Are Quality Agreements Required

One of the ways in which each role is exercised is to define it in the agreement, which can be literally. An alternative is the use of a RACI matrix (very “racy”) that is responsible, responsible, consulted and informed. This approach defines the activities participating in the agreement and assigns the corresponding activity for each role. For example, the release of the lot would be within the jurisdiction of the sponsor`s quality unit in the United States or the qualified person in Europe. If these two agreements contain provisions relating to the same purpose, they must be carefully considered if one of the agreements is amended at a later date. A number of resources are available for those who wish to learn about quality agreements: Robert Iser, Vice President of PAREXEL Consulting, discussed with Pharmaceutical Technology Europe the role of quality agreements in outsourcing. 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. In May, the Food and Drug Administration (FDA) released a new draft industry guidelines entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements” (1). I like the way the title rolls out of the tongue, don`t I? You may be wondering what this has to do with spectroscopy, or even an analytical laboratory, which is a fair question.

The answer is on page 1 of the document, which defines the term “manufacturing,” including processing, packaging, breeding, labelling, control and operation of the “quality unit.” Is the light bulb already on? The testing and operation of the quality unit – could these terms mean that a laboratory is involved? Yes, I do. 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. 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.