Quality Agreements Between Pharmaceutical/Biopharmaceutical Companies and Their Contractors - - BioPharm International


Quality Agreements Between Pharmaceutical/Biopharmaceutical Companies and Their Contractors

BioPharm International

STAND-ALONE OR AS PART OF THE SUPPLY/SERVICE AGREEMENT Prior to writing the quality agreement, and to prevent later frustration and avoid wasting time and money, a company should decide whether the QAG will be a stand-alone document or part of the supply agreement or service agreement (business contract). This decision may depend on whether a supply/service agreement is already in place or is being negotiated.

Following the selection and qualification processes (including a quality audit) involved in choosing a supply/service provider, a company that decides to enter into a business contract with a provider should ideally include a QAG as part of the supply/service agreement. A QAG can be prepared and negotiated while the larger supply/service agreement is also being prepared and negotiated. The resulting QAG can then be incorporated into the larger agreement as an appendix or schedule. As such, the QAG will receive legal review when the entire document is evaluated. When the agreements are concurrently reviewed, conflicting information can be identified and resolved more easily and quickly than if the two are reviewed separately.

There are, however, various reasons why a company might implement a quality agreement as a stand-alone document. These include the lack of a finalized supply/service agreement, delays in the revision of a supply/service agreement, and inheriting a supply/service agreement without an existing QAG when licensing a new drug from another company that was using third-party contractors. Irrespective of the reason, if a QAG is to be implemented as a stand-alone document, there should be additional clauses or components (some which will be of a legal nature) in the QAG that are not necessarily included when it is a part of a supply/service agreement.

FORMAT Format decisions are essential. A company may have pre-established templates and thus the format is already selected. In the absence of a pre-established template, the QAG may be legal style, tabular, or a combination of the two. In selecting a format, one must remember that it is not the format that makes a sound QAG, but its content.

Because the quality agreement is the responsibility of the quality assurance function, and because many quality assurance personnel have a scientific or technical background, most companies prefer a tabular format. The tabular structure provides quality assurance personnel with a familiar format by displaying information in a table or graph form, as opposed to the sentences-and-paragraphs structure of the legal-style format. Typically, the tabular format presents the QAG information in a manner that makes it easier for recipients and reviewers to examine tables and find the desired information.

When considering the option of a legal style QAG format, one should take into account the needs of the receiving group, department, or organization, and use a format that is easy for them to read, use, and understand. If the QAG is a stand-alone document, a good compromise for all users is a combination of both the legal and tabular formats, especially a structure that is mainly tabular with some sections presented in legal style format. The legal style sections may include, but are not limited to, signature pages, table of contents, introduction, and disclaimer pages. Obviously, when the QAG is part of a supply/service agreement, much of the information on these legal style pages would already be included in the agreement.

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