Could a change of ownership be relevant to GMP?

The subject line asks whether a change in the ownership of a pharmaceutical manufacturer could affect GMP compliance. According to the FDA, the answer is yes.

With the initiative ‘cGMP for the 21st Century’, the FDA also adapted its inspection system to be risk-based. At that time, 'recent ownership changes' were mentioned as a criterion for selecting which companies to inspect.

It is precisely this issue that the FDA addresses in a recent warning letter. The company had a poor history of inspections, and a previous warning letter had identified similar CGMP deficiencies in quality control and process validation to those found in the current warning letter.

Despite the change of ownership, the production facility and several executive managers remained unchanged. The FDA concludes that management oversight of drug manufacturing is inadequate, as deficiencies were repeatedly found in several recent inspections.

These deficiencies were communicated to both the previous and current owners. Nevertheless, the company failed to fulfil its quality commitments to the FDA.

The FDA concludes that the quality system is ineffective. The warning letter issues an ultimatum to the management to evaluate manufacturing activities, ensuring that systems, processes and products comply with FDA requirements. In addition, the involvement of a consultant in accordance with 21 CFR 211.34 is recommended – even though consultants are already on site. The consultant should then conduct a 'six-system' audit. This is a requirement set out in the FDA's 2006 guidance document, 'Quality Systems Approach to Pharmaceutical CGMP Regulations'.

In addition, the FDA made it clear in its warning letter that, as a contract manufacturer, the company is responsible for ensuring that the medicines it produces are safe, and that they have their correct identity, strength quality and purity. Hereto, the FDA cites the 2020 guidance document ‘Contract Manufacturing Arrangements for Drugs: Quality Agreements’ once again.

Conclusion: Changes in ownership may also become the focus of an FDA inspection.

You can find the entire warning letter on the FDA website.