Changes in USP Microbial Limit Test
USP Microbial Limit Test was revised on May 1, 2009 into two separate sections: USP Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests and Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms.
Testing of Glycerin for Diethylene Glycol
The Office of Compliance in the Center for Drug Evaluation and Research (CDER) provides Guidance for Industry concerning the “Testing of Glycerin for Diethylene Glycol.”
Now available a closed system membrane filtration test of sterility utilizing the Millipore Steritest System for maximum assurance against a false negative response.
CGMP Manufacturing Practice Regulations for Finished Pharmaceuticals
Final Rule: CGMP Manufacturing Practice Regulations for Finished Pharmaceuticals. Released September 8, 2008. Effective December 8, 2008. Amendments have been made to the CGMP for finished pharmaceuticals. Included in the three areas targeted for change is Aseptic Processing, specifically §211.113(b), §211.67(a), §211.84(d)(6), and §211.110(a).
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Toxicology / Biocompatibility
Sample Requirements for Biocompatibility Testing [ PDF | DOC ]
Antimicrobial Effectiveness Testing [ PDF | DOC ]
Environmental Monitoring [ PDF | DOC ]
Sterilization Process Validation
ANSI/AAMI/ISO 11137-2 ; Method to Substantiate 25 kGy for Gamma Sterilization [ PDF | DOC ]
Validation of the EtO Sterilization [ PDF | DOC ]