for a qual i ty r i sk management (QRM) exerc i se at the RU (7–10).
4.8 The SU or th i rd party should assess the su i tab i l i ty and degree of
preparedness of the RU before transfer, w i th regard to prem i ses, equ i pment and support serv i ces (e.g. purchas i ng and i nventory control mechan i sms, qual i ty control (QC) procedures, documentat i on, computer val i dat i on, s i te val i dat i on, equ i pment qual i? cat i on, water for pharmaceut i cal product i on and waste management).
4.9The SU and the RU should j o i ntly ver i fy that the follow i ng,
sat i sfactor i ly completed, val i dat i on protocols are ava i lable:
?i nstallat i on qual i? cat i on (IQ) and operat i onal qual i? cat i on (OQ) data for
manufactur i ng and packag i ng equ i pment at the RU s i te and analyt i cal
equ i pment; and
?qual i? cat i on of the rooms for both manufacture and packag i ng at the RU
s i te.
4.10The SU and the RU should j o i ntly i mplement any tra i n i ng
programmes that may b e requ i red spec i?c to the product, process or method to be transferred, e.g. on analyt i cal methods or equ i pment usage, and assess tra i n i ng outcomes.
4.11 The SU and the RU should j o i ntly execute the transfer protocol
accord i ng to a checkl i st and or ? ow d i agram show i ng the sequence of steps to be carr i ed out to effect an ef? c i ent transfer.
4.12 Any changes and adaptat i ons made dur i ng the course of the
technology transfer should be fully documented.
4.13 The SU and the RU should j o i ntly document the execut i on of the
transfer protocol i n a transfer of technology summary i n a report.
team
Project
4.14 Any transfer pro j ect w i ll be managed by a team compr i s i ng members
w i th clearly de? ned key respons i b i l i t i es. The team should be drawn from members of relevant d i sc i pl i nes from both the SU and RU s i tes.
4.15 The team memb ers should have the necessary qual i? cat i ons and
exper i ence to manage the i r part i cular aspect of the transfer.
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5.Production: transfer (processing, packaging
and cleaning)
5.1 The RU should b e ab le to accommodate the i ntended product i on
capac i ty. If poss i ble, i t should b e estab l i shed at the outset whether the
i ntent i on i s to perform s i ngle-batch manufacture, cont i nuous product i on or
campa i gns.
5.2 Cons i derat i on should be g i ven to the level and depth of deta i l to be
transferred to support product i on and any further process development and opt i m i zat i on at the RU as i ntended under the transfer pro j ect plan.
5.3 Cons i derat i on should b e g i ven to the techn i cal expert i se, s i te
technology and s i te capab i l i t i es for the RU. It should be i dent i? ed upfront by the SU of any process robustness i ssues so that plans may be put i n place at the RU.
5.4 The SU and the RU should j o i ntly develop a protocol for the transfer
of relevant i nformat i on related to the process under cons i derat i on from the SU to the RU, as well as the development of a comparable process at the RU.
materials
Starting
5.5 The spec i? cat i ons and relevant funct i onal character i st i cs of the
start i ng mater i als (APIs and exc i p i ents) (11,12) to be used at the RU should be cons i stent w i th mater i als used at the SU. Any propert i es wh i ch are l i kely to i n? uence the process or product should be i dent i? ed and character i zed.
Active pharmaceutical ingredients (API)
5.6 The SU should prov i de the RU w i th the open (appl i cant’s) part
of the API master ?le (APIMF or drug master ?le (DMF) or act i ve substance master ? le (ASMF)), or equ i valent i nformat i on and any relevant add i t i onal i nformat i on on the API of i mportance for the manufacture of the pharmaceut i cal product. The follow i ng are examples of the i nformat i on wh i ch may typ i cally be prov i ded; however the i nformat i on needed i n each spec i? c case should be assessed us i ng the pr i nc i ples of QRM:
?manufacturer and assoc i ated supply cha i n;
?step of the API to be transferred;
?? ow chart of synthes i s pathway, outl i n i ng the process, i nclud i ng entry po i nts for raw mater i als, cr i t i cal steps, process controls and i ntermed i ates;
?where relevant, de? n i t i ve phys i cal form of the API (i nclud i ng
photom i crographs and other relevant data) and any polymorph i c and solvate forms;
?solub i l i ty pro? le;
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?i f relevant, pH i n solut i on;
?part i t i on coef? c i ent, i nclud i ng the method of determ i nat i on;
?i ntr i ns i c d i ssolut i on rate, i nclud i ng the method of determ i nat i on;
?part i cle s i ze and d i str i but i on, i nclud i ng the method of determ i nat i on;
?bulk phys i cal propert i es, i nclud i ng data on bulk and tap dens i ty, surface
area and poros i ty as appropr i ate;
?water content and determ i nat i on of hygroscop i c i ty, i nclud i ng water act i v i ty data and spec i al handl i ng requ i rements;
?m i crob i olog i cal cons i derat i ons (i nclud i ng ster i l i ty, bacter i al endotox i ns
and b i ob urden levels where the API supports m i crob i olog i cal growth)
i n accordance w i th nat i onal, reg i onal or i nternat i onal pharmacopoe i al
requ i rements;
?spec i? cat i ons and j ust i? cat i on for release and end-of-l i fe l i m i ts;
?summary of stab i l i ty stud i es conducted i n conform i ty w i th current gu i del i nes, i nclud i ng conclus i ons and recommendat i ons on retest date;
?l i st of potent i al and observed synthet i c i mpur i t i es, w i th data to support
proposed spec i? cat i ons and typ i cally observed levels;
?i nformat i on on degradants, w i th a l i st of potent i al and ob served degradat i on products and data to support proposed spec i? cat i ons and
typ i cally observed levels;
?potency factor, i nd i cat i ng ob served pur i ty and j ust i? cat i on for any recommended ad j ustment to the i nput quant i ty of API for product manufactur i ng, prov i d i ng example calculat i ons; and
?spec i al cons i derat i ons w i th i mpl i cat i ons for storage and or handl i ng,
i nclud i ng b ut not l i m i ted to safety and env i ronmental factors (e.g. as
spec i? ed i n mater i al safety data sheets) and sens i t i v i ty to heat, l i ght or
mo i sture.
Excipients
5.7 The exc i p i ents (11) to be used have a potent i al i mpact on the ? nal
product. The i r spec i? cat i ons and relevant funct i onal character i st i cs should, therefore, b e made ava i lab le b y the SU for transfer to the RU s i te. The follow i ng are examples of the i nformat i on wh i ch may typ i cally be prov i ded;
however, the i nformat i on needed i n each spec i? c case should be assessed us i ng the pr i nc i ples of QRM:
?manufacturer and assoc i ated supply cha i n;
?descr i pt i on of funct i onal i ty, w i th j ust i? cat i on for i nclus i on of any ant i ox i dant, preservat i ve or any exc i p i ent;
?de? n i t i ve form (part i cularly for sol i d and i nhaled dosage forms);
?solub i l i ty pro? le (part i cularly for i nhaled and transdermal dosage forms);
?part i t i on coef? c i ent, i nclud i ng the method of determ i nat i on (for transdermal dosage forms);
296
?i ntr i ns i c d i ssolut i on rate, i nclud i ng the method of determ i nat i on (for transdermal dosage forms);
?part i cle s i ze and d i str i but i on, i nclud i ng the method of determ i nat i on (for sol i d, i nhaled and transdermal dosage forms);
?bulk phys i cal propert i es, i nclud i ng data on bulk and tap dens i ty, surface area and poros i ty as appropr i ate (for sol i d and i nhaled dosage forms);?compact i on propert i es (for sol i d dosage forms);
?melt i ng po i nt range (for sem i-sol i d or top i cal dosage forms);
?pH range (for parenteral, sem i-sol i d or top i cal, l i qu i d and transdermal dosage forms);
?i on i c strength (for parenteral dosage forms);
?spec i? c dens i ty or grav i ty (for parenteral, sem i-sol i d or top i cal, l i qu i d and transdermal dosage forms);
?v i scos i ty and or v i scoelast i c i ty (for parenteral, sem i-sol i d or top i cal, l i qu i d and transdermal dosage forms);
?osmolar i ty (for parenteral dosage forms);
?water content and determ i nat i on of hygroscop i c i ty, i nclud i ng water act i v i ty data and spec i al handl i ng requ i rements (for sol i d and i nhaled dosage forms);
?mo i sture content range (for parenteral, sem i sol i d or top i cal, l i qu i d and transdermal dosage forms);
?m i crob i olog i cal cons i derat i ons (i nclud i ng ster i l i ty, bacter i al endotox i ns and b i ob urden levels where the exc i p i ent supports m i crob i olog i cal growth) i n accordance w i th nat i onal, reg i onal or i nternat i onal pharmacopoe i al requ i rements, as appl i cable (for general and spec i? c monographs);?spec i? cat i ons and j ust i? cat i on for release and end-of-l i fe l i m i ts;
?i nformat i on on adhes i ves support i ng compl i ance w i th peel, sheer and adhes i on des i gn cr i ter i a (for transdermal dosage forms);
?spec i al cons i derat i ons w i th i mpl i cat i ons for storage and or handl i ng, i nclud i ng b ut not l i m i ted to safety and env i ronmental factors (e.g. as spec i? ed i n mater i al safety data sheets (MSDS)) and sens i t i v i ty to heat, l i ght or mo i sture; and
?regulatory cons i derat i ons, e.g. documentat i on to support compl i ance w i th transm i ss i le an i mal spong i form encephalopathy cert i? cat i on requ i rements (where appl i cable).
Information on process and ? nished pharmaceutical
products information
5.8 The SU should prov i de a deta i led character i zat i on of the product,
i nclud i ng i ts qual i tat i ve and quant i tat i ve compos i t i on, phys i cal descr i pt i on, method of manufacture, i n-process controls, control method and spec i? cat i ons, packag i ng components and con? gurat i ons, and any safety and handl i ng cons i derat i ons.
297
5.9 The SU should prov i de any i nformat i on on the h i story of process
development wh i ch may b e requ i red to enab le the RU to perform any further development and or process opt i m i zat i on after successful transfer.
Such i nformat i on may i nclude the follow i ng:
?i nformat i on on cl i n i cal development, e.g.i nformat i on on the rat i onale for
the synthes i s, route and form select i on, technology select i on, equ i pment,
cl i n i cal tests, and product compos i t i on;
?i nformat i on on scale-up act i v i t i es: process opt i m i zat i on, stat i st i cal
opt i m i zat i on of cr i t i cal process parameters, cr i t i cal qual i ty attr i butes,
p i lot report and or i nformat i on on p i lot-scale development act i v i t i es
i nd i cat i ng the number and d i spos i t i on of batches manufactured;
?i nformat i on or report on full-scale development act i v i t i es, i nd i cat i ng
the number and d i spos i t i on of batches manufactured, and dev i at i on and
change control (somet i mes referred to as change management) reports
wh i ch led to the current manufactur i ng process;
?the change h i story and reasons, e.g. a change control log, i nd i cat i ng any
changes to the process or pr i mary packag i ng or analyt i cal methods as a
part of process opt i m i zat i on or i mprovement; and
?i nformat i on on i nvest i gat i ons of prob lems and the outcomes of the
i nvest i gat i ons.
5.10 The SU should prov i de to the RU i nformat i on on any health, safety
and env i ronmental i ssues assoc i ated w i th the manufactur i ng processes to
b e transferred, and the i mpl i cat i ons, e.g. need for gown i ng or protect i ve
cloth i ng.
5.11 The SU should prov i de to the RU i nformat i on on current process i ng
and test i ng, i nclud i ng but not l i m i ted to:
? a deta i led descr i pt i on of fac i l i ty requ i rements and equ i pment;
?i nformat i on on start i ng mater i als, appl i cab le MSDS and storage requ i rements for raw mater i als and ? n i shed products;
?descr i pt i on of manufactur i ng steps (narrat i ve and process maps or ? ow charts, and or master batch records), i nclud i ng qual i? cat i on of i n-
process i ng hold t i mes and cond i t i ons, order and method of raw mater i al
add i t i on and bulk transfers between process i ng steps;
?descr i pt i on of analyt i cal methods;
?i dent i? cat i on and j ust i? cat i on of control strategy (e.g.i dent i? cat i on of cr i t i cal performance aspects for spec i?c dosage forms, i dent i? cat i on of
process control po i nts, product qual i ty attr i butes and qual i? cat i on of cr i t i cal
process i ng parameter ranges, stat i st i cal process control (SPC) charts);
?des i gn space, i n cases where th i s has been de? ned;
?val i dat i on i nformat i on, e.g. val i dat i on plans and reports;
?annual product qual i ty rev i ews;
298
?stab i l i ty i nformat i on;
?an author i zed set of protocols and work i nstruct i ons for manufactur i ng; and ?env i ronmental cond i t i ons or any spec i al requ i rement needed for the fac i l i ty or equ i pment depend i ng on the nature of the product to b e transferred.
5.12 Dur i ng the transfer process, the RU should i dent i fy any d i fferences
i n fac i l i t i es, systems and capab i l i t i es and commun i cate w i th the SU about
these d i fferences to understand the potent i al i mpact on ab i l i ty to run the process to del i ver good product qual i ty. D i fferences should be understood and sat i sfactor i ly addressed to assure equ i valent product qual i ty. Based on the i nformat i on rece i ved from the SU, the RU should cons i der i ts own capab i l i ty to manufacture and pack the product to the requ i red standards and should develop relevant plant operat i ng procedures and documentat i on
b efore the start of product i on. Process development at the RU should
address the follow i ng tasks:
?compar i son and assessment of su i tab i l i ty and qual i? cat i on of fac i l i ty and
equ i pment;
?descr i pt i on of manufactur i ng process and ?ow of personnel and of mater i als at the RU (narrat i ve and or process maps or ? ow charts);
?determ i nat i on of cr i t i cal steps i n manufacture, i nclud i ng hold t i mes, end-
po i nts, sampl i ng po i nts and sampl i ng techn i ques (13);
?wr i t i ng and approval of SOPs for all product i on operat i ons (e.g.d i spens i ng,
granulat i on or blend i ng or solut i on preparat i on, tablet compress i on, tablet
coat i ng, encapsulat i on, l i qu i d ? ll i ng, pr i mary and secondary packag i ng
and i n-process qual i ty control), packag i ng, clean i ng, test i ng and storage;
?evaluat i on of stab i l i ty i nformat i on, w i th generat i on of s i te-spec i? c
stab i l i ty data i f requ i red (14); and
?compl i ance w i th regulatory requ i rements for any changes made, e.g.i n
terms of batch s i ze.
Packaging
5.13 The transfer of packag i ng operat i ons should follow the same
procedural patterns as those of the product i on transfer.
5.14 Informat i on on packag i ng to be transferred from the SU to the RU
i ncludes spec i? cat i ons for a su i table conta i ner or closure system, as well
as any relevant add i t i onal i nformat i on on des i gn, pack i ng, process i ng or labell i ng requ i rements and tamper-ev i dent and ant i-counterfe i t i ng measures needed for qual i? cat i on of packag i ng components at the RU.
5.15 For QC test i ng of packag i ng components, spec i? cat i ons should be
prov i ded for draw i ngs, artwork and mater i al (for example, glass, card or ? bre board).
299
5.16 Based on the i nformat i on prov i ded, the RU should perform a
su i tab i l i ty study for i n i t i al qual i? cat i on of the packag i ng components.
Packag i ng i s cons i dered su i table i f i t prov i des adequate protect i on (prevent i ng degradat i on of the med i c i nedue to env i ronmental i n? uences), safety (ab sence of undes i rab le sub stances released i nto the product), compat i b i l i ty (absence of i nteract i on poss i bly affect i ng med i c i ne qual i ty) and performance (funct i onal i ty i n terms of drug del i very).
Cleaning
5.17 Dur i ng the manufactur i ng process, pharmaceut i cal products and
APIs can be contam i nated by other pharmaceut i cal products or APIs i f the plant i s process i ng d i fferent products. To m i n i m i ze the r i sk of contam i nat i on and cross-contam i nat i on, operator exposure and env i ronmental effects, adequate clean i ng procedures are essent i al.
5.18Clean i ng procedures and the i r val i dat i on are s i te-spec i? c. In order for
the RU to de? ne i ts clean i ng strategy the SU should prov i de i nformat i on on clean i ng at the SU to m i n i m i ze cross-contam i nat i on due to res i dues from prev i ous manufactur i ng steps, operator exposure and env i ronmental i mpact, i nclud i ng:
—i nformat i on on solub i l i ty of act i ve i ngred i ents, exc i p i ents and veh i cles;
—m i n i mum therapeut i c doses of act i ve i ngred i ents;
—therapeut i c category and tox i colog i cal assessment; and
—ex i st i ng clean i ng procedures.
Add i t i onal i nformat i on should be prov i ded, as appropr i ate and where ava i lable, e.g.:—clean i ng val i dat i on reports (chem i cal and m i crob i olog i cal);
—i nformat i on on clean i ng agents used (ef? cacy, ev i dence that they do not
i nterfere w i th analyt i cal test i ng for res i dues of APIs, removal of res i dual
clean i ng agents); and
—recovery stud i es to val i date the sampl i ng methodology.
5.19 Before the transfer, the SU should prov i de i nformat i on on l i m i ts for
product res i dues, and the rat i onale for l i m i t select i on.
5.20 Based on the i nformat i on prov i ded by the SU, clean i ng procedures
should be des i gned at the RU, tak i ng i nto account relevant character i st i cs of the start i ng mater i als (e.g. potency, tox i c i ty, solub i l i ty, corros i veness and temperature sens i t i v i ty), manufactur i ng equ i pment des i gn and con? gurat i on, clean i ng agent and products res i due.
Implementation of processing, packaging and cleaning systems
5.21 Tr i al batch(es) (“demonstrat i on batches”) are normally produced to
con? rm process capab i l i ty before i n i t i at i ng formal val i dat i on. Where tr i al 300
batches are produced, at a m i n i mum, all cr i t i cal process i ng parameters and ? n i shed product spec i? cat i ons should be assessed.
5.22 Once process capab i l i ty has been establ i shed at the RU, assur i ng that
the product, process or method at the RU meets prede? ned and j ust i? ed spec i? cat i ons, process val i dat i on and clean i ng val i dat i on can be carr i ed out.
o ntrol: analytical method transfer
6. Quality c
6.1 Transfer of analyt i cal methods should accommodate all the analyt i cal
test i ng requ i red to demonstrate compl i ance of the product to be transferred w i th the reg i stered spec i? cat i on (15).
6.2 Analyt i cal methods used to test pharmaceut i cal products, start i ng
mater i als, packag i ng components and clean i ng (res i due) samples, i f appl i cable, should be i mplemented at the test i ng laboratory before test i ng of samples for process val i dat i on stud i es i s performed by the RU. Process val i dat i on samples may be tested at the RU, the SU or a th i rd laboratory.
6.3 A protocol de? n i ng the steps should b e prepared for transfer of
analyt i cal methods. The analyt i cal methods transfer protocol should i nclude
a descr i pt i on of the o
b j ect i ve, scope and respons i b i l i t i es of the SU and the
RU; a spec i? cat i on of mater i als and methods; the exper i mental des i gn and acceptance cr i ter i a; documentat i on (i nclud i ng i nformat i on to be suppl i ed w i th the results, and report forms to b e used, i f any); procedure for the handl i ng of dev i at i ons; references; s i gned approval; and deta i ls of reference samples (start i ng mater i als, i ntermed i ates and ? n i shed products).
6.4 The SU’s respons i b i l i t i es for the transfer of analyt i cal methods are to:
?prov i de method-spec i? c tra i n i ng for analysts and other qual i ty control staff, i f requ i red;
?ass i st i n analys i s of QC test i ng results;
?de? ne all methods to be transferred for test i ng a g i ven product, start i ng mater i al or clean i ng sample;
?de? ne exper i mental des i gn, sampl i ng methods and acceptance cr i ter i a;
?prov i de any val i dat i on reports for methods under transfer and demonstrate
the i r robustness;
?prov i de deta i ls of the equ i pment used, as necessary (part of val i dat i on report, i f ava i lable) and any standard reference samples;
?prov i de approved procedures used i n test i ng; and
?rev i ew and approve transfer reports.
6.5 The RU’s respons i b i l i t i es are to:
?rev i ew analyt i cal methods prov i ded by the SU, and formally agree on acceptance cr i ter i a before execut i on of the transfer protocol;
301
302
?ensure that the necessary equ i pment for QC i s ava i lable and qual i ? ed at the RU s i te . The equ i pment used by the RU dur i ng the analyt i cal transfer should meet appropr i ate spec i ? cat i ons to ensure the requ i rements of the method or spec i ? cat i on are met ;
?ensure that adequately tra i ned and exper i enced personnel are i n place for analyt i cal test i ng ;
?prov i de a documentat i on system capable of record i ng rece i pt and test i ng of samples to the requ i red spec i ? cat i on us i ng approved test methods, and of report i ng, record i ng and collat i ng data and des i gnat i on of status (approved, re j ected, quarant i ne);
?execute the transfer protocol ;
?perform the appropr i ate level of val i dat i on to support the i mplementat i on of the methods ; and
?generate and obta i n approval of transfer reports .
6.6 Appropr i ate tra i n i ng should be prov i ded and all tra i n i ng act i v i t i es and outcomes should be documented .
6.7 Reference to compend i al monographs (e .g . The International Pharmacopoeia (15),European Pharmacopoeia ,British Pharmacopoeia and United States Pharmacopeia ), where ava i lable, i s expected .
6.8 Poss i ble exper i mental des i gns and acceptance cr i ter i a for the ma i n analyt i cal test i ng methods are shown i n Tab le 1. Note that th i s tab le represents h i gh-level gu i dance to apply the general pr i nc i ple that method transfers should account for the var i ab i l i ty and sens i t i v i ty of the method and the spec i ? cat i ons for the qual i ty parameter . Alternat i ve procedures and acceptance cr i ter i a may be appl i ed based on sc i ence and the character i st i cs of the analyt i cal method and the analyte .
T able 1
Possible experimental designs and acceptance criteria for analytical testing Test Considerations for transfer Replication
of tests Set-up Acceptance criteria Direct Statistically
derived
Identity Transfer should focus on sample prepara t ion,instruments, data interpretation.Acceptable to
include in assay
transfer where
relevant
One determina-
tion usually
suf? cient to
demonstrate
equivalence
for transfer of tests
Direct Statistically
derived
Assay for potency – N on-speci? c
assay should
not be used for
stability testing.
–Bracketing may
be appropri-
ate for multiple
strengths
At each site:
2 analysts
× 3 lots, in
triplicate
(= 18 per site)
Different sets
of instruments
and columns
Independent
solution pre-
paration
Comparison
of mean and
variability
Two one-
sided t-tests
with intersite
differences
≤ 2% , 95%
con? dence
Content uniformity If method is
equivalent to
assay method,
separate transfer
is not usually
requird
At each site:
2 analysts,
× 1 lot
(= 2 per site)
Different sets
of instruments
and columns
Independent
solution
preparation
Mean at RU
within ± 3%
of mean at
SU; compari-
son of relative
st. dev.
Two one-
sided t-tests
with intersite
differences
≤ 3% , 95%
con? dence
Dissolution Bracketing may
be appropri-
ate for multiple
strengths 6 units
(12 if not
routine at RU,
and for ex-
tended release
products)
Mean at RU
within ± 5%
of mean
at SU
Compare
pro? le
(e.g. F2), or
Compare
data at Q
time points
as for assay
Cleaning
veri? ca t ion (re c overy of residues from surfaces)Con? rm that
same swabbing
material is used
at sending unit
(SU) and
receiving unit
(RU)
Use spiked
samples,
with levels
within 3×
validated st.
dev. or within
± 10% of
speci? cation
(whichever is
the greater)
–All samples
spiked above
speci? cation
should fail
–90% of
samples
spiked
below spe-
ci? cation
should pass
Micro-biological testing (qualitative and quanti-tative limit tests)–Execute com-
mon on-site
validation pro-
tocol: rationale;
method iden-
tity; validation
parameters;
data summary;
acceptance cri-
teria; methods
of compiling
and analysing
data; handling
of out-of-speci-
? cation results;
follow-up
requirements
–Use same ma-
terials, techni-
ques, inocu l um
preparation
Validation in
triplicate
Use different
lots for each
validation
exercise
–Qualitative:
Demon-
strate
recovery
of micro-
organisms
–Quan-
titative:
Recovery
levels within
acceptance
limits
speci? ed in
protocol
303
for transfer of tests
Direct Statistically
derived
Impurity, degrada-tion, residu-al solvents –Con? rm re-
sponse factors
for calcula t ion
relative to drug
peak;
–Con? rm limit
of quantitation
at RU;
–Compare
chroma t o-
grams
–Compare
accuracy and
precision for
spiking experi-
ments
At each site:
2 analysts × 3
lots,
in duplicate
(in triplicate if
done together
with assay)
–Different
days,
different
sets of
instru-
ments and
columns
–Use
samples of
similar age,
homogene-
ity, packag-
ing, storage
–Use spiked
samples if
necessary
(For low
levels) Values
at RU within
± 25% of
values at SU,
or Mean at
RU within ±
0.05%
of mean at
SU (5%)
(For moder-
ately high lev-
els) Two one-
sided t-tests,
differences
≤ 10%, 95%
con? dence
st. dev., standard deviation.
Note: numbers in the table are given as examples only and should not be considered as recommendations.
The SU and the RU should execute the transfer protocol and j o i ntly prepare
a transfer report. The po i nts to
b e addressed i n the analyt i cal methods
transfer report are l i sted i n these gu i del i nes.
7.Premises and equipment
Premises
7.1 The SU s hould prov i de i nformat i on to the RU on the layout, construct i on
and ? n i sh of bu i ld i ngs and serv i ces (16,17) (heat i ng, vent i lat i on and a i r-cond i t i on i ng (HV AC), temperature, relat i ve hum i d i ty, water, power, and compressed a i r), wh i ch have an i mpact on the product, process or method to be transferred.
7.2 The SU should prov i de i nformat i on on relevant health, safety and
env i ronmental i ssues, i nclud i ng:
?i nherent r i sks of the manufactur i ng processes (e.g. react i ve chem i cal hazards, exposure l i m i ts, ? re and explos i on r i sks);
?health and safety requ i rements to m i n i m i ze operator exposure (e.g.
atmospher i c conta i nment of pharmaceut i cal dust);
?emergency plann i ng cons i derat i ons (e.g.i n case of gas or dust release, sp i llage, ? re and ? rewater run-off); and
?i dent i? cat i on of waste streams and prov i s i ons for re-use, recycl i ng and/
or d i sposal.
304
最新系统安装手册-Windows教学文案
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如何安装电脑声卡驱动 随着操作系统安装包的不断增多，例如vista，安装包已经达到了几G，系统附带的驱动包也变的更加全面。有时候，系统安装好后，很多硬件不用安装驱动就可以正常使用了。但是并不是所有的硬件都能免安装驱动，比如有时候安装完系统后，声卡没有被成功驱动，播放器放不出声音，下面笔者就来介绍下如何安装声卡。 右键点击―我的电脑‖----―属性‖---―硬件‖----―设备管理器‖，展开―声音、视频和游戏控制器‖，看前面有没有黄色的―？‖，有，说明缺声卡驱动，没有，说明该声卡驱动不能正常使用，右击声卡，选―卸载‖将其删除，重新安装驱动。如果有声卡驱动盘，那就很简单了。将声卡的驱动光盘放入光驱，右击―声音、视频和游戏控制器‖下的？号选项，选―更新驱动程序‖，打开―硬件更新向导‖，选―是，仅这一次‖---―下一步‖---―自动安装软件‖--―下一步‖，系统即自动搜索并安装光盘中的声卡驱动程序，如果该光盘没有适合你用的声卡驱动，再换一张试试，直到完成。( 三联教程) 倘若没有声卡驱动盘，可以从网上下载相应的驱动程序。要下载相应的驱动程序，少不了要先确定声卡的型号。不知道声卡型号，看展开的―声音、视频和游戏控制器‖下的那一串字符和数字就是你的声卡型号，也可―开始‖—―运行‖—输入dxdiag, 打开―DirectX诊断工具‖—声音，从打开的界面中找。另外，如果不能查到，一般情况下，这招都不行的；可以用号称世界上最好的硬件检测工具EVEREST中文版。 下载声卡驱动的网站不少，你也可以在综合大型网站主页，把你的声卡型号输入到―搜索‖文本框中，按―搜索‖按钮，从打开的界面中，选你要下载驱动的网站。下载驱动软件要注意：一是品牌型号要对，二是在什么系统上便用，三是要看该驱动软件公布的时间，最新的未必适合使用，可多下载几个，挑着使。 下载的驱动软件一般有自动安装功能，打开后，点击即自动安装。不能自动安装的，解压后备用，要记下该软件在磁盘中的具体路径，如E：…………。右击―我的电脑‖----―属性‖---―硬件‖----―设备管理器‖，打开―声音、视频和游戏控制器‖，右击―声音、视频和游戏控制器‖ 下的？号声卡选项，选―更新驱动程序‖，打开―硬件更新向导‖，去掉―搜索可移动媒体‖前的勾，勾选―从列表或指定位置安装‖---―下一步‖，勾选―在搜索中包括这个位置‖，在下拉开列表框中填写要使用的声卡驱动文件夹的路径（E：…………---―下一步‖，系统即自动搜索并安装你指定位置中的声卡驱动程序。 安装完声卡驱动后，如果仍然没有声音，将声卡换一个插槽试试。此外还可以进我的电脑的硬件设备管理器–右击声卡—属性--资源—看有没有冲突，有进BIOS通过设置解决。 上述方法，相信对一个对驱动安装不大熟悉的朋友来说，也基本能解决声卡驱动问题了。
系列服务器windows操作系统安装步骤
IBM X系列服务器Windows操作系统安装步骤
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WINDOWS XP系统安装步骤
WINDOWS XP系统安装步骤 一、设置光驱启动 1、找一张带启动功能的WINDOWS XP安装光盘放入光驱中。 2、重新启动计算机，并在开机自检时按F2键进入CMOS设置。 3、选择Advanced CMOS Setup（高级COMS设置）项，按Enter键进入。 4、移动↑、↓移动到Boot Device Priority（启动设备顺序设置），并按Enter键进入。 5、移动↑、↓移动到1ST（即第1启动设备，2nd、3rd、4th表示第2、第3、第4启动设备）并按Enter键进入。 6、移动↑、↓移动到CD/DVD，并Enter键设置成功。 说明：此项进入后主要有4个选择项，分别表示： Disable：禁止，IDE－0：从硬盘启动，Floopy:1.44MB 3 1/2：从3.25英寸1.44MB软盘启动，CD/DVD：从普通光驱或者DVD光驱启动。 7、按F10键并按“Y”字母保存设置，保存后电脑会重新启动。 提示：不同的主板有不同的设置，但大部分是如此。对于一些与此设置不同的主板，请参考主板说明书。 二、安装XP的步骤 现在，以安装Windows XP原版操作系统为例说明安装步骤。 电脑重新启动自检完成后，会在屏幕的最底下或最上面出现：BOOT FROM CD字样，表示电脑将从光驱启动。后面则会出现“Press qny key to boot from CD”（意思是按任意键将从光驱启动）的提示，时间点从1－5点依次增加，
表示等待5秒钟，如果在这5秒钟之内按下任意一键，则从光盘启动进入XP的安装，如果超过5秒钟，则从硬盘启动进入原来已安装好的系统。 重要说明： ★安装XP总共有3次的重新启动过程： １、第一次即设置光盘启动； ２、第二次是安装程序从光盘上复制了系统安装文件； ３、第三次则是所有必须的系统文件和应用程序已复制到电脑上，安装基本完成，保存好设置后的重新启动。 ★如果在第一次重新启动后将光盘启动设置回硬盘启动或其它设备启动的话，就不再出现BOOT FROM CD字样，如果没有，则还会出现，请在最后2次的重新启动时不要在5秒内按任意键，否则又进行重复重制文件的过程。切记！ XP系统盘光启之后便是蓝色背景的安装界面，这时系统会自动分析计算机信息，不需要任何操作，直到显示器屏幕变黑一下，随后出现蓝色背景的中文界面。 这时首先出现的是XP系统的协议，按F8键（代表同意此协议），之后可以见到硬盘所有分区的信息列表，并且有中文的操作说明。选择C盘，按D键删除分区（之前记得先将C盘的有用文件做好备份），C盘的位置变成“未分区”，再在原C盘位置（即“未分区”位置）按C键创建分区（说明：如果以前的系统被病毒破坏了，并无法修复，建议把所有的硬盘全部删除，再重新分区，然后在安装完成后再格式化，这样可以彻底清除残留在硬盘中的病毒）。之后原C盘位置变成了“新的未使用”字样，按回车键继续。 接下来有可能出现格式化分区选项页面，推荐选择“用FAT32格式化分区
2017天然药物化学期末考试答案
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答案C 解析3. (2分)通常以树脂.苦味质.植物醇等为存在形式的萜类化合物为（） ? A. 单萜 ? B. 二萜 ? C. 倍半萜 ? D. 二倍半萜 ? E. 三萜 得分：2 知识点：天然药物化学考试题 答案B 解析4. (2分) 对下述结构的构型叙述正确的是（） ? A. α-D型， ? B. β-D型， ? C. α-L型， ? D. β-L型 得分：0
知识点：天然药物化学作业题 答案C 解析5. (2分)原理为氢键吸附的色谱是（） ? A. 离子交换色谱 ? B. 凝胶滤过色谱 ? C. 聚酰胺色谱 ? D. 硅胶色谱 ? E. 氧化铝色谱 得分：2 知识点：天然药物化学作业题 答案C 解析6. (2分)在蒽醌衍生物UV光谱中，当262～295nm吸收峰的logε大于4.1时，示成分可能为（） ? A. 大黄酚 ? B. 大黄素 ? C. 番泻苷 ? D. 大黄素甲醚 ? E. 芦荟苷 得分：2 知识点：天然药物化学考试题 答案B 解析7.
(2分)在天然界存在的苷多数为（） ? A. 去氧糖苷 ? B. 碳苷 ? C. β-D-或α-L-苷 ? D. α-D-或β-L-苷 ? E. 硫苷 得分：2 知识点：天然药物化学考试题 答案C 解析8. (2分)在水液中不能被乙醇沉淀的是（） ? A. 蛋白质 ? B. 多肽 ? C. 多糖 ? D. 酶 ? E. 鞣质 得分：2 知识点：天然药物化学作业题 答案E 解析9. (2分)20（S）原人参二醇和20（S）原人参三醇的结构区别是( ) ? A. 3—OH
驱动程序详解及安装方法
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硬件如果缺少了驱动程序的驱动，那么本来性能非常强大的硬件就无法根据软件发出的指令进行工作，硬件就是空有一身本领都无从发挥，毫无用武之地。这时候，电脑就正如古人所说的万事俱备，只欠东风，这东风的角色就落在了驱动程序身上。如此看来，驱动程序在电脑使用上还真起着举足轻重的作用。 从理论上讲，所有的硬件设备都需要安装相应的驱动程序才能正常工作。但像CPU、内存、主板、软驱、键盘、显示器等设备却并不需要安装驱动程序也可以正常工作，而显卡、声卡、网卡等却一定要安装驱动程序，否则便无法正常工作。这是为什么呢？ 这主要是由于这些硬件对于一台个人电脑来说是必需的，所以早期的设计人员将这些硬件列为BIOS能直接支持的硬件。换句话说，上述硬件安装后就可以被BIOS和操作系统直接支持，不再需要安装驱动程序。从这个角度来说，BIOS也是一种驱动程序。但是对于其他的硬件，例如：网卡，声卡，显卡等等却必须要安装驱动程序，不然这些硬件就无法正常工作。 三、驱动程序的界定 驱动程序可以界定为官方正式版、微软WHQL认证版、第三方驱动、发烧友修改版、Beta测试版。初学者尽量安装官方正式版，当然如果你脱离了菜鸟就可以尝试下各种版本的驱动。 动手安装驱动程序之前，必须先搞清楚，哪些硬件是需要安装驱动程序的，哪些是不需要的。根据前面的介绍，CPU、内存、软驱、键盘、显示器等一般都
Windows7安装方法有多少种
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二、模拟光驱/虚拟光驱安装Windows7法： (特定情况下可能安装不能成功) 简述：模拟光驱(或称为虚拟光驱)安装法安装最简单，安装速度快，但限制较多，推荐用于多系统的安装。 方法： 在现有系统下用模拟光驱程序加载系统ISO文件，运行模拟光驱的安装程序，进入安装界面，升级安装时C盘要留有足够的空间。多系统安装最好把新系统安装到新的空白分区。 缺点： 1、由于安装时无法对现有系统盘进行格式化，所以无法实现单系统干净安装。因旧系统文件占用空间，也比较浪费磁盘空间。要有旧的操用系统。 2、因无法格式化旧系统分区，残留的病毒文件可能危害新系统的安全性。 3、旧32位系统无法安装64位系统，旧64位系统无法安装32位系统。 三、Windows7硬盘安装法： (特定情况下可能安装不能成功) 硬盘安装法可分两种： 1、最简单的硬盘安装法：把系统ISO文件解压到其他分区，运行解压目录下的SETUP.EXE文件，按相应步骤进行，不再详述。 此方法限制与缺点同模拟光驱安装法。同样不能格式化旧系统及32/64位不同系统不能混装。推荐用于多系统的安装。
如何在windows7下安装hp1020打印机驱动程序
在 Windows 7 下安装 HP1020 打印机驱动程序方法 注意事项: 电脑上曾经安装过HPLaserJet 激光打印机的驱动程序，重新安装驱动程序之前，需要先删除以前安装的驱动程序，否则可能会出现无法找到设备或者安装不上驱动程序的现象。 一、Windows 7 下手动删除驱动程序的方法。 安装网站下载的即插即用驱动程序前，建议先手动删除打印机驱动程序，然后再安装驱动程序。 适用机型 HP LaserJet 1018、HP LaserJet 1020、HP LaserJet 1022、HP LaserJet P1505、HP LaserJet P1007、HP LaserJet P1008。 操作方法： 依次点击“开始（）”→“控制面板”，在“控制面板”窗口中，点击“设备和打印机”选项。 注:本文以HP LaserJet 1020 激光打印机的操作方法为例，其他型号打印机的操作方法也可以以此作为参考。
在“设备和打印机”窗口中，右键点击“HP LaserJet 1020”图标，选择“删除设备”菜单项。如图 1 删除设备所示： 图1: 删除设备 在“删除设备”窗口中，点击“是”按钮。如图 2 确认删除设备所示： 图2: 确认删除设备
必须断开USB 连接线，重新启动电脑。 重新启动电脑后不要进行任何打印操作。 在“设备和打印机”窗口中，点击“Microsoft XPS DocumentWriter”打印机图标，选择“打印服务器属性”菜单。如图 3 打印服务器属性所示： 图3: 打印服务器属性 在“打印服务器属性”窗口中，点击“驱动程序”选项卡，选择“HP LaserJet 1020”打印机型号，然后点击“删除”按钮。如图 4 属性所示：
抗疟药
原发性红细胞外期： 在蚊子叮咬人体时， 疟原虫孢子进入人体并侵入肝 细胞进行发育繁殖，然后 从肝细胞释放，进入红细胞， 此时无症状，为疟疾的潜伏期。疟原虫感染红细胞时期称 红细胞内期，此时疟原虫产生的代谢产物和红细胞碎片刺激 机体，引起寒战、高热、 出汗等疟疾的临床症状。 继发性红细胞外期： 肝细胞中部分处于休眠状态 疟原虫是疟疾复发的根源。 抗疟药分为3类： （1）控制疟疾症状： 氯喹、奎宁、甲氟喹、 青蒿素、咯萘啶、本芴醇 （2）控制疟疾复发和传播：伯氨喹 （3）疟疾预防： 乙胺嘧啶、磺胺类。 一、控制疟疾症状 主要杀灭红细胞内期疟原虫 氯喹 药理作用： 杀灭红细胞内期的间日疟、 三日疟以及敏感的 恶性疟原虫，迅速控制 疟原虫症状的发作， 对恶性疟有根治作用， 是控制疟疾症状的 首选药物。 特点：起效快、疗效高、 作用持久。 对红细胞外期无效， 不能用作病因性预防和 良性疟的根治。
作用机制： 干扰疟原虫体内代谢产物 的处理，导致虫体溶解； 使疟原虫分解和利用 血红蛋白的能力降低， 引起氨基酸缺乏而 抑制疟原虫的生长繁殖。 氯喹临床应用 （1）控制疟疾的急性发作和根治恶性疟，是治疗 疟疾的首选药物； （2）治疗肠外阿米巴病 可用于甲硝唑治疗无效 或禁忌的阿米巴肝炎 或肝脓肿。 （3）免疫抑制 治疗类风湿性关节炎、 系统性红斑狼疮等。 氯喹不良反应 头晕、头痛、胃肠不适、 皮疹，眼耳毒性、 心血管反应、 白细胞减少、 肝脏、肾脏损害。 心肌损害， 有致畸作用，孕妇禁用。 青蒿素及其衍生物 药理作用 产生自由基，破坏疟原虫 的生物膜、蛋白质等， 使之死亡。 对红细胞内期原虫有效， 对间日疟和恶性疟， 包括耐氯喹虫株有强大而快速 的杀灭作用， 但对红外期疟原虫无效。 主要用于控制症状。 青蒿素临床应用 控制间日疟和恶性疟的症状 治疗耐氯喹虫株，
如何手动安装驱动
如何手动安装驱动？ 作者：Alright 编辑：Alright2010-01-11 10:27:59 13827 人阅读 把所有要安装的驱动程序都准备好后，我们就可以开始安装驱动程序了。驱动程序的安装方法也有很多种，下面就从易到难慢慢来看看。 1.安装傻瓜化——双击安装 现在硬件厂商已经越来越注重其产品的人性化，其中就包括将驱动程序的安装尽量简单化，所以很多驱动程序里都带有一个“Setup.exe”可执行文件，只要双击它，然后一路“Next（下一步）”就可以完成驱动程序的安装。有些硬件厂商提供的驱动程序光盘中加入了Autorun 自启动文件，只要将光盘放入到电脑的光驱中，光盘便会自动启动。 然后在启动界面中单击相应的驱动程序名称就可以自动开始安装过程，这种十分人性化的设计使安装驱动程序非常的方便。 2.从设备管理器里自己指定安装 如果驱动程序文件里没有Autorun自启动也没有有“Setup.exe”安装可执行文件怎么办？这时
我们就要自己指定驱动程序文件，手动安装了。 我们可以从设备管理器中来自己指定驱动程序的位置，然后进行安装。当然这个方法要事先准备好所要安装的驱动程序，该方法还适用于更新新版本的驱动程序。 首先从控制面板进入“系统属性”，然后依次点击“硬件”——“设备管理器”。 如图，网卡是没有安装驱动程序的设备，其前面会有感叹号“！”标示。 右键点击该设备，然后选择“更新驱动程序”。
接着就会弹出一个“硬件更新向导”，我们既然知道了它是属于什么型号的设备，而且还有它的驱动程序，选择“从列表或指定位置安装”。
如果驱动程序在光盘或软盘里，在接着在弹出的窗口里把“搜索可移动媒体”勾上就行，如果在硬盘里，则把“在搜索中包括这个位置”前面的复选框勾上，然后点“浏览”。接着找到咱们准备好的驱动程序文件夹，要注意的是很多硬件厂商会把其生产的很多类型的硬件设备驱动都压制在一张盘中，而且还会有不同的操作系统版本，如For Win2K（Win2000）和For WinXP的，要注意选择正确的设备和操作系统版本。点“确定”之后，点击“下一步”就行了。
中药药理试题
1、较长时间用药可引起血小板减少症的药物是 A、穿琥宁注射液? B、生天南星? C、蟾酥? D、关木通? E、鸦胆子? 2、“四气”不包括 A、寒? B、凉? C、温? D、热? E、平? 3、以下药物具有致癌作用的是 A、甘草? B、黄芩? C、山豆根? D、雷公藤? E、川楝子? 4、以下哪项是酸味药的主要药理作用 A、抗肿瘤? B、解热? C、发汗? D、利胆? E、保护创面? 5、以下不属于妊娠禁忌药物的是 A、附子? B、肉桂? C、黄芩? D、桃仁? E、大黄? 6、以下哪项是相畏配伍的目的 A、协同作用? B、减少个体差异? C、更易吸收? D、加速分布? E、减少毒性? 7、苦味药抗菌、抗炎、解热的主要成分是 A、生物碱? B、黄酮? C、苷类? D、挥发油? E、有机酸? 二、B 1、A.单行、相使B.单行、相反C.相恶、相反D.相须、相使E.相畏、相杀 <1>?、起增强疗效作用的配伍是 <2>?、起降低毒性或消除毒性作用的配伍是 1、解表药的主要药理作用，下列表述有误的是 A、固表止汗作用? B、解热作用? C、抗病原微生物作用? D、镇痛、镇静作用? E、抗炎和调节免疫作用? 2、下列药物解热作用最显着的是 A、柴胡? B、紫苏? C、防风? D、葛根? E、桂枝? 3、以下药物发汗作用机制是通过抑制汗腺导管对钠离子重吸收而产生的是 A、荆芥? B、防风? C、麻黄? D、桂枝? E、生姜? 4、以下哪项是麻黄平喘的有效成分 A、桂皮油? B、小檗碱? C、绿原酸? D、麻黄碱? E、皂苷类? 5、以下哪项是桂枝的现代应用 A、支气管哮喘? B、病毒性肝炎? C、偏头痛? D、突发性耳聋? E、低血压症? 6、以下哪种药物治疗突发性耳聋 A、柴胡? B、葛根? C、细辛? D、麻黄? E、桂枝? 7、细辛的药理作用不包括的是 A、保肝? B、平喘? C、镇静? D、解热? E、镇痛? 8、以下具有保肝利胆作用的药物是 A、柴胡? B、细辛? C、葛根? D、麻黄? E、桂枝? 9、以下哪项是柴胡影响脂质代谢的主要成分 A、柴胡挥发油? B、柴胡皂苷? C、柴胡多糖? D、苷类? E、黄酮类成分? 10、以下哪项不属于麻黄的主治范围 A、支气管哮喘? B、低血压? C、感冒? D、白细胞减少症? E、鼻塞? 11、柴胡的现代应用不包括
电脑驱动程序安装顺序
台式机和笔记本的驱动程序安装顺序 下表概述了在戴尔台式机和笔记本上安装驱动程序的正确顺序。重新安装Microsoft? Windows? 后，请按照列出的顺序来重新安装驱动程序。建议您打印此列表以供安装驱动程序时参考。 注：如果未按顺序安装驱动程序，某些设备可能无法正常工作。 1. 台式机系统软件 (DSS) 或笔记本系统软件 (NSS)—可为操作系统提供关键更新和补丁程序的重要实用程序。如果要重新安装 Windows 驱动程序或更新全部驱动程序，则一定要先安装该软件。 DSS和NSS位于 Drivers and Downloads (驱动程序和下载)页面上的System Utilities Category (系统公用程序类别)的栏目内。 2. 芯片组—帮助 Windows 控制系统主板组件和控制器。位于 Drivers and Downloads (驱动程序和下载)页面上的 ChipsetCategory(芯片组及智能卡类别)的栏目内。 3. 显卡—增强视频性能。位于 Drivers and Downloads (驱动程序和下载) 页面上的Video Category (显卡类别)的栏目内。 4. 集成网卡(NIC)—启用和增强用于互联网或有线网络访问的网络控制器。此类驱动程序位于Drivers and Downloads (驱动程序和下载)页面上的Network Category (网卡无线及蓝牙类别)的栏目内。 5. 仅限笔记电脑：Dell Quickset 或 Dell Control Point Manager (DCP)—控制笔记本电脑上的电源管理、环境光线传感器、无线配置文件和安全功能。此类驱动程序位于 Drivers and Downloads (驱动程序和下载)页面上的Applications (应用程序)的栏目内。 6. 声卡—启用和增强音频控制器。此类驱动程序位于 Drivers and Downloads (驱动程序和下载)页面上的Audio Category (声卡类别)的栏目内。 7. 调制解调器—具有拨号上网功能。此类驱动程序位于 Drivers and Downloads (驱动程序和下载)页面上的 Communication Category (Modem和通讯类别)的栏目内。 8. 无线网卡—启用和增强无线网络控制器。此类驱动程序位于 Drivers and Downloads (驱动程序和下载)页面上的Network Category (网卡无线及蓝牙)的栏目内。
北京中医药大学远程教育《中药化学B》作业5答案
A型题： 1. 可用于区别甾体皂苷和三萜皂苷的呈色反应是 A.氯仿一浓硫酸反应 B.香草醛一浓硫酸反应 C.Liebermann一Burchard反应 D.五氯化锑反应 E.浓硫酸反应 2. 环烯醚萜苷的性质有 A.易被酸水解 B.苷键稳定不易水解 C.苷元不易氧化聚合 D.其苷元与氨基酸 不产生反应 E.与shear试剂不产生反应 3. 甾体皂苷C25构型为D型，则 A.25S B.25L C.Neo D.Iso E.25βF 4. 提取环烯醚萜苷时加入醋酸铅，除（）外均可除去 A.酸性杂质 B.鞣质 C.3’、4’-二OH黄酮类 D.树脂醇 E.有机酸 5. α-细辛醚和β-细辛醚的分离最好采用 A.SiO2层析 B.Al2O3层析 C.AgNO3层析 D.化学分离法 E.水蒸气蒸馏法 6. 皂苷类化合物利用酶控制水解可得到 A.缩水苷元 B.真正苷元 C.异构化苷元 D.丙酮化苷元 E.消旋化苷元 7. 齐墩果酸结构类型是 A.螺旋甾烷醇型 B.β-香树脂醇型 C.α-香树脂醇型 D.羽扇豆醇型 E.达玛烷型 8. 二萜分子中异戊二烯数目是 A.2个 B.3个 C.4个 D.5个 E.6个 9. A、B型人参皂苷用一般酸(4mol／L HCl)水解法水解，得到的苷元是 A.前人参皂苷元 B.20(S)一原人参皂苷元 C.20(R)--原人参皂苷元 D.20（S）
一和20（R）一混合的原人参皂苷元 E.人参二醇和人参三醇 10. 能与甾体皂苷生成分子复合物沉淀的甾醇类化合物，其结构必须具有 A.3α-0H B.3α-O-糖基 C.3β-OH D.3β-O-糖基 E.3α-O-羧基 11. 用溶剂法提得的挥发油，含的杂质主要是 A.油脂 B.粘液质 C.水 D.树胶 E.分解产物 12. 龙胆苦苷的母核是 A.单萜 B.二萜 C.三萜 D.环烯醚萜 E.倍半萜 13. 龙脑是 A.单萜 B.倍半萜 C.二萜 D.三萜 E.环烯醚萜 14. C12为羰基的甾体皂苷元与浓硫酸反应后，其紫外吸收光谱 A.270nm有吸收 B.350nm有吸收 C.270nm及350nm均有吸收 D.270nm及350nm均无吸收 E.无吸收 15. 薄荷油中的主要成分是 A.薄荷醇 B.薄荷酮 C.薄荷醛 D.异薄荷醇 E.新薄荷醇 16. 紫杉醇是 A.单萜 B.二萜 C.三萜 D.环烯醚萜 E.倍半萜 17. 水解人参皂苷欲得到真正的皂苷元应用 A.霍夫曼降解 B.埃姆得降解 C.史密斯降解 D.酸水解 E.碱水解 18. 甾体皂苷的红外光谱中，在980（A）,920（B）,900（C）, 900（D）cm-1附近有4个特征吸收峰，螺旋甾烷型的特征是错误：正确答案为：B A.A吸收峰比B吸收峰强 B.B吸收峰比C吸收峰强 C.C吸收峰比D吸收峰强 D.D吸收峰比A吸收峰强 E.C吸收峰比B吸收峰强
驱动程序安装方法
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正版Windows7系统安装方法
随着Windows7的普及，想使用WIN7操作系统的人确实不在少数，但多部分人都不懂得如何安装，看别人使用，而自己却不能使用！去电脑城买个盗版的系统盘吧，总是被强制安装很多软件，有时还有毒，很不安全！那就只能用XP，总感觉心理挺难受的吧。 好了废话不多说了，现在我就教大家如何使用虚拟光驱安装官方正版的WIN7系统吧。（注意：这里教安装的是单系统的WIN7，想装双系统只须将WIN7系统安装在原系统以外的分区即可，这里不进行详细讲述。） 虽然微软并没有免费发布出WIN7旗舰版提供下载，但是只要你想要。一切还是有的，嘿嘿 Windows 7 x86版下载地址：https://www.wendangku.net/doc/986481038.html,/ghostxp/966.htm Windows 7 x64版下载地址：https://www.wendangku.net/doc/986481038.html,/ghostxp/965.htm x64 是指CPU是64位版本的。x86 是指CPU是32位版本的。如果你的CPU是64位的。可以安装64位的，也可以安装32位的，反过来只能安装32位的。又普及了一个知识，这时 候可以有掌声了 下面我们正式开始： 1.我们将下载好的WIN7镜像用虚拟光驱载入，如果电脑开启了自动播放功能就会弹出如下图所示对话框
如果没有这个对话框的用户不要着急，我们可以进到虚拟光驱将这个程序打开就可以实现相同的效果。
在上图中，我们看到的这些文件就是用虚拟光驱载入的WIN7镜像文件所产生的，此时我们只需要运行“setup.exe”程序就会出现如下图所示的对话框
我们点击“现在安装（I）”按扭开始安装。等会就会出现如下图窗口
中国人发现抗疟新药青蒿素的经过
中国人发现抗疟新药青蒿素的经过 知情者* 始于1964年的越南战争，由于疟原虫对一些常用抗疟药已产生抗药性，战争双方死于恶性疟的士兵，在数量上大大超过战争中的伤亡人数。当时的越南领导人为此向中国方面求援。中方于1967年5月23日，授权中国人民解放军总后勤部、中国国家科学技术委员会、中华人民共和国卫生部、中华人民共和国化工部、国防科委、中国科学院和医药工业总公司共同组成“五二三领导小组”，负责组织其下属机构进行研究，立项名称为“五二三项目”，周恩来总理亲自过问。尽管当时正值文化大革命，正常工作受到严重干扰，但是“五二三领导小组”仍然动员了全国六十余个单位约五百名各种专业的科研人员，组成各个专业协作组，充分利用国内的仪器设备，形成一个多学科紧密联系、团结互助和工作有序的科研团队。 “五二三项目” 的主要任务是“寻找用于预防和治疗热带地区抗药性恶性疟的抗疟新药”。“全国五二三办公室”建议从两方面筛选新药，一是化学合成新的抗疟药，一是从调查传统的中药和民间草药常用的抗疟药着手，并分别成立了两个协作组，“中医中药专业组”就是其中之一，试图通过传统中药或民间草药寻找符合要求的抗疟新药。这就是中国人从中药青蒿中发现抗疟新药青蒿素的历史背景及其科研团队的组织情况[张剑方，《迟到的报告—五二三项目与青蒿素研发纪实》，羊城晚报出版（2006）（以下简称“张剑方《迟到的报告》”），5－11页]。 发现青蒿素不同于发现一般的天然化合物，因为青蒿素的价值是在它的化学结构的新颖性和由此而具有独特的抗疟特性和无抗药性的优点。上世纪七十年代初期，中国和当时的南斯拉夫科学家不约而同地在进行黄花蒿（Artemisia annua L.）天然化合物的研究，都得到了相同分子式C 15H 22 O 5 和分子量的化合物，但是南 斯拉夫科学家定错了其化学结构[Jeremic, D., Jokic, A. and Stefanovic, M., New Type of Sesquiterpenen Lactone isolated from Artemisia annua L.– Ozonide of Dihydroarteannuin, presented at the 8th Int. Symp on Chemistry of Natural Products, New Delhi (1972) 222 (Posted by Gong Wai Lihm 江威廉on https://www.wendangku.net/doc/986481038.html,/ at the time of May 3, 2008)]。实际上，黄花蒿就是中药抗疟药青蒿的原植物。当时正值文化革命，中国科学家完全不知道南斯拉夫的工作。1986年其中一位南斯拉夫科学家访问中国时说，“即使我们给出正确的
联想电脑驱动程序安装指引
联想电脑驱动程序安装指引 重要提示： 1．下面指引中对光盘盘符统一以“X”为代表。 2．驱动安装前请保证操作系统正确安装完毕，并保证光驱中正确放置了随机配备的联想电脑驱动光盘。 3．本指引仅提供整机主要驱动的安装路径及简单的操作说明。 4．本指引中提到的Microsoft、MS-DOS、Windows、Windows NT、Windows XP、Windows Vista、Windows 7是Microsoft公司的注册商标。 Intel、Intel Pentium、Intel Penryn是Intel公司的注册商标。 5．单击文中超链接，对于安装过程中的选择提示，按照系统提示的默认项操作，完成驱动安装 6．如文中超链接由于某种原因单击失效，请按照链接明文提示在光盘指定位置安装。 7．安装相关硬件驱动前请确认硬件处于开启状态。 一、芯片组驱动安装（32位和64位）: 驱动安装路径：“X:\Win7\1.Chipset\Setup.exe” 二、AHCI驱动安装（32位和64位）: 驱动安装路径：“X:\Win7\2.AHCI\setup.exe” 三、 MEI 驱动安装（32位和64位）: 驱动安装路径:“ X:\Win7\3.MEI\Setup.exe” 四、显示适配器（VGA）的驱动安装: 集成显卡驱动： Intel集成显卡安装路径x32：“X:\Win7\4.VGA\Intel\x32\Setup.exe” Intel集成显卡安装路径x64：“X:\Win7\4.VGA\Intel\x64\Setup.exe” 独立显卡驱动： Nvdia独立显卡驱动安装路径x32：“X:\Win7\4.VGA\nVidia\x32\setup.exe” Nvdia独立显卡驱动安装路径x64：“X:\Win7\4.VGA\nVidia\x64\setup.exe” Intel智能电源共享（I5&I7系列CPU需要安装此驱动）（x32&x64）： “X:\Win7\4.VGA\nVidia\DIS\setup.exe” 五、声卡（Audio）驱动安装(32位和64位): 驱动安装路径：“X:\Win7\5.Audio\Setup.exe” 六、网卡（Lan）驱动安装(32位和64位): 网卡驱动安装路径: “X:\Win7\https://www.wendangku.net/doc/986481038.html,N\setup.exe” 七、无线网卡（Wireless Lan）驱动安装: Intel网卡驱动安装路径：
Windows7系统下载安装(7600旗舰版)+激活方法图文教程
Windows7系统下载安装(7600旗舰版)+激活方法图文教程 旗舰, 教程 随着Windows7（以下简称WIN7）的出现，着实让使用Vista的用户可以喘口气了，传说中WIN7有着Vista的华丽效果，XP的速度，在配置要求方面也是普通机器就可以玩转的，而且在兼容方面已经可以跟XP比拟了，当然，最大的消息就是预装了Vista正版操作系统的用户可以免费升级至WIN7操作系统。虽然微软并没有正式发布出WIN7正式版提供下载，但是网上出现的众多所谓的7600RTM旗舰版被称为微软的泄密版，下载地址：https://www.wendangku.net/doc/986481038.html,/windows7xt/504.htm，经过1个星期的测试，确实可以实现正版激活，虽然测试阶段并不想微软公布那样好，但是已经接近90%了，相比Vista而言已经好了不知道多少倍了，而且对比XP那简单的画面以及安全方面也提高了不少，相信大家已经 很期待尝试WIN7了吧！ 经过了长时间的观察，想使用WIN7操作系统的人确实不在少数，但多部分人都不懂得如何安装，看别人使用，而自己却不能使用，总感觉心理挺难受的吧。好了废话不多说了，现在我就教大家如何使用虚拟光驱安装WIN7系统吧。（注意：本教程只负责教授安装单系统的WIN7，想装双系统只须将WIN7系统安装在原系统以外的分区即可，这里不进行详细讲 述。） 虚拟光驱Daemon Tools 4.30下载地址:https://www.wendangku.net/doc/986481038.html,/ghostxp/834.htm 下面我们正式开始： 1.我们将下载好的WIN7镜像用虚拟光驱载入，如果电脑开启了自动播放功能就会弹出如下 图所示对话框