Whenever a contractor or ORGANISATION is used, including agreements between different departments of the same company, regardless of the physical location of the parties involved, a quality agreement should be reached. The agreement should cover all aspects of the project affecting the identity, quality, safety, efficiency and purity of a product. Items that may affect the contractor`s or client`s compliance status should also be included. iv. Manufacturing activities – documentation of the quality unit and other activities related to manufacturing processes, and control of changes in manufacturing processes iii. Resolving differences of opinion – to explain how the parties will resolve disputes over product quality issues or other problems, while quality agreements can cover the full range of pharmaceutical development and manufacturing, we will focus on the laboratory for this column. As part of this discussion, the concept of a laboratory for a laboratory company will be applied to regulated analysis either during research and development or in the manufacturing phases of a drug`s life, including cases where all manufacturing and testing is outsourced to a contract manufacturing organization (CMO), where all analysis is outsourced to a contract research organization (CRO) or a test laboratory. , or that only specialized trials are outsourced by a company. Indeed, there are specific laboratory requirements that are discussed in FDA guidelines (1). A quality agreement is developed in the first place by representatives of quality control or quality assurance of the various parties and it is not always possible to seek legal advice. However, there are a number of legal issues that need to be known when developing or reviewing a quality agreement. The FDA encourages contract manufacturing parties 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. The guidelines encourage homeowners to verify and approve most changes before being implemented. But in certain circumstances, there are changes that contractors can implement without notifying the owner. A quality agreement must determine how all these changes are made and managed. In the eyes of the FDA, any activity that is not documented may as well not have occurred. A quality agreement gives the contracting establishment and the owner the opportunity to define the expectations of those who verify and approve quality documents. Protocols should be described for changes to standard operating procedures (SOPS), manufacturing documents, specifications, validation documentation, and all other essential documents relating to products or services provided by the contracting body. The role of both parties in the development and maintenance of original documents or authentic copies compliant with the CGMP must be indicated.
The agreement should also clarify how these recordings are easily made available for consultation. It is advantageous to include a statement indicating that electronic records are stored in accordance with CGMP and kept in a searchable condition during the required registration periods, in accordance with FDA requirements. 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. In almost all cases of outsourcing of BMP`s activities, there will also be a trade agreement covering outsourced activities, such as a “manufacturing and procurement agreement,” for example.B.