Decide if failure investigation strategies are followed. Identify In case the degree to which a top quality issue or nonconforming product or service is investigated is commensurate with the significance and possibility from the nonconformity.It must be implemented. People today have to Adhere to the strategies, plus the strategies must are develop

Repackaging, relabeling, and Keeping APIs and intermediates need to be performed underneath correct GMP controls, as stipulated in this direction, to prevent mix-ups and loss of API or intermediate identity or purity.These records ought to be numbered with a unique batch or identification quantity, dated and signed when issued. In continuous produc