There is no doubt that these occurrences of microbial contamination are a failure of one or more elements of contamination control. Perhaps it was an inadvertent ...
Pharmaceutical manufacturers engaged in biotechnology, pharmaceutical, medical device, home and personal care, and other related manufacturing industries need to be meticulous in creating and ...
A two-year series of 539 evaluations of the aseptic technique of pharmacists and technicians conducted with sterile growth medium and designed to simulate the compounding of USP medium-risk-level ...
A comprehensive contamination control strategy must include a dedicated section addressing personnel-related microbiological and particulate contamination risks introduced into an aseptic process, as ...
One of the main goals of pharmaceutical regulatory rules is to keep environmental contamination at a minimum. According to the EU GMP Annex 1 regulatory standard for sterile drug products, a ...
The US Food and Drug Administration (FDA) recently issued two warning letters to a sterile drug manufacturer and an over-the-counter (OTC) drug maker in the US for multiple violations of good ...
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