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.
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.
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.
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combination IQ-OQ-PQ protocol has been produced in response to several hundred reader
suggestions we received in our ‘Suggestions Section’. It has been carefully
designed to make it the preferred choice for Process and Laboratory stand alone
equipment. It is interactive, easy to use, compliant with cGMP & GAMP 5. and suitable for all mixes of
equipment with and without software.
The document that sets the standard, and specifies your computer requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful validation to be completed. This document was designed to be used as a live document up until the DQ and is compliant with cGMP and GAMP 5.