The use of contractual agreements is a well-established business practice, but their use in the pharmaceutical sector is a fairly recent phenomenon. Their implementation is further complicated by the regulatory framework of the industry. Advance agreement to terms and conditions of the relationship is not only a concern of regulatory bodies but is advantageous to the companies themselves. QAGs are useful documents from a business perspective as well as from a GMP perspective. To establish successful business relationships and avoid misunderstandings, GMP responsibilities among all parties can be established in a QAG.
DEFINITION From a legal perspective, an agreement can be defined as an expression of assent by two or more parties, to the same conditions. A quality agreement can, therefore, be defined as an arrangement between two or more parties with respect to the quality responsibilities of the participants, with the business objective being a service or product supply. From the European Medicines Agency (EMEA) perspective, a QAG is also referred to as a technical agreement.BACKGROUND In the EU, QAGs or technical agreements are not only an expectation but a requirement — one that is regulated by legislation such as Directives 2003/94/EC1 and 91/412/EEC,2 and in the European Union GMP Guide.3 The terms "contract giver" and "contract acceptor" are widely used in the EU. In the US, however, QAGs are an expectation, but not a requirement, of the Food and Drug Administration (FDA). While FDA has neither specific guidelines for QAGs in the pharmaceutical and biopharmaceutical industries nor a final rule on the subject, expectations of having implemented QAGs are now relatively common, and violations4 have been recorded. In the US, the contract giver and contract acceptor are usually referred to as "the sponsor" and "the contractor" (contract laboratory, contract manufacturer, raw material supplier, etc.).
SCOPE The company implementing a quality agreement should begin by considering its scope. The QAG should specify the product(s) or service(s) for which it is intended. For instance, a QAG with a biologics active pharmaceutical ingredient (API) manufacturer might include all aspects (cell banks, fermentation, and purification) of the production of an API, as well as its release testing (but not its stability testing). A QAG with a supplier may apply to only one item or to multiple items. A QAG with a stability storage facility may include only the receipt, storage, and shipping of samples, but not any testing.