Validated cleaning processes planned

Berg, T., Humphreys, P., Phillips, B. and Scherz, B., Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation , PIC Publication PH 1/96. 

Validation master plan design qualification, installation and operational qualification, non-sterile process validation, cleaning validation. EU document 111/5581/99. European Commission, Working Party on Control of Medicines and Inspections, Brussels, 1999. 

Validation master plan Specification Risk analysis Design qualification Installation qualification Operational qualification Performance qualification Validation report Process validation plan Process validation program Cleaning validation plan Cleaning validation program Computer validation plan... 

Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-operation Scheme. Recommendations on validation master plan - installation and operational qualification - non-sterile process validation - cleaning validation. PI 006-3. 2007. http // www.picscheme.org/publication.php p=guides. Accessed 4 Sept 2014... 

The other document that the FDA will probably want to review during the course of the PAI is the validation master plan. It is important to note that at the very least a validation protocol must be in place at the time of the inspection (unless it is a sterile product, then full validation must be completed). The validation master plan should cover the cleaning, environmental monitoring, sterilization (when necessary) process, analytical, and computers. The role of validation in PAI has been reviewed in detail by Nash [5]. 

All necessary activities and responsibilities for the qualification and validation are controlled and specified in this Validation Master Plan. Every step of the described validation program for facilities, equipment, processes, process controls, and cleaning is in accordance with the current European Community Guidelines for GMP and FDA, and the cGMP guideline for finished pharmaceutical manufacturers. All requirements in these directives are fulfilled in this validation process. 

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