Rapid microbiology methods in the pharmaceuticals industry

American Pharmaceutical Review

Volumn 7, Issue 2, 2004, Pages 28-31

  Riley, Bryan S ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

ACCURACY; ARTICLE; DRUG CONTAMINATION; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG QUALITY; DRUG STERILITY; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; INTERMETHOD COMPARISON; MICROBIAL IDENTIFICATION; MICROBIOLOGICAL EXAMINATION; NONHUMAN; QUALITATIVE ANALYSIS; QUANTITATIVE ANALYSIS; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; VALIDATION PROCESS;

EID: 2442431704     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (7)

1. Chapter <51>, Antimicrobial Effectiveness Testing, USP 26, USPC, Inc., Rockville, MD, p. 2002, (2003).
2. Chapter <61>, Microbial Limits Tests, USP 26, USPC, Inc., Rockville, MD, p. 2006 (2003).
3. Chapter <71>, Sterility Tests, USP 26, USPC, Inc., Rockville, MD, p. 2011 (2003)
4. Technical Report No. 33, Evaluation, Validation and Implementation of New Microbiological Testing Methods, PDA Journal of Pharmaceutical Science and Teehnology, Supplement TR33, vol. 54, no 3 (2000).
5. Draft Guidance for Industry, PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, FDA (2003).
6. Draft Guidance for Industry, Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP, FDA (2003).
7. Draft Guidance for Industry, Comparability Protocols - Chemistry, Manufacturing, and Controls Information, FDA (2003).