Operational qualification cleaning process

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

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. 

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. 

With over three years invested in the development and qualification of the supercritical cleaning process, the next phase of the implementation plan was cleaning of production hardware. The two key operations which had been identified early on as potential applications were the cleaning of end housings and the removal of bulk amounts of damping fluids from fill system fixturing. 

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... 

Critical processes other than the actual product manufacturing process — such as sterilization, component washing, and equipment cleaning — require prevalidation cycle development work. This may include establishment of appropriate sterilization cycle types, cleaning agents, etc. This test work is performed during or after Operational Qualification. 

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... 

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. 

EU Guide to Good Manufacturing Practice, Draft revised version of Annexl5 Vahdation master plan Design qualification, instaUation and operational quahfication, non-sterile process vahdation, cleaning vahdation. 

A similar qualification, selection, and review process should be instituted for other components of the supply chain, such as distributors, warehouses, terminals, toll processors, transloading locations, and container cleaning facihties. Inherent in this process is the need to ensure these third-party handlers are provided the necessary irtformation about the chemicals they transport, handle, and/or store, and reqirirements to manage their operations safely and securely. 

No visible residue fromcleanable or any activated fluxes is allowed. Production operations may not be required to remove cleanable residues if qualification testing is performed that demonstrates no need for cleaning the assembly. No-clean or low-residue flux chemistries may be allowed during the soldering process. However, it is critical that the cleanliness of the elements such as the bare boards and components be specified, controlled, and closely monitored otherwise, the contaminant build-up can far exceed allowable limits for the end item s functional performance. 

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