Re validation depends up on the following factors…
- Change in the methodology
- Change in the process
- Change in the critical parameters
If there is no change observed in the process/system/equipment, you can consider the product quality review data as retrospective validation. There is no specific guideline insisting the duration for revalidation.
Thanks and regards
In order to answer your query, all should understand the concept of re-qualification / Re-validation is why enforced by regulatory agencies ? Why it is required ? & what at all is expected to do in that document ?
In actual, based on assessment of criticallity one can stretch the re-qualification / re-validation periode from the time range from 3 Month to 7 Years (What I had seen…in my exp.), while assessing the re-qualification/ re-validation time period one should take foollowing points under consideration
- Criticallity of System
- Degree to failure
- Maintenace schedule
- Operation performed
- If not maintained, Impact ?
- Evaluation of eq. History in terms of calibration, Maintenance, Operation, deviation, Failure, cleaning etc.
- tests i am planning to be performed in re-qualification/ re-validation
- What is the frequecy stated in the guidance for those tests ?
If you have a sufficient data in place…you can review the old data & compile the details at one place in term of summary / review report… (You may refer the FDA process Validation guidance for further clarity on the requirements expected by the agency).
Happy Reading !
Yes, you are right now a days Continued process verification is the term Regulatory agencies looking for. In actual cleaning & process validation are goes hand in hand. The basic cGMP concept states i.e. Process should be run in qualified & cleaned equipment. Cleaning process may be of different types. In case of new equipment you have to go through new equipment cleaning verification cycle…where you are not verifying the previous products but ofcourse ensuring Visual cleanliness & remanants of cleaning process (If any)… After completion of process need not to mention for multiproduct / campaign serving facility should undergo cleaning validation (As applicable).
Happy Reading !