The customer must receive a complete copy of the documentation of the batch containing: – Registration of the production batch – Registration of the packaging batch – Analysis results for each batch – In-process production control record – In-process packaging control registration – Nomenclature (BOM)- Certificate of analysis for the final productA gmp technical agreement is a powerful tool to maintain the quality of the product and maintain a strong Establish an employment relationship between the client and the acceptor of the contract. This master document template for contract manufacturing in technical quality, which is more than 35 pages long, clearly defines the obligations of the customer and the order acceptor and is extremely advantageous for both parties. The template sets out all the agreements, understandings and controls necessary to avoid misunderstandings that could lead to a product or work of unsatisfactory quality. This out-of-the-box template requires only a small amount of site-specific changes before it can fully apply it to your operation. All you have to do is enter your location-specific information into the colored fields that are highlighted. The customer defines the appropriate storage conditions such as temperature, light and humidity for finished products and bulk materials. The contract manufacturer may be asked to transport the products to the customer or to a designated third party. The type of waste (e.B solvents, toxic waste, etc.) and their specific disposal methods are also specified in the GMP Technical Agreement, which the Contractor is obliged to comply with. Make sure your technical agreement includes all cGMP regulations that apply to the manufacture of a particular product. – Active and excipient raw materials must be purchased in accordance with the “Guidelines to minimize the risk of transmission”.- The contractor must not make any changes to the process, raw materials or formulation without the prior written consent of the customer.- The customer and supervisory authorities must be able to carry out audits and inspections of the relevant processes. Premises and documents.

– The entrepreneur may not subcontract any of its liabilities to third parties without the consent of the customer. – Keep records of deviations from predefined procedures or desired test results.- It is the sole responsibility of the Contractor to keep batch records for a defined period of time after the expiration of the product. By defining a clear technical agreement, both sides know who will be responsible for what, thus avoiding conflicts and having defined a clear path of escalation. When inspecting the contract site by the MHRA or FDA, the main question for inspectors is how the parties share responsibility, communicate and confirm GMP compliance. With a well-scripted technical agreement, the subcontractor has a ready-made answer to the investigator. Therefore, it is important to learn how to develop a GMP technical agreement. Ensure that your technical agreement covers all of the following aspects:- Methods and specifications for testing packaging materials- Inspection of packaging materials- Proper labelling methods, review and approval- Packing instructions, operations and documentation- Analysis of finished products and documents before release- Annual product review- Complaint management- Specifications for product recalls and decision of – Product management returned – Pollution prevention The procuring entity should specify its requirements, as the draft technical agreement varies according to these requirements. Some contract manufacturers keep their own standard technical agreement template, but you need to make sure it meets your criteria before signing the document.

A typical technical agreement should include the following elements: In today`s competitive environment, pharmaceutical companies are increasingly outsourcing the production of APIs and formulations. For such cases of contract manufacturing, companies are encouraged to sign the EU Guidelines on Good Manufacturing Practice to sign a technical agreement defining the roles and responsibilities of the respective parties with regard to the manufacture and control of medicinal products. A GMP technical agreement ensures compliance with current Good Manufacturing Practices (GMP). 1. Purpose and scope2. Definitions3. Responsibilities4. Contact list5.

List of products6. Approval7. Amendments and revisions8. List of subcontracting testing laboratories The functions covered by this section include:- Product specification and master formula- Process validation and cleaning validation- Manufacturing instructions and in-process controls- Treatment of process deviations and results outside the specifications- Analysis of bulk materials and storage of reference samples- Specification of the finished product and test methods for finished products- Batch identification system “Under contract” Manufacturing and analysis must be properly defined, coordinated and controlled to avoid misunderstandings that could lead to a product or work of unsatisfactory quality. […] The contract must clearly state how the qualified person who sells each batch of the product assumes full responsibility” (from the European Union Medicines Rules, Volume 4, Good Manufacturing Practices, Chapter 7, Contract Manufacturing and Analysis). .