Telf: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. Data security measures should be at least equivalent to those applied in earlier phases of the data lifecycle. Subsequent changes to the data (e.g. B through an IT helpdesk or database changes) should be controlled by the pharmaceutical quality system, with appropriate segregation of duties and authorisation procedures. Data integrity enables good decision-making by pharmaceutical manufacturers and supervisory authorities. This is a fundamental requirement of the pharmaceutical quality system described in Chapter 1 of the EU-GMP, which applies to both manual (paper) and electronic systems. 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. Manufacturing licensees sometimes confuse the role of control authorities with their own obligations, but where inspection reports or GMP certificates issued by European Economic Area (EEA) partners for the Mutual Recognition Agreement (MRA) or other approved authorities are available, they can provide useful information to manufacturing licensees.
Companies wishing to develop combination products should consider the impact of the current 21 Rules of Part 4 (9) on their quality system and operation, and are encouraged to read the current FDA Guidelines on GMP Requirements for Combination Products (4) for more information, as the Guidelines contain language for entering into quality agreements, “Quality agreements, for example, indicate expectations, which organization will perform which activities, and develop and maintain the necessary documentation to prove compliance with certain CGMP requirements. For example, an owner may enter into a contract for the manufacture of the final combined product with a control manufacturing system and describe in detail, in supplier agreements, CGMP`s responsibilities and approaches for that facility. Robert Iser, Vice President of PAREXEL Consulting, spoke with Pharmaceutical Technology Europe about the role of quality agreements in outsourcing. A compliant pharmaceutical quality system generates and evaluates a significant amount of data. While all data has a general influence on GMP compliance, different data have different effects on product quality. Where a manufacturer of a medicinal product receives a serious complaint about the quality of the medicinal product itself or of the packaging components, the system should allow for the identification of the bottles concerned and, if necessary, the recall of the bottles concerned from the market. Yes. The principles of risk quality management may be applied when verifying electronic data and verification by way of derogation shall be permitted if scientifically justified. All actors in the supply chain play an important role in the overall integrity of data and in ensuring product quality. Iser: There are a few common mistakes that occur when companies establish quality agreements.
First, the roles and responsibilities of the pharmaceutical company and the contract manufacturer are not always clear, especially when it comes to explaining and agreeing on the responsibilities of the quality unit. . . .