Installation Qualification cleaning process

Quality systems require that facilities and equipment should be appropriate to the activities undertaken. Surfaces that are easy to clean and maintain in hygienic condition are a requirement in many situations. For example, cloth-backed chairs would not be acceptable in a laboratory that handled potentially biohazardous materials. Equipment should be checked at installation to demonstrate that it can perform its desired function. This is frequently done using an Installation Qualification, Operational Qualification and Performance Qualification (IQ /OQ/PQ) commissioning process. Routine maintenance and calibration programmes are then required to ensure that equipment continues to deliver the specified performance. [Pg.25]

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. [Pg.35]

Installation qualification Operational qualification Cleaning validation Ranging studies PLC qualification Process validation... [Pg.316]

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. [Pg.295]

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... [Pg.1587]

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... [Pg.33]

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. [Pg.520]

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. [Pg.305]

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... [Pg.768]