Standard Operating Procedures and GMP
Abstract:A standard operating procedure consists of a set of instructions having the force of a directive, and covering those features of operations that lend themselves to a definite or standardized procedure without loss of effectiveness. In clinical research, the International Conference on Harmonisation (ICH) defines SOPs as "detailed, written instructions to achieve uniformity of the performance of a specific function".
SOPs are key to organizations involved in clinical research—whether pharmaceutical companies, sponsors, contract research organizations, investigator sites, ethics committees or any other parties—to achieve maximum safety and efficiency of the performed clinical research operations. Good Clinical Practices or Good Manufacturing Practices arises out of these SOPs. The risk of GMP non-compliance is high, where detailed SOPs are not available for reference. SOPs need to be updated regularly to ensure compliance. Regular training of staff will result in they appreciating the importance of SOPs and their role in meeting compliance requirements while manufacture and testing of drugs.
