Enterprise equipment gmp certification operation steps are as follows:
1, a clear scope of the initial validation, reconfirmation
Provide a list of all production equipment and production process flow, and finalize which equipment need to do equipment validation, and which process belongs to the special process.
2, instrumentation verification
Equipment verification is basically a fixed parameter, can be divided into three steps in accordance with conventional practice IQ, OQ, PQ.
3, the preparation of the program
Development of the validation program, and then the validation of the Engineering Department involved, operators, inspectors and other training.
4, implementation of verification, validation
According to the company's documents, each validation program and report is assigned a document number.
5, instrumentation and equipment verification and re-verification, re-confirmation
Equipment should be verified according to the verification program. When the main factors affecting product quality, such as process, quality control methods, the main raw materials, production to be production equipment, etc. changes, as well as the production of a certain period of time should be re-validated. Generally the following cases need to be re-validated equipment:
(1) equipment or utility systems after overhaul or major changes;
(2) the relevant SOPs have an important modification;
(3) trend analysis found that there is a systematic deviation.