SubscribeSomerset House Consultants Discuss the importance of regular GMP audits to prevent pharmaceutical counterfeiting
This article highlights a recent proposal from the European Commission to require mandatory Good Manufacturing Practice audits of pharmaceutical contract manufacturers to prevent product counterfeiting.
Protection of Patients from Counterfeit Medicines
The European Commission has recently issued a public consultation document to invite comments on proposed anti-counterfeiting legislation for pharmaceuticals. This has been an increasing concern for patients, industry and regulators.
A major opportunity for counterfeiting comes from the pharmaceutical supply chain, and the proposed legislation is meant to improve security at all stages of pharmaceutical manufacturing and supply. The proposals involve amendment of Directives 2001/83/EC (medicinal products) and 2003/94/EC (GMP) and will have effects on the Good Manufacturing Practice and Good Distribution Practice guidelines.
GMP Audits to Prevent Counterfeiting
The proposal includes requiring all contract manufacturers and suppliers of drug substances (API), bulk dosage forms and finished packed product to be audited by qualified auditors. At present, manufacturing authorisation holders must use API manufactured in compliance with GMP, and this is usually enforced by the manufacturing authorisation holder carrying out audits. These audit reports are now routinely inspected during regulatory authority inspections. The legislative changes propose that these audits should be mandatory.
Qualifications of GMP Auditors
Personnel carrying out these audits must be suitably qualified, similar to the existing Qualified Person. Many companies have found difficulty scheduling existing audits into the workload of their senior quality assurance staff, especially those of companies outside the EU. One solution is to contract the work out to experienced, specialist audit companies. Somerset House Consultants experienced staff regularly carry out audits of API, dosage form manufacturing, packaging and warehousing contractors and provide reports highlighting GMP compliance issues.