To avoid misunderstanding, a glossary that defines keywords, acronyms and abbreviations is essential. It is essential that everyone knows what is meant by any term used in the quality agreement. This is especially true when contracts with non-U.S. companies. terminology can be very different. Make sure you clearly define all referenced documents. 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. The FDA Quality Agreements document is based on ICH Q10 Pharmaceutical Quality Systems, which states that the owner is ultimately responsible for ensuring that “processes are in place to ensure the control of outsourced activities and the quality of the equipment purchased.” The recommendation is that the owner become quality management when assessing the suitability and competence of potential contractors prior to outsourcing through audits (or other qualification criteria) and regularly assessing the performance of “accredited” contracting bodies. 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. According to the FDA, a communication plan explaining how production deviations are outlined by the CMO to the drug owner and how such anomalies are investigated, documented and resolved should be included in an agreement.