The client must receive a full copy of the batch documentation containing:- Recording of production batches- Recording of packaging data- Analytical results for each batch of in-process production control control data- Packaging-In-Process-Control Data List (BOM)- Certificate of analysis for the final productThe GMP technical agreement is a powerful tool to maintain product quality and establish a strong working relationship between the supplier and the contract. 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). 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 typical technical arrangement should include the following: Make sure that your technical agreement contains all the CGMP rules applicable to the manufacture of a particular product. – active and excipient-dependent raw materials must be obtained in accordance with “guidelines to minimize the risk of transmission.” The contractor cannot make any changes to the process, raw materials or formulation without the prior written consent of the contracting entity and the supervisory authorities. – the holder cannot delegate his obligations to third parties without the consent of the adjudicator power. – Record discrepancies between pre-defined procedures or desired results.- It is up to the contractor to keep batch records for a defined period after the demage. The contract supplier sets appropriate storage conditions, including temperature, light and humidity for finished and bulk products.
The contract manufacturer may be asked to transport the products to the contract giver or to a designated third party. The nature of the waste (for example. B solvents, toxic waste, etc.) and their specific disposal methods are also described in the GMP technical agreement, which the contractor is required to respect. 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. Ensure that your technical agreement covers all aspects:- Methods and specifications for the examination of packaging materials- Inspection of packaging materials- Appropriate labelling methods, verification and authorization – Packaging instructions, Operations and documentation – Analysis of finished products and documents prior to authorization – Annual product control – Claims management – Product recall specifications and decision to initiate them – Returned product management – Pollution prevention 1.