European Commission Passes Act on GMPs
The European Commission has passed an act detailing how good manufacturing practices (GMPs) apply to medicines that require marketing authorisations. Adoption of the supplementing directive provides member states with principles and guidelines regarding their GMP responsibilities.
The directive is designed to ensure conformity with GMPs by laying down detailed provisions for inspectors and placing obligations on manufacturers. Responsibilities placed on manufacturers by the directive cover personnel, premises, documentation and quality control.
To comply with GMPs, each drug manufacturing and import site must have “sufficient number of competent and appropriately qualified personnel” to run effective pharmaceutical quality systems.
Member states are responsible for ensuring manufacturers have effective quality systems. Senior managers are expected to play an active role in these systems.
The quality control system must be under the authority of an employee who is independent of production. Manufacturers must ensure this employee can access at least one adequately staffed and equipped quality control laboratory. Contract laboratories are acceptable.
Another section deals specifically with outsourced operations. Member states must ensure marketing authorisation holders have written contracts with all third-party manufacturing and import operations with which they work.
“The contract shall clearly define the responsibilities of each party and shall define, in particular, the observance of good manufacturing practice to be followed by the contract-acceptor,” the Commission wrote.
Member states are responsible for ensuring companies adhere to these requirements but the Commission also expects the businesses to inspect their own operations. These self-inspections must take place repeatedly to keep track of the state of the pharmaceutical quality system. If needed, the manufacturer should undertake corrective or preventative actions based on its findings. The Commission expects manufacturers to keep records of the self-inspections.
The requirements set out in the document will be familiar to many manufacturers. However, as the GMP inspection records of companies based in Europe and elsewhere show, consistent compliance is a struggle for some manufacturers.