It is important that these aspects, as well as other recommendations contained in the current guidelines, are taken into account when developing and implementing agreements with contractual entities. Robert Iser of PAREXEL Consulting answers questions about regulatory expectations regarding quality agreements and how companies can guarantee the quality and safety of their products. According to the FDA, a quality agreement is a comprehensive written agreement between the parties involved in the manufacture of the contract, which defines and defines the manufacturing activities of each of the parties with respect to CGMP compliance. The agreement should clearly indicate whether the owner or the contracting entity (or both) performs certain CGMP activities. 1. If a separate control laboratory is involved, all relevant roles and responsibilities should be defined. The quality agreement should explicitly specify what data is shared and how it is disseminated. An effective quality agreement defines the specific sites on which the contracting establishment will carry out manufacturing operations, including specific services to be provided at each site. Whenever a contractor or cMO is engaged, including agreements between different departments of the same undertaking, regardless of the physical location of the parties involved, a quality agreement should be concluded. The agreement should cover all aspects of the project affecting the identity, quality, safety, efficacy and purity of a product. Elements that may affect the conformity status of the contractor or customer must also be included.
A quality agreement is a comprehensive document that defines both specific quality parameters for a project and the party responsible for executing those parameters. The level of detail of a quality agreement varies depending on the development phase of the project. Iser: There are a number of important aspects of quality agreements between a pharmaceutical company and an order manufacturer. It is essential that the following aspects are clearly formulated and agreed: Robert Iser, Vice President of PAREXEL Consulting, discussed with Pharmaceutical Technology Europe the role of quality agreements in outsourcing. The FDA guidelines state (as part of case examples): “No matter who tests the products, the owners` quality units are ultimately responsible for manufacturing the products in compliance with CGMP. A quality agreement will not change that. FDA could cite the owners. because they do not evaluate, qualify, control and monitor their contractual establishments. A quality agreement should contain at least the following sections: The FDA`s current position on quality agreements is contained in the “Contract Manufacturing Arrangements for Drugs: Quality Agreements” guidelines published in 2016.
The guidelines explicitly state that manufacturing activities are the most important element of a quality agreement. It highlights the seven most critical areas that should be the subject of a quality agreement and their specific implications in terms of quality and change control. Do you have quality agreements with your payroll manufacturers, co-workers, payroll labs and component suppliers? If not, we can help you develop and implement quality agreements with your suppliers throughout your supply chain. For information on how Weinberg Group can help your company meet cGMP compliance in the pharmaceutical supply chain, contact us today. PTE: What are the FDA`s expectations for quality agreements? A true example of compliance [FDA] 483 under quality agreements is a contractual control body that is cited for failing to comply with a quality agreement on the destruction of residual samples with the authorization of the contracted company. . . .
10 October 2021 BBP Admin Uncategorized
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