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.” He says these processes should include risk quality management and include critical activities such as.B.: One of the many important details of quality agreements are time slots. If a CMO wants a five-day processing period to verify a master batch (MBR) record, this may be helpful because no data is to be verified. However, if the CMO wants a five-day rotation to verify a batch production dataset (RPO), this is not reasonable in most cases. There is simply too much data to check to be able to do a thorough job in five days. Iser: There are a number of important aspects to quality agreements between a pharmaceutical company and a contract manufacturer. It is essential that the following aspects be clearly explained and agreed: all activities under the quality agreement must be carried out in accordance with the GMP regulations in force. In the guide to the quality agreement (1), the FDA states that contract laboratories are subject to GMP regulations and presents two specific scenarios. You can find them here in a preview, see the instructions for detailed discussion. #Quality agreements can save a company #lifescience a lot of time and money by avoiding misunderstandings, but only if the agreements are concluded in a timely, in-depth and with contributions from all parties involved, @MCMasterControl bit.ly/2DwrlEC PTE says: What are the FDA`s expectations for quality agreements? One of the most overlooked sections of the FDA guide is the definition section. It is essential that everyone knows what is meant by any term used in the quality agreement; especially for contracts with non-U.S. companies, the terminology can be very different.
Insert abbreviations and acronyms and set documents – one person`s data sheet is another person`s data sheet. Define “outsourcing” and if and when it is acceptable. A real example of compliance [FDA] 483 in quality agreements is a contract verification body that indicates that it does not comply with a quality agreement on the destruction of the remaining samples with the approval of the contracting entity. This relates to the importance of defining clearly defined roles, respecting roles within an agreement and matching CGMP`s expectations.