Armin Hohenadler

A recent example of a citation of a quality agreement in a warning letter (7) referred to a quality agreement concluded with the company`s contractual manufacturer, which did not contain provisions on the treatment of sterilisation and other provisions of the quality agreement that were not routinely complied with. While this warning letter refers to a device and follows the expectations of the purchasing controls at 21 CFR 820.50 (8), it also shows that clarity of roles and responsibilities and compliance with approved quality agreements are important aspects that must be taken into consideration when a company develops and implements a quality agreement with a contracting body. and can be evaluated while an FDA reviewer is on site. The implementation of a written quality agreement may be in accordance with the CGMP and, in particular, 21 CFR 211.22 (d) which specifies that the activities and procedures of the quality unit must be in writing. The FDA recommends that owners and contract entities enter into a written quality agreement to describe their respective roles, responsibilities, and activities related to the CGMP. Robert Iser of PAREXEL Consulting answers questions about regulatory expectations regarding quality agreements and how companies can guarantee the quality and safety of their products. Iser: There are a number of important aspects of quality agreements between a pharmaceutical company and an order manufacturer. It is important that the following aspects are clearly defined and agreed: they can at any time comment on guidelines online or in writing (see 21 CFR 10.115 (g) (5)) A sufficiently detailed quality agreement can help avoid assumptions leading to conformity errors. While a quality agreement defines the specific quality parameters of a project and which parties are responsible for its execution, the degree of detail varies depending on the development phase of the project.

At least a quality agreement should delineate the obligations and responsibilities of each party in the following basic elements: in the eyes of the FDA, any activity that is not documented cannot have taken place either. A quality agreement offers the contractual establishment and the owner the opportunity to set expectations that verify and approve quality documents. . . .