A Model for Pharmaceutical Supply Chain Quality Agreements
By Rafik H. Bishara, Steve Jacobs, and Dan Bell
The Evolution of the Quality Agreement
More than a decade ago, the way business was conducted between pharmaceutical manufacturing companies and their supply chain providers was typically expressed through verbal expectations at the due diligence meeting, at the audit, or at the first project meeting, and they were pretty much done by written bullet points.
Today, successful sponsor companies regard the vendor company as a partner. Experienced sponsors expect their partners to be a part of their team. The expectation is that they will guide them in areas where their team members are new, inexperienced, or still learning.
Sponsors and vendors learned that one of the better ways to succeed was to clearly establish project expectations and put them into a Master Service Agreement between both parties. As the MSA became more popular, legal departments became part of MSA process. In order to avoid liability, the vendor became less of a partner and more of a business associate looking to avoid legal action and liability.
Addendums to the MSAs were written to avoid having separate MSAs for each project. These eventually morphed into what would be called the Technical Agreement. The parts of the Technical Agreement included, but were not limited to, purpose and scope, definitions, responsibilities, contact list/points of contact, list of products/components, approval process, changes and revisions, and a list of subcontract laboratories/manufacturing companies.
The challenge of any agreement between sponsors and their vendors was the number of people involved in the process execution. Understanding roles and responsibilities, expectations and deliverables, created many issues and delays. The Quality Agreement evolved to fill these gaps and address these challenges.