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


Quality Agreements Between Pharmaceutical/Biopharmaceutical Companies and Their Contractors

BioPharm International

CONTENT Contractor-specific content is a critical piece of the quality agreement. While much of the QAG may exist in template form, particular requirements may need to be included for certain suppliers. The converse of this is true, as well, for some parts of the template may not apply to a specific supplier; thus, these should be deleted or clarified. Where pre-established templates exist, it is important to remember that no two QAGs are the same and that each business relationship is unique; therefore, a certain amount of flexibility is essential.

Templates should never include content that is etched in stone. Some large companies prefer that different business groups or sites use templates to provide consistency across the organization. While this practice is valuable, the QAG may need to satisfy the unique needs of a particular site or business group; therefore, the template may require additions and/or deletions.

Table 2. Categories in Quality Agreements
The best templates are those that allow for some flexibility, in case, for example, during the negotiation process it is decided that particular language should or should not be included. Those companies creating unalterable QAG templates may encounter problems with suppliers that may not be willing to sign off on such rigid QAG. In addition, experience has shown that such flexibility can be very helpful during contract negotiations.

Table 2 displays categories (listed in alphabetical order, not in order of importance) that should be considered as to their applicability for inclusion in quality agreements. The categories depend on the type of quality agreement, but they are not definitely limited to those presented.

Although the agreement is typically the responsibility of the quality assurance function, when drafting or reviewing QAG content the writer should solicit input from other groups such as technical, procurement, and legal. Throughout the writing, editing, and negotiating processes, it is essential that all parties involved with the QAG bear in mind the purpose and the scope of the agreement. When creating a QAG, the writer should remain focused on the objective and bear in mind that the QAG is neither a supply agreement nor a service agreement. It is, instead, a delineation, for the parties involved, of the GMP responsibilities and the scope of the specific supply or service.

Clarity of language in the QAG is essential. While some legal documents might have a place for ambiguity, QAGs do not. Clearly defined, specific expectations of GMP responsibilities should be described, understood, and agreed upon by both parties to the agreement.

Table 3. A Generic Example of a QAG Tabular Format
Table 3 provides a generic example of a tabular QAG. It shows categories, areas of specific responsibilities, and descriptions of each responsibility. (Under "raw materials," only one example is given in Table 3, although of course others exist, such as raw material specifications, etc.)

NEGOTIATING THE AGREEMENT In large companies it is not uncommon for more than one functional area or project to send outsourced work to a single contractor. In such cases, more than one group may be represented in the QAG negotiations. It is of paramount importance in these instances that internal consensus precedes external discussion. When possible, a single functional unit should speak for the entire company. Most contractors prefer this approach because it lessens confusion that can result from diverse opinions or viewpoints. Nothing is as appalling at the negotiation table than members of the same company disagreeing in front of the potential contractor. This conduct is unprofessional and tells the other party that the company representatives are unable to concur among themselves. Inevitably the contractor will ask, "If they can't agree with each other, how are they ever going to reach agreement with us?"

The negotiation process, which may be relatively easy or extremely difficult, can be viewed as the most critical part of the QAG. Even with the best QAG, negotiations can break down. This is sometimes due to the inabilities of the negotiator. An impressive job title, strong technical ability, solid quality assurance background, or even experience in writing QAG content does not necessarily mean that one has the negotiating skills acquired through experience or formal training. So, if the negotiation process is to be successful, a skilled negotiator is vital.

Once the draft of the quality agreement is ready, it may be shared and discussed by all parties concerned via a variety of means, such as telephone, e-mail, fax, Webex conferencing, video conferencing, and face-to-face meetings. Conflicts and delays during the negotiation process can cost tens (if not hundreds) of thousands of dollars, so adequate planning is a proactive best practice. At the same time, the process should not be rushed. Close attention should be paid to specifics of a QAG during negotiations.

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