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

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.”

In chapter 9.2 (Transportation) it 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.

We have seen some Technical Agreements recently that seem to try and by-pass these responsibilities and requirements, particularly in one case – which had been approved in an inspection – where there was no mention of who was the Contract Giver and the Contract Acceptor and a blurring of the responsibilities of the Supplier and transport provider. This, in our view, is bad practice and if adopted on a wider, ongoing basis, will lead to further confusion and a greater risk of inappropriately transported products.

Both parties develop a common understanding of quality. Although contract templates can be and are frequently used, individual particularities should be taken into account and applied as necessary.

Therefore, the content to consider for a Technical/Quality Agreement are as follows:

  • Purpose and scope
  • Quality requirements (e.g. general requirements for the quality system, obligation to perform regular training)
  • Duties of the contract giver
  • Duties of the contract acceptor
  • Storage and transport conditions 
  • Audits (e.g. frequency, the possibility of 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
  • Effective From date