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)
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
As a “Frequently Asked Questionâ€, 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
In June 2015 ICH issued a Q & AÂ 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...]
