Who Should Sign Quality Agreement

Posted on December 21, 2020

Iser: In accordance with the FDA`s current guidelines on quality agreements, “quality agreements can be verified during inspections,” and the rules in the United States and Europe, as well as in other regions, include expectations for outsourcing manufacturing activities. Therefore, companies that are audited by a regulatory authority should have all applicable quality agreements so that they can be made available to the examiner/inspector upon request. Sometimes a quality representative or legal counsel suggests that each document be prepared in such a way that it is alone and can be read and interpreted without reference to a second document. While this generally applies to a legal document, it is not the best approach in these circumstances. Overall, the best way to avoid inspection observations that may lead to a warning letter is to initiate quality agreements that use the recommendations of the current quality agreement or outsourcing policies of health authorities, which reflect CGMps and are part of an effective pharmaceutical quality system. A real example of compliance [FDA] 483 in quality agreements is a contract verification body that indicates that it does not comply with a quality agreement on the destruction of the remaining samples with the approval of the contracting entity. This relates to the importance of defining clearly defined roles, respecting roles within an agreement and matching CGMP`s expectations. Quality agreements are also defined in the ICH quality documents. ICH Q7, 16.12, “There should be a written and approved contract or formal agreement between a company and its contractors that specifies the responsibilities of PMPs, including quality measures, for each party.” Individuals who need to know the content of the quality agreement to do their job should be included in the review of the agreement, including business development, project managers and legal projects (to ensure compliance with the delivery agreement). PTE: How can pharmaceutical companies and subcontractors enter into quality agreements that clearly describe the responsibilities of each company? PTE: What are the FDA`s expectations for quality agreements? Iser: There are a number of important aspects to quality agreements between a pharmaceutical company and a contract manufacturer. It is important that the following aspects be clearly explained and agreed upon: as stated in the current FDA [US Food and Drug Administration] Guidelines on Quality Agreements (1), “if all parties clearly understand their roles related to the CGMP and their production responsibilities, owners who use contractual facilities, contract agencies that provide services to owners and, ultimately, patients who take drugs manufactured under these agreements, can benefit in many ways… any party involved in the manufacture of a drug is responsible for ensuring compliance with the CGMP for its manufacturing activities.” This shows how important it is to establish and responsibly define a strong quality agreement. A standard operating procedure should be put in place to indicate the types of creditors and services for which a quality agreement is required.

At a minimum, an agreement must be reached at any time when an OCM is used, as well as with all suppliers of critical materials. They are recommended for suppliers of large quantities of raw materials or components. One of the most overlooked sections of the FDA`s #quality agreement guidelines is the definition section. It is important to know what any term means, especially when contracts with non-U.S. suppliers, says @MCMasterControl bit.ly/2DwrlEC The FDA does not have specific guidelines for quality agreements between medical device companies and CMOs that provide them with services.


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