Validated cleaning processes aspects

A significant aspect of compliance is validation of the process through qualifications of the equipment installation and operation, process validation and, recently, the development of a cleaning validation. There are summaries describing how to qualify the installation and operation of equipment, piping, valves and instruments [84], The process validation requires evaluating the critical steps, which effect the quality and purity of the final active drug substance [85]. This involves development of a protocol, which states how the validation is to be conducted and defines the data to be collected. The most important part of the protocol is the development of acceptance criteria for the results. 

Automated systems Process validation of unit-operations Cleaning methods Analytical methods Furthermore it must be assured that relevant documentation is up to date and available. If data from Product Quality Review (PQR, see Sect. 35.6.11) and stability testing are available they should be evaluated in order to identify any critical aspect of the processes. If not available related quality indicators, such as test results, deviations and complaints should be evaluated. 

---