Outsourced Activities in the GDP Environment: When is a Contract necessary and what Aspects should be covered?

Recommendation

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Many transport services in the distribution and supply of medicinal products are carried out by external logistics service providers, and also other activities in the GDP environment are often outsourced. In this context, the question arises in which cases it is necessary to sign a Technical/Quality Agreement, which regulatory requirements apply, and which aspects should be covered in such an agreement.

Requirements from the Guidelines on Good Distribution Practice of medicinal products for human use

If a wholesaler wishes to outsource activities to external companies, the requirements of the Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01) must be observed, in which contracts are mentioned in several chapters.

According to Chapter 7 (outsourced activities), a written contract between the contract giver and the contract acceptor, which clearly establishes the duties of each party must be in place. Furthermore, "the contract acceptor should not pass to a third party any of the work entrusted to him under the contract without the contract giver’s prior evaluation and approval of the arrangements and an audit of the third party by the contract giver or the contract acceptor. Arrangements made between the contract acceptor and any third party should ensure that the wholesale distribution information is made available in the same way as between the original contract giver and contract acceptor."

Chapter 9.2 (Transportations) specifies that "where transportation is performed by a third party, the contract in place should encompass the requirements of Chapter 7. Transportation providers should be made aware by the wholesale distributor of the relevant transport conditions applicable to the consignment."

Furthermore, according to Chapter 4.2 (documentation), contracts as part of the documentation (all written procedures, instructions, contracts, records and data, in paper or in electronic form) should be readily available/retrievable.

Requirements from the Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use

In the Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01), Chapter 6.12 is relevant with regard to contracts: "Where storage or transportation of active substances is contracted out, the distributor should ensure that the contract acceptor knows and follows the appropriate storage and transport conditions. There must be a written contract between the contract giver and contract acceptor, which clearly establishes the duties of each party. The contract acceptor should not subcontract any of the work entrusted to him under the contract without the contract giver’s written authorisation."

Of course, as follows from Chapter 4 (Documentation), contracts should be readily available or retrievable.

Content of a Technical/Quality Agreement

By signing a Technical/Quality Agreement, both parties develop a common understanding of quality. Although contract templates can be used for this, individual particularities should be accordingly taken into account.

In general, the following aspects should be considered:

• purpose and scope
• quality requirements (e.g. general requirements for the quality system, obligation to perform regular training)
• duties of of the contract giver
• duties of the contract acceptor
• storage and transport conditions 
• audits (e.g. frequency, possibility of for-cause audits in case of serious deficiencies or deviations)
• provisions for the assignment of third parties
• term of contract
• contact details of relevant persons from the contract giver and the contract acceptor