A fully integrated quality management system promotes continuous improvements The FDA encourages parties involved in quality manufacturing to implement quality management practices. These guidelines build on the quality management principles and recommendations set out in the Employment and Quality Guidelines to illustrate key elements of the design and implementation of quality agreements that describe and support manufacturing agreements. A quality agreement should indicate which party will determine the specifications of the components and which party will define procedures for reviewing, qualifying and tracking component suppliers. It is also necessary to determine who will perform the tests or samples necessary to comply with the PMCs. We will continue our analysis of the new guidelines in Part 2 of this article in two parts and will review what it proposes at all stages with respect to change control, product-specific considerations, laboratory testing, documentation and compliance. 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. One element of the CMO`s commitment, which has been hotly debated in the sector, is the quality agreement that, in the new guidelines, “defines and establishes a comprehensive written agreement between the parties involved in drug manufacturing, which defines each party`s manufacturing activities based on how each party will comply with the PMC.” Given that the CMO assumes a much larger share of development responsibility – which is turning into a CDD – many questions have been raised about the content and timing of quality agreements. Indeed, the real usefulness of high-quality agreements has been the subject of debate. Let`s look at the FDA`s new guidelines in this context. On the other hand, in Europe, there is no guidance, but the law that defines what the parties should do in outsourcing activities (2): if a separate contractual laboratory is involved, all relevant roles and responsibilities should be defined. The quality agreement should explicitly state what data is transmitted and how it is disseminated. Note that a quality contract does not absolve the contractor (usually a pharmaceutical company) of responsibility and responsibility for the work performed. A contract laboratory should be considered an extension of the company`s facilities.
Supplier and supplier quality agreements define the quality conditions of materials or services provided at a production site and used in products or product manufacturing. Service quality agreements define the quality conditions of services provided at a production site and used in the manufacture of products. According to the ICH guidelines, risk is defined as a combination of the probability of injury and the severity of the damage1. To manage risk, drug development and production depend on effective risk quality management (QM) – a systematic process of assessing, controlling, communicating and verifying patient risks and drug quality throughout the product lifecycle. Customers who choose to partner with a trusted CDMO for drug development and manufacturing can benefit from a well-established quality policy that handles management, risk management, documentation, change management, CAPA, process performance and product quality.