Sections, or subsections, of the QAG may require rewording, and sometimes a simple change of semantics may eliminate stumbling
blocks in the negotiations. At other times, however, a change of language may be thought to alter the content substantially,
and the sponsor or contractor may not be willing to make the modification. In such circumstances, further negotiation is required.
Patience during initial efforts usually pays off in the long run, as extensive effort may be needed later on to correct mistakes
made during the early negotiation process. The review process may begin via e-mail or fax, but at some point spoken negotiation
will be required. In some cases a teleconference, coupled with Webex, may be a good option. Video conferencing, when available,
might be sufficient to finalize QAG negotiations; however, final execution usually requires that representatives for both
parties meet face-to-face to conclude the agreement. Although this meeting will not guarantee that conflict never surfaces,
it can lower the probability. In some cases, a face-to-face negotiation is the only way to resolve some disagreements.
It is essential that a company put the final negotiated QAG draft through the legal review process; failure to do so can
expose the company to potential liability. Often this review takes places when the business contract, to which the QAG has
become an appendix or schedule, is reviewed. Just as qualified quality personnel should lend their expertise in the creation
of the quality agreement, so must qualified legal counsel review the document with attention to potential liability as a result
of the language used.
When a QAG is a stand-alone document and a company-approved format or template does not exist, the sponsor would be wise,
once agreement has been reached between sponsor and contractor, to have the negotiated QAG undergo qualified legal review.
In the event that a company template has already been approved by a company's quality and legal departments, the legal review
is less critical. Nonetheless, it is still highly advisable to have the finalized QAG undergo legal review, especially to
determine if any additions or deletions to the template could potentially cause legal liability to the company.
There should be a clear understanding by legal counsel of their role and function in the review process. When this understanding
exists, the legal review process is likely to be relatively quick and not a stumbling block. It is important to note that
a lack of such an understanding can cause unnecessary delays in finalizing QAGs, especially when they are stand-alone documents.
Legal personnel should not interpret GMPs nor change the context, unless there is a clear indication of language that can
cause liability to the company in meeting the responsibilities of the agreement. They are not to write the QAG but are to
look at it from a legal perspective to provide protection to the company. For example, ambiguous language that may create
future difficulties can be mitigated in a proactive review by legal counsel. When the QAG is a stand-alone agreement, it is
particularly important to bring it to legal counsel's attention for review.
The legal review process is intended to protect the company from potential liability as a result of the agreement. It is not,
however, intended to change language, agreed to by both parties, that poses no liability threat to the company. It is also
not intended to justify its existence by inserting unnecessary legal terms that may be intimidating to the sponsor or contractor.
Conflict costs money! Far too often, easily preventable situations grow into irreconcilable differences between a sponsor
and contractor that fail to benefit either party. Putting a sound QAG in place at the start of the business relationship can
prevent later problems.
The lack of a QAG that covers areas such as deviation management and change management can lead to misunderstandings and conflicts.
Formal agreements with contractors not only make good regulatory sense in ensuring GMP compliance, they also make good business
sense and can potentially save the sponsor time and money. QAGs are, thus, an effective bridge to a successful future for
companies in the pharmaceutical and biopharmaceutical industries.
Roby P. Blasini is a corporate consultant at a multi-national pharmaceutical company. Tel: 317.730.3129, email@example.com