European Commission releases outsourcing guidelines
Cover contracts by EU companies for work within and outside the EU
Pharmaceutical companies have been asked to comment on revised European Union (EU) guidelines on good practice regarding the outsourcing of medicine manufacturing. This covers contracts by EU companies for work carried out both within and outside the EU.
The European Commission’s directorate general for health and consumers (DG SANCO) has released the changed guidelines and wants comments by 28 February 2011.
The new guidelines aim to ensure that there is clarity in any outsourcing agreement and say that the ‘outsourced activities must be correctly defined, agreed and controlled in order to avoid misunderstandings which could result in a product or operation of unsatisfactory quality’.
They also outline two distinct legal roles: a written contract between a ‘Contract Giver’ (the main pharmaceutical company) and the ‘Contract Acceptor’, and this contract ‘clearly establishes the duties of each party’.
These duties must be integrated into the main pharmaceutical company’s quality control systems, and ‘the Quality System of the Contract Giver must clearly state the way that the Qualified Person certifying each batch of product for release exercises his full responsibility’.
Meanwhile, under the guidelines, the contractor ‘must be able to carry out satisfactorily the work ordered by the Contract Giver such as having adequate premises, equipment, knowledge, experience, and competent personnel’.
The guidelines add that the contractor must not sub-contract any work without the main pharmaceutical company’s agreement and the contractor cannot make ‘unauthorised changes’ to the work, ‘which may adversely affect the quality of the outsourced activities’.
The contract should specify respective responsibilities and communication processes. Also, ‘technical aspects of the contract should be drawn up by competent persons suitably knowledgeable in related outsourced activities and good manufacturing practice’.
All records related to outsourcing have to be kept by the main pharmaceutical company.
Comments and suggestions should be sent by email to: SANCO-gmp@ec.europa.eu and ADM-GMDP@emea.europa.eu