Eudralex Quality Agreements

Schmitt: Although the promoter outsources certain activities, it retains full responsibility for everything the contractor does when contacting the supervisory authorities. Thus, the responsibility for the manufacture of safe products of high quality remains the responsibility of the sponsor. Therefore, it is in the proponent`s best interest to draft quality agreements that ensure that the contractor maintains high quality and compliance levels. Iser: The FDA issued a definitive industry forecast for quality agreements with contract manufacturers in November 2016 (1). The guideline was developed in collaboration with the Centre for Drug Evaluation and Research (CDER), the Centre for Biologics Evaluation and Research (CBER), the Centre for Veterinary Medicine (CVM) and the Office of Regulatory Affairs (ORA) and outlines the FDA`s current thinking and expectations for quality agreements. It is strongly recommended that companies refer to these instructions when initiating a new quality agreement or when reviewing an existing quality agreement with a contractual body. Iser: The European Commission has published a review of the European Union`s Good Manufacturing Practices (GMP) (Chapter 7) (2) with effect from 2013, in order to provide expectations for subprocessed activities regulated by GMP. The revised GMP guide contains many of the same themes contained in the FDA`s current industry guidelines, including the roles and responsibilities of the client (of the pharmaceutical company) and the contractor (the contracting body), the evaluation of an agency responsible for carrying out outsourced activities, the disclosure of information necessary to carry out the outsourced activities, the expectations for control of changes. Etc. A company wishing to enter into a quality agreement should use this guide. The FDA guidelines also state (in case examples) “Regardless of who the products are tested, the owners` quality units are ultimately responsible for manufacturing the products in accordance with CGMP.

A quality agreement will not change that. The FDA could name the owners… for non-assessment, qualification, review and control of their contractual bodies. PharmTech: What are the parts of the FDA`s quality agreement guidelines published in November 2016 that manufacturers should be watching closely? Are there similar guidelines in Europe? PharmTech: How do quality agreements improve the overall quality of pharmaceuticals? PTE: Do regulators want to see copies of quality agreements during inspections? Robert Iser, Vice President of PAREXEL Consulting, discussed with Pharmaceutical Technology Europe the role of quality agreements in outsourcing. Iser: Although a pharmaceutical company (or an application sponsor or market authorization) is ultimately responsible for making available products available to patients and nurses meeting quality and safety expectations, ensuring the quality and safety of products and ingredients manufactured in a contract facility is a shared responsibility between the pharmaceutical company and each licensed facility. Both parties must meet the expectations set out in the relevant rules and guidelines to ensure that products are manufactured in accordance with current good manufacturing practices (CGFs), meet the required quality standards, and are safe and effective throughout the product lifecycle. Schmitt: Problems are more likely to arise when both parties are not properly coordinated, which can lead to a misunderstanding about expectations. In addition, gaps may arise in some areas where the proponent and contractor have different knowledge, such as information technology.B.

In order to avoid any gaps or conflicting details in an agreement, the contractor and sponsor should maintain a close relationship with clear objectives and mutual understanding of the quality agreement.