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PDA TR 67-2014

Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices, and Cosmetics

The scope of this technical report is the exclusion of objectionable microorganisms from nonsterile pharmaceutical drug products, over-the-counter (OTC) drug products; medical devices; cosmetics; and personal care products in the pharmaceutical, medical device, cosmetics and consumer healthcare industries (referred to as “our industry” in the remainder of this report).

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Parenteral Drug Association [pda]

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