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trade group and pharmaceutical manufacturers are calling for revisions to the US Food and Drug Administration’s (FDA) draft guidance on microbiological quality considerations for non-sterile drugs (NSDs), which they say proposes onerous new microbiological testing requirements.
The 24-page draft guidance was released for comment in September 2021 and is designed to help manufacturers control microbiological contamination of their non-sterile drugs and stems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)…
