CMO quality audits: necessary and beneficial to all, says consultant

By Dan Stanton contact

- Last updated on GMT

CMO QA audits: necessary and beneficial to all, says consultant

Related tags: Regulation

A quality assurance audit is as beneficial to the CMO as it is to the sponsor selecting a third-party manufacturer, according to an ex-Merck Serono and MHRA consultant.

From a regulatory standpoint, it is the sponsor which is held accountable if any contractor fails to comply to any GxP regulated activity, Amer Alghabban, Managing Director of consultancy firm GxP Compliance & Training Partners, reminded delegates at the Global Pharmaceutical Contract Manufacturing (GPCM) conference in London last month.

Therefore, compliance audits of third-party producers are essential to assure the quality of a product and ensure supply especially in qualification and selection of a partner, he continued. Furthermore, if carried out and used appropriately they can benefit a contract manufacturing organisation (CMO) as well by avoiding any unexpected surprises from regulatory inspections.

“For a CMO, an audit from a customer can pull up issues and discover gaps and non-conformities. However, a CMO can correct these and thus such an audit from a client is better than one from the regulators that results in a 483 or warning letter, as, at worst, it will lose one client rather than all,”​ Alghabban explained.

Furthermore, an audit allows a CMO to demonstrate abilities unknown to the sponsor and may lead to new contracts or a closer, strategic relationship, he said, citing his own experiences as Director of Quality Assurance and Auditing at Merck Serono, 

Alghabban – who has also been on the other side of the auditing fence, having worked at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) – continued to say that even CMOs who had received US FDA 483s or Warning Letters were far from being blacklisted by current or prospective pharma clients.

“Why wouldn’t [a sponsor] touch them again? If [the CMO] has done a wonderful CAPA on it and improved it, why go to someone who hasn’t experienced the problem yet,”​ he said, adding “we all make mistakes.”

Always show your working

An audit is one of the latter stages in commencing or renewing a contract with a CMO, and Alghabban also spoke about the initial stages of attempting to select a manufacturing partner from the thousands available. Unless requirements are rare or unique, thus immediately limiting production options, the challenge for the sponsor is completing a comprehensive and fully objective selection process.

Before filtering a list of potential CMOs down to an auditable number, a sponsor should have a list of anything up to 50 firms whittled down in a prescreening process incorporating information gathered from conventions, past experiences, and word of mouth, Alghabban said.

“Prescreening is essential,” ​he said, and “most companies either skip this part, as they say it takes time, or do it without actually documenting it.”​ However, he warned, if there is no documentation it has not been carried out, as far as the regulators are concerned.

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