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Assessment of Blend and Content Uniformity. Technical Discussion of Sampling Plans ASTM E2709E2810

RESEARCH ARTICLE

Assessment of Blend and Content Uniformity.Technical Discussion of Sampling Plans and Application

of ASTM E2709/E2810

James Bergum&Thomas Parks&James Prescott&

Ravindra Tejwani&Jon Clark&William Brown&

Fernando Muzzio&Samir Patel&Charles Hoiberg

#Springer Science+Business Media New York2014

ABSTRACT

Introduction The FDA withdrew the draft guidance document for industry“Powder Blends and Finished Dosage Units—Stratified In-Process Dosage Unit Sampling and Assessment.”An FDA’s primary concern was a lack of confidence that the results from USP<905>Uniformity of Dosage Units testing ensure the content uniformity of a batch.ISPE sponsored the Blend Uniformity and Content Uniformity Group(referred to as Group),which was formed in August2013to discuss approaches to assess blend and content uniformity. Modifications to the withdrawn draft stratified sampling guid-ance document are proposed by the Group for the assessment of adequacy of powder mix and content uniformity of the finished product in“Recommendations for the Assessment of Blend and Content Uniformity:Modifications to Withdrawn FDA Draft Stratified Sampling Guidance,”accepted by J Pharm Innov,2014.Specific statistical methodologies to construct acceptance criteria were not recommended in the paper.This paper pro-vides an example and technical discussion of a statistical ap-proach that can be inserted into the framework described in the Group’s paper.There may be other approaches to sampling plans,statistical analysis,and acceptance criteria that are ac-ceptable to demonstrate content uniformity.

Method ASTM E2709,“Standard Practice for Demonstrating Capability to Comply with an Acceptance Procedure”and E2810,“Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units”for demonstrating dosage unit uniformity can be used to evaluate content uniformity.These standards are discussed and applied to the sampling plans given in the Group’s paper.The method can provide with a high level of confidence that samples from a lot will have a high probability of passing the USP UDU

Assessment of Blend and Content Uniformity. Technical Discussion of Sampling Plans ASTM E2709E2810

test. The views presented in this article by the authors do not necessarily reflect

those of their respective companies or organizations.

J.Bergum(*)

BergumSTATS,Howell,NJ,USA

e-mail:james.bergum@http://www.wendangku.net/doc/f59c89cf5122aaea998fcc22bcd126fff7055d6e.html

T.Parks

Eli Lilly and Company,Indianapolis,IN,USA

e-mail:tparks@http://www.wendangku.net/doc/f59c89cf5122aaea998fcc22bcd126fff7055d6e.html

J.Prescott

Jenike and Johanson,Inc.,Tyngsboro,MA,USA

e-mail:jkprescott@http://www.wendangku.net/doc/f59c89cf5122aaea998fcc22bcd126fff7055d6e.html

R.Tejwani

Bristol-Myers Squibb Company Research and Development,New

Brunswick,NJ,USA

e-mail:ravi.tejwani@http://www.wendangku.net/doc/f59c89cf5122aaea998fcc22bcd126fff7055d6e.html

S.Patel

Teva Pharmaceuticals,North Wales,PA,USA

e-mail:Samir.Patel@http://www.wendangku.net/doc/f59c89cf5122aaea998fcc22bcd126fff7055d6e.html

J.Clark

:W.Brown

United States Pharmacopeia-National Formulary,Rockville,MD,

USA

J.Clark

e-mail:JEC@http://www.wendangku.net/doc/f59c89cf5122aaea998fcc22bcd126fff7055d6e.html

W.Brown

e-mail:WEB@http://www.wendangku.net/doc/f59c89cf5122aaea998fcc22bcd126fff7055d6e.html

C.Hoiberg

Pfizer Inc.,Silver Springs,MD,USA

e-mail:charles.p.hoiberg@http://www.wendangku.net/doc/f59c89cf5122aaea998fcc22bcd126fff7055d6e.html

F.Muzzio

Rutgers University,New Brunswick,NJ,USA

e-mail:fjmuzzio@http://www.wendangku.net/doc/f59c89cf5122aaea998fcc22bcd126fff7055d6e.html

J Pharm Innov

DOI10.1007/s12247-014-9208-z