A
ATrenz
Hi folks. I work for an organization that is planning to move several injection molding machines to a different location within the facility.
The guidance documents that I have been able to find regarding process validation, (GHTF Process Validation Guidance is the most comprehensive that I have found) does not clearly define the reval requirements.
It is pretty well left for interpretation of what is required. We have some folks that say just ensure that the installation utilities are the same, basically an IQ. We have others that say, just get it there, and make sure that it still functions per the manufacturer's specifications (a different portion of IQ). We have others that say skip that, and perform an enhanced sampling > 30 pieces to serve as a mini PQ during the first run. Finally, we have some that say "all of the above". The only thing that no one has mentioned is testing the process control limits as you would during OQ.
The guidance that I am referring to reads:
6.4 Examples of reasons for revalidation
Revalidation may be necessary under such conditions as:
· change(s) in the actual process that may affect quality or its validation status
· negative trend(s) in quality indicators
· change(s) in the product design which affects the process
· transfer of processes from one facility to another
· change of the application of the process
The need for revalidation should be evaluated and documented. This evaluation should include
historical results from quality indicators, product changes, process changes, changes in external
requirements (regulations or standards) and other such circumstances.
Revalidation may not be as extensive as the initial validation if the situation does not require that all
aspects of the original validation be repeated. If a new piece of equipment is purchased for a
validated process, obviously the IQ portion of the validation needs to be repeated. However, most of
the OQ aspects are already established."
So, what is the general consensus? I can see an auditor reading the above in any of the fashions that my colleagues have interpreted the guidance. Again, it is a guidance doc, not a requirement.
The FDA guidelines from 1987:
There should be a quality assurance system in place which requires revalidation whenever there are changes in packaging, formulation, equipment, or processes which could impact on product effectiveness or product characteristics, and whenever there are changes in product characteristics. Furthermore, when a change is made in raw material supplier, the manufacturer should consider subtle, potentially adverse differences in the raw material characteristics. A determination of adverse differences in raw material indicates a need to revalidate the process.
One way of detecting the kind of changes that should initiate revalidation is the use of tests and methods of analysis which are capable of measuring characteristics which may vary. Such tests and methods usually yield specific results which go beyond the mere pass/fail basis, thereby detecting variations within product and process specifications and allowing determination of whether a process is slipping out of control.
The quality assurance procedures should establish the circumstances under which revalidation is required. These may be based upon equipment, process, and product performance observed during the initial validation challenge studies. It is desirable to designate individuals who have the responsibility to review product, process, equipment and personnel changes to determine if and when evalidation is warranted.
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The extent of revalidation will depend upon the nature of the changes and how they impact upon different aspects of production that had previously been validated. It may not be necessary to revalidate a process from scratch merely because a given circumstance has changed. However, it is important to carefully assess the nature of the change to determine potential ripple effects and what needs to be considered as part of revalidation.
Soooooo, any thoughts on what is required for us to perform? It is all up to interpretation, and the auditor's mood in my eyes.
Thanks so much in advance!
Adam
The guidance documents that I have been able to find regarding process validation, (GHTF Process Validation Guidance is the most comprehensive that I have found) does not clearly define the reval requirements.
It is pretty well left for interpretation of what is required. We have some folks that say just ensure that the installation utilities are the same, basically an IQ. We have others that say, just get it there, and make sure that it still functions per the manufacturer's specifications (a different portion of IQ). We have others that say skip that, and perform an enhanced sampling > 30 pieces to serve as a mini PQ during the first run. Finally, we have some that say "all of the above". The only thing that no one has mentioned is testing the process control limits as you would during OQ.
The guidance that I am referring to reads:
6.4 Examples of reasons for revalidation
Revalidation may be necessary under such conditions as:
· change(s) in the actual process that may affect quality or its validation status
· negative trend(s) in quality indicators
· change(s) in the product design which affects the process
· transfer of processes from one facility to another
· change of the application of the process
The need for revalidation should be evaluated and documented. This evaluation should include
historical results from quality indicators, product changes, process changes, changes in external
requirements (regulations or standards) and other such circumstances.
Revalidation may not be as extensive as the initial validation if the situation does not require that all
aspects of the original validation be repeated. If a new piece of equipment is purchased for a
validated process, obviously the IQ portion of the validation needs to be repeated. However, most of
the OQ aspects are already established."
So, what is the general consensus? I can see an auditor reading the above in any of the fashions that my colleagues have interpreted the guidance. Again, it is a guidance doc, not a requirement.
The FDA guidelines from 1987:
There should be a quality assurance system in place which requires revalidation whenever there are changes in packaging, formulation, equipment, or processes which could impact on product effectiveness or product characteristics, and whenever there are changes in product characteristics. Furthermore, when a change is made in raw material supplier, the manufacturer should consider subtle, potentially adverse differences in the raw material characteristics. A determination of adverse differences in raw material indicates a need to revalidate the process.
One way of detecting the kind of changes that should initiate revalidation is the use of tests and methods of analysis which are capable of measuring characteristics which may vary. Such tests and methods usually yield specific results which go beyond the mere pass/fail basis, thereby detecting variations within product and process specifications and allowing determination of whether a process is slipping out of control.
The quality assurance procedures should establish the circumstances under which revalidation is required. These may be based upon equipment, process, and product performance observed during the initial validation challenge studies. It is desirable to designate individuals who have the responsibility to review product, process, equipment and personnel changes to determine if and when evalidation is warranted.
*************************Original Page 13********************
The extent of revalidation will depend upon the nature of the changes and how they impact upon different aspects of production that had previously been validated. It may not be necessary to revalidate a process from scratch merely because a given circumstance has changed. However, it is important to carefully assess the nature of the change to determine potential ripple effects and what needs to be considered as part of revalidation.
Soooooo, any thoughts on what is required for us to perform? It is all up to interpretation, and the auditor's mood in my eyes.
Thanks so much in advance!
Adam