This section should have been at the heart of the guidelines, but it has only two paragraphs. One of the main challenges in using a CMO is to define how the quality units of the two organizations collaborate and interact with each other. While it is true that the pharmaceutical sponsor cannot delegate its responsibility for cGMP compliance, the complexity associated with the orientation of a drug sponsor`s (QMS) quality management system to a CMO is palpable. For example, person-in-the-Plant (PIP) is a relationship point where friction can occur between an OCM and a sponsor. The rights and rights of notification, frequency, access and communication are elements that should be clearly defined in a quality agreement. A CMO has multiple clients, and each PIP requires hosting and management, which adds an additional level of organizational management to the CMO`s operation. 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. The ICH`s industry guide Q10 Pharmaceutical Quality System recommends that the owner, as a member of a pharmaceutical-grade system, ultimately be responsible for ensuring that “processes are in place to ensure control of outsourced activities and the quality of materials purchased.” It states that these processes involve quality management and should include critical activities such as. B: 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, there should be a quality agreement. 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. 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.
A reasonably detailed quality agreement can help avoid assumptions that lead to compliance errors. However, while a quality agreement defines the specific quality parameters of a project and the parties responsible for their implementation, the degree of detail varies depending on the stage of development of the project. At a minimum, a quality agreement should define each party`s obligations and responsibilities in the following basic elements: companies wishing to develop combined products should examine the impact of the current 21 CFR articles (9) on their quality system and operation, and are invited to read the current AFP guidelines on LNG requirements for combined products (4) , as the guidelines for the quality agreement contain guidelines. , “agreements.” B quality, for example, can define expectations for establishment or activity and the documentation necessary to demonstrate compliance with certain requirements of the CGMP … for example, an owner may enter into a production contract for the final combination with a custom manufacturing plant and explain in supplier agreements the responsibilities and approaches of the CGMP for that facility. The most common risk analysis tools used in risk management activities are, for example, error modes and effects analysis (FMEA), cause-and-effect matrixes, and thermal maps.