Gmp Agreement Template

In today`s competitive environment, pharmaceutical companies are increasingly outsourcing the production of APIs and formulations. In such contract manufacturing cases, the EU`s GUIDELINES on Good Manufacturing Practices encourage companies to sign a technical agreement defining the roles and responsibilities of the parties concerned with regard to the production and control of medicines. A GMP technical agreement ensures compliance with current good manufacturing practices (CGMP). By establishing a clear technical agreement, both sides know who will be responsible for what, what will avoid conflict and have clearly defined the path to escalation. During the MHRA or FDA inspection of the contract site, the inspectors` main question is how the parties share responsibility, communicate and confirm the GMP`s compliance. With a well-written technical agreement, the contract manufacturer received a prepared response to the investigator. It is therefore important to learn how to write a GMP technical agreement. The client should indicate his requirements, as the structure of a technical agreement varies according to these requirements. Some contract manufacturers keep their own model for a standard technical agreement, but you need to make sure it meets your criteria before signing the document. A standard technical agreement should have the following: the contract giver should receive a full copy of the batch documentation, contains:- Recording of production batches – Packaging data set- Analytical results for each batch- production-process-recording of control data- Packaging-In-Process-Basic Parts List (BOM) -Certificate of analysis for the final productA GMP technical agreement is a powerful tool to maintain product quality and establish a strong working relationship between the contract giver and the user of the contract. Ensure that your technical agreement covers all aspects:- Methods and specifications for the examination of packaging materials- Inspection of packaging materials- Appropriate labelling methods, control and authorization of packaging, analysis of finished products and documentation prior to release – Annual product control- Claims management- Specifications for product recalls and decision to initiate returned products – Pollution prevention Product.

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