If the person contacted subcontracts part of his work to a third party, this must be included in the agreement – with the possibility of a veto by the developer and the right of review by the owner or contracting entity. In the eyes of the FDA, any activity that is not documented may just as well not have occurred. A quality agreement gives the contractual facility and the owner the opportunity to set expectations as to who reviews and approves quality documents. It shall describe protocols for modifying standard operating procedures (SOPs), manufacturing records, specifications, validation documentation and other essential documents related to the goods or services provided by the procuring entity. The role of both parties in creating and updating original documents or original GMP copies should be clarified. The agreement should also specify how these records are to be made available for inspection. It is beneficial to include a statement that electronic records are stored in accordance with GMP and kept in a recoverable state during the required registration windows specified in applicable regulations in accordance with FDA requirements. ii. Definitions — ensure that the owner and the contracting entity agree on the exact meaning of the terms of the quality agreement Each activity covered by the GMP Guidelines and outsourced should be adequately defined, agreed and monitored in order to avoid misunderstandings that could lead to an unsatisfactory quality product or operation. There must be a written contract between the Contractor and the Contractor clearly specifying the obligations of each party.
The supplier`s quality management system must clearly indicate how the qualified person certifying each batch of the product for release exercises full responsibility. As a rule, there are only two parties to a quality agreement; these are defined as the customer (i.b i.e. the pharmaceutical company or sponsor) and the acceptance of the contract (contract laboratory) in accordance with EU GMP (2). Alternatively, the FDA refers to “The Owner” and “The Contractual Facility” (1). Whatever names are used, there are usually two parties involved in a quality agreement, unless you are the Marx Brothers (the party of the first part, the party of the second part .. the party of the 10th part and so on) (9). . . . .