PROCESS QUALIFICATION (PQ)


Process Qualification / process validation customer city skylines. this one is Los Angeles.

PROCESS QUALIFICATION RATIONALE.

Process Qualification Introduction.

Prior to process qualification 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 validation, 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 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 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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Graphic presentation of the document flow from URS to PQ.

Process Validation Scope.

Before reaching the conclusion that process validation has been successfully completed, it is necessary to demonstrate that the specified process has not adversely affected the finished product. Where possible, product process validation testing should include testing under conditions that simulate actual use. Product process validation 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 Hardware

All components in the process system combine to control and execute the process 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 validation 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 validation.



PROCESS QUALIFICATION.



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Definitive Validation Manual (Issue 3.) -- $1,160.00


This Corporate Validation Manual (CVM) is supplied loaded to a memory stick (MS) and complete with the attachments that are listed in the graphics below. These high quality documents and protocols are all constructed in Microsoft Word. Each document is preceded by an SOP which prompts you through the procedure of populating and then customizing the template, into your own bespoke company document.  This MS has real documents, detailed, compliant and interactive, but most of all - Highly Cost Effective. These documents have evolved through over thirty years of joint validation expertise, they will free up a lot of your time and enable you to deliver your validation projects and tasks on time.
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