Duties of a Qualified Person
Article 51 of Directive 2001/83/EC defines the duties of the Qualified Person (QP). Additionally, sections 5.1 to 5.12 of the 'Code of Practice for Qualified Persons in the Pharmaceutical Industry' provides information on the routine duties of a QP.
This can be found in the 'Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002' ( please see the 'Guidance Notes' section for details of how to obtain this publication).
The duties of a QP include:
- ensuring that Good Manufacturing Practice (GMP) has been adhered to
- the requirements of the product registration and of the manufacturer’s licence have been met
- manufacturing and testing processes have been validated
- all necessary quality control checks and tests have been conducted
- the legal requirements for imported products have been met. For products imported from outside the European Union (EU) or European Economic Area (EEA) the QP should ensure testing within the EU/EEA to requirements of the product registration and any other tests to assure quality of the products, unless a Mutual Recognition Agreement exists between the EU and the third country concerned.
The QP is responsible for the release for sale of the finished product and must certify the release of each batch.
Requirements for eligibility of the Qualified Person
The QP must be resident within the UK. Articles 49 and 50 of Directive 2001/83/EC define the requirements for eligibility. The requirements are stringent and legally binding.
Transitional arrangements for those currently carrying out the duties of a Qualified Person'
Grand-parenting arrangements will be put in place to help the sector meet the eligibility requirements for QPs. Guidance Note: 'Traditional Herbal Medicinal Products Directive – Transitional Qualified Persons' , explains transitional arrangements for those who are currently performing the duties of a QP for relevant products.
Article 52 of Directive 2001/83/EC requires Member States to ensure that the duties of QPs are fulfilled, either through administrative measures or by making such persons subject to a professional code of conduct. The MHRA will ensure that the duties of QPs are fulfilled largely by routine inspections.
