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.
