USA – Manufacturers object to provisions in FDA’s microbiological quality guidance

An industry trade group and pharmaceutical manufacturers are calling for revisions to the US Food and Drug Administration’s (FDA) draft guidance on microbiological quality considerations for non-sterile drugs (NSDs), which they say proposes onerous new microbiological testing requirements.

The 24-page draft guidance was released for comment in September 2021 and is designed to help manufacturers control microbiological contamination of their non-sterile drugs and stems from FDA’s concerns over a high number of adverse events and recalls associated with contaminated products, including Burkholderia cepacia complex (BCC) in non-sterile water-based drug products.

The major sticking point in the guidance for industry is a recommendation for drugmakers to periodically identify microorganisms in their manufacturing facilities, which Pfizer commented would be a “significant new requirement” that is not necessary for NSDs and which would be unsustainable for manufacturers. (RELATED: FDA addresses microbial contamination in non-sterile drugs, Regulatory Focus 29 September 2021)…