Operational qualification cleaning validation

Installation qualification Operational qualification Cleaning validation Ranging studies PLC qualification Process validation... 

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. 

The lyophilizers are cleaned using a validated clean-in-place (CIP) cycle using hot WFI. After the cleaning process, a validated sterilization cycle is mn. The qualification of the steam sterilization cycle was performed during the operation qualification (OQ) of the lyophilizer. 

Scale-up ensuring that installation qualification, operational qualification, performance qualification (IQ/OQ/PQ) activities are properly conducted These include cleaning validation, process validation, sterilization validation, and so forth, according to established corporate procedures. 

Equipment—proper design and sizes for the project, use and cleaning records, documentation to show proper installation and operational qualification (equipment qualification EQ), and in some cases performance qualification documents, validated computer systems, preventive maintenance program, records of equipment repairs and upgrades and subsequent requalification documentation, etc. 

Design Qualification (DQ) is the first validation element of a new facility system or equipment, where adherence to the user s specifications and to GMP rules is demonstrated. Installation Qualification (IQ) follows with the verification of adequacy of the area, installation of equipment pipelines, utilities, instrumentation, and conformity of the material used to the project specifications. At the Operational Qualification (OQ) phase, carried out after installation of all equipment, it is verified whether the system, when in operation, complies with the acceptance criteria defined in the validation plan. Once the OQ phase is successfully finalized it is possible to proceed with the calibration procedures, operation and cleaning, operator training, and preventive maintenance program. After IQ and OQ are concluded, it is time for the Performance Qualification (PQ), with the aim of verifying that what was designed, built, and operated results in a product that meets the expected specifications. Production and QC personnel are specially trained for these assessments. The tests can be done with the product of interest or a placebo, and are related to all operations, from raw material reception to product release (EC, 2001). 

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. 

Cleaning validation is a type of process validation, and the principles of process validation apply equally to a cleaning process. This includes installation qualification (IQ), operational qualification (OQ), and... 

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... 

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