In this week’s news, FDA advises drug and device safety inspectors and more…

US FDA tweaks impurities guidelines with focus on degradation products

The US FDA has revised its guidelines on impurities for a third time to provide drug makers with information on degradation products of the API or reaction products of the drug substance with an excipient and/or immediate container closure system.

The document – available here – makes clear that drug firms “should summarize the degradation products observed during manufacture and/or stability studies of a new drug product.”

According to the FDA the summary should be a sound scientific appraisal of potential degradation pathways in the product and those arising from the interaction with excipients and/or the immediate container closure system.

Microbial contamination in non-sterile products

In a separate guideline the US FDA set out how drug firms should prevent microbial contamination during the production of non-sterile products.

The guideline – available here – applies to non-sterile dosage forms, as well as semi-solid, and liquid non-sterile dosage forms like creams, lotions and swabs, as well as oral solutions and suspensions.

The FDA developed the guideline after reviewing recalls involving contamination of non-sterile dosage forms. “Because spontaneous reports of FAERs are voluntary by definition, the Agency anticipates a degree of under reporting. The actual number of incidents associated with microbiological contamination is likely significantly higher than the number of events reported.”

Advice for drug and device inspectors

In another guideline issued this week the FDA has detailed how inspectors tasked with assessing drug and medical device safety should approach their work.

The document – available here – explains how investigators should use trial data to identify an “unanticipated problem involving risk to human subjects or others” or, for devices, “unanticipated adverse device effects.” It also sets out how such events should be reported.

Also in the news

Chemical and Engineering News looked at how the drug manufacturing services sector responded to the coronavirus pandemic.

Endpoints reported that the US FDA’s vaccine arm is in turmoil with Peter Marks taking charge of the unit following the sudden departure of two top executives.

India is aiming to make an mRNA-based COVID-19 vaccine before the end of the year according to the Wall Street Journal.

Propublica covered allegations that a major consulting firm was working for the opioid industry at the same time as it was advising the US FDA.

STAT looked at the WHO’s effort to add more drugs to its essential medicines list to make them more affordable in low and middle income countries.

CDMO trends

Some developments of note in the contracting sector:

Alcami will invest $31 million to expand its sterile development and manufacturing operation in Charleston, SC. See press release.

Thermo Fisher Scientific has taken charge of a manufacturing site in Lengnau, Switzerland as part of its strategic partnership with CSL Limited. The site will become part of Thermo’s biologics manufacturing network and 200 staff will join the firm.

A market report has predicted that 2022 will be a bumper year for the CDMO sector in terms of industry demand. The report also forecast a surge in M&A activity in the year with contractors trying to grow market share by adding capacity.

Recipharm says its inhaler-focused joint venture with Medspray was won its first pharmaceutical industry customer. See press release.

Altasciences has expanded the range of formulation, manufacturing and analytical services at its facility in Philadelphia, PA. See press release.