Tuesday, 18 November 2014

Exclusion of Objectionable Microorganisms

The PDA has issued a new publication of interest:

PDA Technical Report No. 67 'Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices, and Cosmetics'.

The purpose of the publication is:


“The purpose of this technical report is to provide guidance to the nonsterile producmanufacturing industry on how to manage the microbial risks associated with manufacturing and storage and how to determine what isolates would be deemed an objectionable microorganism in nonsterile products that is in alignment with the microbial limits requirements for releasing these products into the marketplace. Nonsterile products exceeding the microbial count limit and/or containing specified microorganisms for their product type would be expected to be rejected. Specified microorganisms include microorganisms with compendial requirements to be absent in a particular dosage form, and/or required by a national board of health to be excluded from a registered non-sterile product. The contamination of marketed products by potentially objectionable microorganisms continues to be an infrequent but chronic problem. A U.S. survey of reported microbiologically related recalls between 2004 and 2011 found that 72% of recalls of nonsterile products were associated with objectionable microorganisms rather than exceeding microbial enumeration limits (1). Of the 144 recalls for nonsterile products, 5% involved nonsterile pharmaceutical drug products, 42% were for OTC drug products, 31% were for cosmetics, 14% were for medical devices and 8% were for dietary supplements. The average rate of reported recalls is 20 per year.”

For details see: PDA

Posted by Tim Sandle

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