Over the past several years, the FDA has cited a number of Compounding Centers for compromised aseptic processing. Often this has resulted in only a Form FDA 483. In other cases the actions have resulted in both a Form FDA 483 as well as a subsequent Warning Letter. The Johnson Memorial Cancer Center is one of those that has been cited for both through a 483Â and a … [Read more...]
DOCUMENTATION ISSUES IN PRODUCTION AND THE LABORATORY LEAD TO UNIMARK REMEDIES LTD RECEIVING A WARNING LETTER FOR API ADULTERATION
During March 18-21, 2014 the FDA inspected the pharmaceutical manufacturing facility, Unimark Remedies Ltd., located at 337 Kerala Nalsarovar Road, Kerala Village, Bavla, Ahmedabad District, India. The FDA identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs). These deviations caused … [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...]
