Quality Agreements Between Pharmaceutical/Biopharmaceutical Companies and Their Contractors

Apr 01, 2005
Volume 18, Issue 4

Roby P. Blasini
During the past several years in the pharmaceutical and biopharmaceutical industries, conflicts and misunderstandings have arisen between companies and their contractors. Too often, productive working relationships have crumbled, resulting in expensive production delays with companies and contractors squabbling over their roles and responsibilities. Such conflicts may have their roots in the lack of a sound quality agreement (QAG). QAGs that clearly delineate good manufacturing practice (GMP) responsibilities between a sponsor and a contractor can help companies and their contractors avoid certain conflicts.

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.).

Table 1. Types of Contractors Used in Quality Agreements
TYPES OF CONTRACTORS USED IN QUALITY AGREEMENTS A given company is likely to have QAGs with a number of product and service vendors, such as a contract manufacturer, a contract-release testing laboratory, a distributor, etc. The agreements may be similar in content, even when the vendors are of very different natures, or they may contain subtle or substantial differences, even when the vendors supply similar products or services. Table 1 illustrates only a few of the possible types of contractors used in establishing QAGs.

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.

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