13/14 December 2023
Is senior management really responsible for GMP? Yes, it is! As a recent case from Denmark shows. In the past, authorities in the EU have focused more on Qualified Persons (QPs) to be responsible for quality failures. However in many companies they hold middle management positions rather than senior.
With the ICH Q10 Guideline on Pharmaceutical Quality Systems (PQS) from 2008, a new thinking was supported: to make senior management ultimately responsible to ensure an effective pharmaceutical quality system is in place. This has later been reflected in updates of the EU-GMP Guidelines. Annex 16 (Certification by a Qualified Person and Batch Release) for example states that "The ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the marketing authorisation holder (MAH). However, the QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing authorisation (MA) and with Good Manufacturing Practice (GMP)."
The Danish Medicines Agency (DKMA) has now taken an action that reinforces this senior management responsibility in an interesting way: they demand the replacement of the CEO!
Europharma DK ApS (a repackaging facility in Denmark) was inspected and "serious breaches of compliance with GMP" were discovered, for example deliberately hidden information, falsification of the expiry date on medicinal products, use of contract acceptor without audits etc. This can be found in the respective report on Eudra GMDP.
Consequently, the DKMA partly suspended the company's manufacturing authorisation and GMP certificate. According an article in in-pharma , Danish regulators suggest that the firm needs a new CEO!
Now this should send a clear message to pharmaceutical companies and their senior management about the ultimate responsibility for the PQS.