By defining a clear technical agreement, both sides know who is responsible for what, thus avoiding conflicts and have defined a clear path of escalation. During the MHRA or FDA inspection of the contract site, the inspectors` main question is how the parties share responsibility, communicate and confirm GMP compliance. With a well-written technical agreement, the contract manufacturer has a prefabricated response to the investigator. It is therefore important to learn how to establish a GMP technical agreement. Make sure that your technical agreement contains all the cGMP rules applicable to the manufacture of a particular product. – active and adjuvant-bound raw materials must be purchased in accordance with the `Guidelines to minimise the risk of transfer`. – The Contractor may not make any changes to the process, raw materials or wording without the prior written consent of the Contractor.- Contractors and regulatory authorities should be allowed to carry out audits and inspections of the relevant processes. Premises and documents. – the contractor may not sub-assign any of its responsibilities to third parties without the agreement of the contracting entity. – Record deviations from predefined procedures or desired test results.- It is the contractor`s responsibility to keep batch records for a set period after the product expires.
There are four types of quality agreements: manufacturing, supplier, supplier and quality of service agreements, each tailored to the relevant aspects of each type of relationship. A quality agreement is a comprehensive document that defines both specific quality parameters for a project and the party responsible for executing those parameters. The level of detail of a quality agreement varies depending on the development phase of the project. Ensure that your technical agreement covers all of the following aspects:- Packaging material control methods and specifications- Packaging material inspection- Appropriate labelling, verification and authorisation methods- Packaging instructions, procedures and documentation- Analysis of finished products and documents prior to publication- Annual product review – Management of complaint specifications for recalls and product decisions, if e- Management of returned products- Pollution prevention The contracting authority defines appropriate storage conditions such as temperature, light and humidity for finished products and bulk goods. The manufacturer of the market may be asked to transport the products to the client or to a designated third party. The nature of the waste (e.g..B solvents, toxic wastes, etc.) and their specific disposal methods are also described in the GMP Technical Agreement, which the contractor is required to comply with. Quality agreements help both parties in the overall contract analysis process. They define, establish and document the roles and responsibilities of all parties involved in the process. Quality agreements allow each party to set its expectations and rules for projects and ensure that the quality characteristics of both parties coincide and that each party receives effective quality services and products. . . .
