Apr 16, 2022 AUTHOR: pthomas
What Is Technical Agreements
Pharmaceutical companies have outsourced much of their business, such as. B drug development, production of active pharmaceutical ingredients (APIs), drug production, packaging, release of drugs by a qualified person or quality control (QC). These outsourcing activities are often complex in nature and involve significant risks from a business and compliance perspective. It is therefore necessary to conclude technical and quality agreements between pharmaceutical companies (contracting entities) and companies carrying out outsourced activities (contractors). One of the most overlooked sections in the FDA`s guidelines on #quality agreements is the Definitions section. It was important to know what was meant by each term, especially when entering into contracts with non-U.S. suppliers, said @MCMasterControl bit.ly/2DwrlEC If both agreements contain provisions on the same subject, these should be carefully considered if one of the agreements is subsequently amended. The customer must receive a complete copy of the documentation of the batch containing:- Production batch registration- Packaging batch registration- Analysis results for each batch- In-process production control protocol- In-process packaging control protocol- Nomenclature (BOM)- Certificate of analysis for the final productGMP technical agreement is a powerful tool to maintain product quality and a strong working relationship between the client and the contractor. About the authorSiegfried Schmitt, Senior Consultant, PAREXEL International, talks about the importance of quality agreements.
Although QTAs were originally introduced simply as quality agreements, I support the current trend that emphasizes the technical aspect in the title, because quality does not exist in a vacuum, but is an integral part of the process and the product that controls it. Recent updates to the FDA`s guidelines on quality agreements in 2016 focus on commercial manufacturing, but an agreement is expected to be signed for contractual activities with any cGMP environment. For this reason, agreements are negotiated and executed jointly during the CDMO selection process. While established sponsors may insist on using their own MSA and/or QTA, most companies choose to start with CDMO models for a variety of reasons. However, despite their widespread acceptance and available FDA guidelines, there is still some degree of variability between the models. Technical knowledge and general supply chain experience should not be underestimated in the dialogue with any CDMO. In a recent negotiation, a CDMO argued that minor changes that were believed to have no impact on the product or regulations would not need to be communicated or approved by the client to maintain flexibility. We responded that, without client involvement, the CDMO could not unilaterally determine what changes would have an impact, nor could it be fully aware of a client`s regulatory obligations.
This negotiating point showed how important clear and precise definitions can be and what QE should trigger communication. The customer defines the appropriate storage conditions, including 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 nature of the waste (e.B solvents, toxic wastes, etc.) and their specific disposal methods are also specified in the GMP Technical Agreement, which the contractor is obliged to comply with. No wonder: definitions are essential to clarify and qualify key terms used in QQA. What constitutes a change? When is a result, event or result a discrepancy? Make sure that the keywords used in the document are set correctly. Check the accuracy and applicability of each entry in the Definitions section of the AQQ. Depending on the statement of work, deviations may include, for example, out-of-specification results (OOS), but also operating errors, non-compliance with a protocol, unforeseen changes or unforeseen events, etc.
The definition should be clear as to what constitutes a deviation in a GMP context and, if applicable, a non-GMP-compliant parameter. While both sides agree that measures depend on the severity of quantitative easing, qualifiers must also be defined. Often, deviations or changes can be classified as critical, large, minor and other (e.B. “planned”). In this case, each level must be defined in detail and precisely for the project. The contracting entity should indicate its requirements, as the structure of a technical agreement varies according to those requirements. Some contract manufacturers keep their own standard technical agreement template, however, you should make sure it meets your criteria before signing the document. A typical technical agreement should include the following parts: After offering concrete examples of technical changes that appeared to have no impact, but ultimately led to product issues or regulatory filing requirements, we agreed to inform the CDMO PM to the customer`s technical manager during scheduled biweekly calls.
In the project plan, we also committed to having representatives available on site or during critical operations and manufacturing campaigns to be informed of QE in real time. This is a constructive negotiation with the available instruments. A quality agreement clarifies exactly what is expected of both parties and who will be responsible for virtually every aspect of the project. It also identifies specific aspects of project costs and can thus save time and money. In a previous article, I described best practices for trading AMS and SA. I have described the MSA as a document describing the operational, legal and financial framework for the performance of services or the provision of products. I have found that there are several sections within the MSA that relate to the QTA. This article will continue the discussion from the perspective of the Technical Director who will work in the QA framework by describing how MSA and QTA work together and how the ATQ can be negotiated to achieve the project objectives. The above elements belong to the supply contract. The quality agreement should be a separate document from the supply contract, but may be incorporated by reference.
Quality agreements and supply agreements are two very different documents. When created as a single document, the list of reviewers includes many people on either side of the fence who have no real reason or time to consider issues that have nothing to do with their area of expertise. Make sure your technical agreement includes all cGMP regulations that apply to the manufacture of specific products. – Active and alternative raw materials must be purchased in accordance with guidelines to minimise 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 contracting entity and the supervisory authorities should be allowed to carry out audits and inspections of the processes concerned. 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 after the expiration of the product. .