Quality Agreement For Contract Laboratory Work

Quality agreements are also defined in the ICH quality documents. ICH Q7, 16.12, «There should be a written and approved contract or formal agreement between a company and its contractors that specifies the responsibilities of PMPs, including quality measures, for each party.» «A quality agreement is a comprehensive written agreement between the drug manufacturing parties, which defines each party`s manufacturing activities and determines how each party respects the CGMP. In general, the quality agreement should clearly indicate which party, owner or contracting body, or both, carries out certain CGMP activities. (U.S. Food and Drug Administration [FDA] Guidance «Contract Manufacturing Arrangements for Drugs: Quality Agreements,» 2016.) The above items are included in the delivery agreement. The quality agreement should be a separate document from the delivery agreement, but can be added by reference. Quality agreements and supply agreements are two very different documents. If created in a single document, the list of reviewers will contain many people on either side of the fence who have no real reason or time to check for problems that have nothing to do with their area of expertise. There are regulatory requirements for quality agreements. Although U.S. GMOs are not currently needed for drugs, it is very likely that they will soon. In 2016, the FDA released the policy paper «Contract Manufacturing Arrangements for Drugs: Quality Agreements.» The addition of a quality agreement requirement to 21 CFR 211 would make GPS in the United States compatible with European Union (EU) GSPs and FDA-accepted ich guidelines (see below). Define expectations, roles and responsibilities among stakeholders to optimize validation activities and quality management.1 Note who is doing what. Who`s responsible? What is the expected result? Also be sure to include details of communication channels and expectations.

Everyone is responsible for quality.2 CGMP responsibilities cannot be assigned to a supplier.1 At the beginning of 2013, Chapter 7 of the EU GMP was revised and renamed «Outsourced Activities» to make it more in line with the ICH Q10 drug quality system. The principle of Chapter 7 is: «Any activity that falls under the GMP guide and is outsourced should be defined, agreed and controlled accordingly in order to avoid any misunderstanding that could lead to an unsatisfactory quality product or operation.