Pharma Quality Agreements: What Are They, and Why They Matter For Your Study

Quality Agreements are an effective bridge to a successful future for companies in the drug development sector – putting one in place at the start of the business relationship can prevent problems later. Quality Agreements mitigate risk and increase collaboration between partners.

These agreements define timelines and establish responsibility and accountability. They supplement contractual commitments. In addition to making good regulatory sense in ensuring GCP compliance, they also make good business sense and can potentially save the sponsor time and money.

Quality Agreements have been utilized in the pharmaceutical industry for many years to describe responsibilities contracted out to vendors providing GMP services like contract manufacturing, packaging, and distributing. Quality Agreements are just beginning to be utilized in the clinical drug development sector to ensure responsibilities are understood by both the contractor and the vendor providing GCP services. Pharmaceutical and biopharmaceutical industries are relying on Quality Agreements more often and the FDA is recognizing the importance to demonstrate proper oversight and compliance. This white paper focuses on the Quality Agreements in the GCP world.

In today’s environment of virtual companies and outsourced drug development, it is important to maintain and demonstrate proper oversight to regulatory authorities. With release of the ICH/GCP E-6 (R2) 2016 addendum, sponsors are also required to demonstrate adequate vendor oversight of CROs, including those sub-contracted to another party by the sponsor CRO(s).  A Quality Agreement is the perfect tool to outline responsibilities and expectations.  A Quality Agreement in the scope of pharmaceutical development is an agreement that is mutually negotiated and concluded between the Quality Departments of a sponsor (Pharma Company) and their vendors (CROs, etc.). It is intended to define responsibilities relative to quality tasks and help ensure the development of safe products. Contract partnerships inevitably have issues and Quality Agreements ensure they’re dealt with quickly and systematically.

Written contracts or agreements defining the responsibilities and communication processes for quality related activities of the involved parties are mandatory for “contract manufactures” or “outsourced activities”. In principle, it is the responsibility of the contract giver to request the closure of such a contract or agreement with its contract acceptors.

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