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Barry A. Friedman, PhD LLC

FDA Regulatory Compliance for the Pharmaceutical, Biotechnology and Medical Device Arenas

Ps. Aeruginosa Exceeds 2.1 X 107/Gm in Product; Where was the Microbiologist?

April 3, 2016 By Barry Friedman Leave a Comment

Questions often arise regarding when is a microorganism “specified” vs. “objectionable”?  USP<62> lists a total of seven individual and groups of microorganisms to include Ps. aeruginosa that are considered “specified”.  However, in a broader category they are also considered as “objectionable”.   A recent Warning Letter discusses the microbiological results from a … [Read more...]

Another Sunscreen Manufacturer (Jaychem Industries, Ltd.) Receives Warning Letter (090415)

September 27, 2015 By Barry Friedman Leave a Comment

Jaychem Industries

The FDA identified significant violations of current good manufacturing practice (CGMP) regulations during an audit (July 7-10, 2014) of Jaychem Industries, Ltd., Auckland New Zealand and their finished pharmaceuticals, Unfortunately, several other firms to include W.S. Badger Co (Click here) (September 23, 2013), a sunscreen manufacturer, had a huge recall for … [Read more...]

Microbial Limits / Specified Microorganisms Rationale

September 13, 2015 By Barry Friedman Leave a Comment

Microbial Limits / Specified Microorganisms Rationale. Find more at barryafriedman.com

As a “Frequently Asked Question”, the USP is often queried about the determination of microbial limits and specified microorganisms. The following, obtained from USP, provides a clarification for this commonly asked question. In determining the appropriate microbial limit, the USP Microbiology Expert Committee considers such matters as the … [Read more...]

Guidance for Industry. ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients – Questions and Answers. June 2015

September 9, 2015 By Barry Friedman Leave a Comment

In June 2015 ICH issued a Q & A Guidance document that complements the Guidance for Industry Active Pharmaceutical Ingredients, ICH Q7. 2000. Since 2000, experience with implementing the guidance has created a need for clarification of various sections. ICH Q7 should be applied in combination with the principles laid down for development and manufacturing in … [Read more...]

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