Regulatory Support

• USP <1111> Microbiological examination of nonsterile products: acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use. USP32-NF27, 2009
• USP <51> Antimicrobial effectiveness testing
• USP <61> Microbiological examination of nonsterile products: microbial enumeration tests
• USP <62> Microbiological examination of nonsterile products: tests for specified microorganisms
• USP <71> Sterility tests
• USP <1223> General chapter, “Validation of Alternative Microbiological Methods, USP 32-NF 27, 2009
• EP <5.1.6> General texts on Sterility, “Alternative methods for control of microbiological quality”, 2008
• FDA. Guidance for industry: PAT - A framework for innovative pharmaceutical development, manufacturing, and quality assurance, 2006
• FDA. Guidance for industry: Sterile drug products produced by aseptic processing. Current GMP, Sept. 2004.
• FDA. Final report on pharmaceutical cGMPs for the 21st century - A risk-based approach, 2003.
• PDA TR#33 “The Evaluation, Validation and Implementation of New Microbiological Testing Methods” TR # 33 (3), 2000 – Currently under revision
• EP < 5.1.3> Efficacy of antimicrobial preservation
• NF T75-611 Evaluation de la protection antimicrobienne d'un produit cosmetique
• BAM (Bacteriological Analytical Manual) - FDA's BAM presents the agency's preferred lab procedures for microbiological analyses of foods and cosmetics
• EP <2.6.14> methodology for bacterial endotoxin testing
• USP <85> Bacterial endotoxins test
• Japanese Pharmacopoeia (General Tests, No. 4.01)
• USP <151> Pyrogens test
• AAMI ST72:2002: Bacterial endotoxins - Test methodologies, routine monitoring, and alternatives to batch testing