Editing Process Qualification Template into Protocol

Process Qualification Template Introduction.

Prior to process qualification template being started, all manufacturing equipment, tooling, any instrumentation that is used to assess or measure a parameter, any utility that is used or could make contact with the product, must be qualified using the standard validation protocols such as DQ, IQ, OQ & PQ, along with the associated VMP, URS, VRA, and VP.

At all stages in the process qualification template, staff must be working from detailed documented SOP’s. Each production process must be validated, and so must all the equipment used in the execution of these stages. Caution must be used to ensure that all this equipment is adequately labeled and supported by completed company approved validation and calibration documents and protocols.

Supporting operations such as cleaning and or sterilization of equipment, and sanitation of premises, must be validated and executed in accordance with an approved SOP. Similar attention must be given to ensure that staff have been trained for their allotted tasks and training records are available to confirm this. The validation of the process is carried out by manufacturing three batches of the product that have completed this process qualification template stage, using the production process SOP’s.

Evaluation of these batches dictates whether you have, or have not, a process that is deemed to be under control.

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Process Qualification Template Scope.

Before reaching the conclusion that process qualification template has been successfully completed, it is necessary to demonstrate that the specified process has not adversely affected the finished product. Where possible, product process qualification template testing should include testing under conditions that simulate actual use. Product process Qualification testing should be conducted using product manufactured from the same type of production equipment, methods and procedures that will be used for routine production. Otherwise, the qualified product may not be representative of production units and cannot be used as evidence that the manufacturing process will produce a product that meets all the pre-determined specifications and quality attributes.

Process Qualification template Hardware

All components in the process system combine to control and execute the process  qualification to the required standard, resulting in the output from the system meeting the required quality standards.

This testing normally involves knowing the quality of the input to the system and knowing the required quality of the output of the system. This testing must be performed over the intended operating and alarm ranges for the specific processes. Process Qualification template testing of qualified utilities, typically for microbiological and chemical purity, must be completed as described in QS 809.

For a new system, validation must be done for the entire system. For modified systems, at a minimum, the most distant point of the distribution loop must be tested, as well as the use point immediately before and after the modified use point.

The next sections examine each facility and utility system individually to identify specific requirements that must be included in the design and will be confirmed as part of the process qualification template.

PROCESS QUALIFICATION TEMPLATE