The FDA encourages parties engaged in contract manufacturing to implement quality management practices. These guidelines build on the quality risk management principles and recommendations set out in the ICH guidelines to illustrate key points in the development and execution of quality agreements that describe and support contract manufacturing agreements. When companies sign the quality agreement, “everyone is happy. It`s like the nuptial couple. But then reality sets in, and although no one is to blame, something inevitably happens,” Minsk commented. Audits are a key mechanism to provide assurance that the contact laboratory meets the requirements of the quality agreement or contract. If violations are detected, they can be remedied before an official inspection. The ultimate goal of your quality agreement: Determine the scope of the project, the expectations of both parties and the ultimate goal of the agreement. This section is essentially the terms of the entire relationship. One of the most overlooked sections in FDA guidelines is the Definitions section. It is essential that everyone knows what is meant by each term used in the quality agreement; especially when concluding contracts with non-American countries Terminology can be very different. Add abbreviations and acronyms and define documents – one person`s batch record is another person`s data sheet. Define “subcontracting” and if and when it is acceptable.
Some regulators around the world may need a quality agreement. But others, such as the U.S. Food and Drug Administration (FDA), do not require quality agreements from medical device manufacturers. The FDA does not have specific guidelines for quality agreements between medical device companies and the CMOs that provide services to them. However, the FDA guidelines state that quality agreements should cover activities covered by Part 820 of the 21 CFR, the Quality System Regulation (QSR) for medical device companies, “where applicable.” Given the inclusion of Part 820 in the Guidelines, a quality agreement between a medical device company and a CMO should take into account the following aspects to varying degrees, depending on the nature of the relationship between the two parties and the goods and services concerned: A quality agreement is not just a set of legally binding rules. It is also an integral part of supplier management and facilitates the establishment of an employment relationship. The process of creating a quality agreement makes this relationship clear: quality agreements are also specified in ICH quality documents. ICH Q7, 16.12, reads: “There should be a written and approved contract or formal agreement between a company and its contractors detailing each party`s GMP responsibilities, including quality measures.” 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. To learn how to optimize the coordination of quality agreements and other contract manufacturing functions with digital tools, read the trend briefing “3 Ways Contract Manufacturing Organizations Are Turning to Digital Technology to Improve Collaboration.” The European Union (EU) paddled across the Atlantic and published a new version of Chapter 7 of the Good Manufacturing Practices (GMP) Regulation, which entered into force on 31 January 2013 (2). The document has been updated due to the need for a revision of the guidance on outsourcing GMP-regulated activities in the light of the International Conference on Harmonization (ICH) Q10 on Pharmaceutical Quality Systems (3). The title of the chapter has been changed from “Contract Manufacturing and Analysis” to “Outsourced Activities” to give the Regulation a broader scope, particularly in light of the current globalization of the pharmaceutical industry. You may also recall in a previous column “Focus on quality” (4), which deals with Annex 11 of the EU GMP on computerised systems (5), that agreements with suppliers, consultants and contractors for services were necessary. These agreements required that the scope of service be clearly stated and that the responsibilities of all parties be defined. At the end of section 3.1, it was also found that IT services are analog (5) – oh my dear! Written contracts or agreements that define responsibilities and communication processes for the quality-related activities of the parties involved are mandatory for “subcontractors” or “outsourced activities”.
In principle, it is the customer`s responsibility to demand the conclusion of such a contract or agreement with its contractors. 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. Privacy: Your supplier may be aware of information about your product or process that is not currently intended for the public, or at least not intended for the public. Use this section of your agreement to make sure both parties know what can and cannot be shared with the public – or competitors. The agreement must not include certain points such as general conditions, pricing and indexation clauses, forecasts, delivery conditions, confidentiality obligations and limitations of liability. These elements belong to the supply contract, which is a separate document. The quality agreement may be incorporated by reference into the supply contract.
If both documents are created as a single document, the approval list may include people who have no reason or time to consider issues that have nothing to do with their area of expertise. Should quality assurance be an integral part of the trade agreement? No. While quality assurance is crucial to the business relationship, it should be a separate or at least separable document (e.B and issuance) from commercial contracts. The FDA does not routinely require or review trade agreements during inspection, but regularly requests and reviews evidence of quality agreements or their absence. If quality assurance is separate, commercial terms are avoided from being shared with the FDA. If a separate contract laboratory is involved, all relevant roles and responsibilities should be defined. The quality agreement should explicitly specify what data will be shared and how it will be disseminated. Who should check quality assurance? Each party`s quality units play a key role in the preparation and review of AQs. These units are best suited to understand all applicable CGMP, SOPs and other applicable requirements of the relationship.
A lawyer may be mandated to review quality assurance at least once to ensure that it complies with underlying trade agreements and other matters of legal or regulatory interest […].