A rational approach for setting and maintaining specifications for biological and biotechnology-derived products Part 2

BioPharm International

Volumn 21, Issue 7, 2008, Pages 32-40

  Schofield, Timothy ^a   Apostol, Izydor ^b   Koeller, Gerhard ^c   Powers, Susan ^d   Stawicki, Mary ^e   Wolfe, Richard A ^d  

^a MERCK RESEARCH LABORATORIES   (United States)

^b AMGEN INC   (United States)

^c BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^d PFIZER INC   (United States)

^e GLAXOSMITHKLINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOTECHNOLOGY; DATA ANALYSIS; HUMAN; MARKETING; MATERIALS TESTING; PRODUCT DEVELOPMENT; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; SHELF LIFE; STATISTICAL ANALYSIS;

EID: 48249088801     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (4)

1. International Conference on Harmonization (ICH). Q1E, Evaluation of stability data. Geneva, Switzerland; 2003.
2. ICH. Q6A, Specifications for new drug substances and products. Geneva, Switzerland; 1999.
3. US Food and Drug Administration. Guidance for Industry: Investigating out of specification (OOS) test results for pharmaceutical production. Rockville, MD: 2006.
4. Foust L, Diener M, Gorko MA, Hofer J, Larner G, LeBlond D, Lewis J, Sandell D, Schofield T, Vukovinsky K, Warner E. Overcoming disincentives to process understanding in the pharmaceutical CMC environment. Pharm Technol. 2007 Sept;31(9):108-115.