Informational

Notices

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." more...

Now available – a closed system membrane filtration test of sterility utilizing the Millipore Steritest System for maximum assurance against a false negative response.

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). more...

Newsletters/Articles

Browse our latest newsletters and articles, listed below. All documents are in PDF format, which will require a PDF reader, such as Adobe Acrobat Reader to view them. They are also available as Word Documents.

Toxicology / Biocompatibility

Sample Requirements for Biocompatibility Testing [ PDF | DOC ]
Evaluation Tests to Consider - ISO 10993-1:2003 [ PDF | DOC ]

Microbiology

Antimicrobial Effectiveness Testing [ PDF | DOC ]

Special Projects

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 ]