|
RE: RE: RE: Old equipment qualification Contribution from Dr Niranjan Singh written on 7/24/2008 at 08:34
Original contribution: RE: RE: Old equipment qualification written by Marina Oskomic on 7/17/2008 at 16:43) The requirement for any equipment (old or new) is "suitable for intended purpose and meeting operational requirement / criteria"
In short demonstrating and establishing suitability is the requirement.
How to initiate the activities for old equipment-
Divide all equipment / facility in to following group
- Process Equipment (eg Reactor, Dryer, milling machine etc.)
- Analytical Equipment (HPLC, GC, UV, IR, LAF (if under use) etc)
- HVAC
- Water system
- Utilities
So to start
- The first step is – Creating multidiscipline team having members from QA, Manufacturing, Engineering, projects etc. department and define approach and methodology under SOP and specific activity or equipment-wise protocols.
- Second - identifying GAP between available Vs not available in terms of documents, information, technical details, history cards /data etc for each activity and equipment.
- If desired information are not available or incomplete - addressing, creating (Scientific or from manufacturer literature) rationalizing by providing supporting information to prove that "no effect on intended purpose". (Historical operational actual data of manufacturing can also be used in support)
- Each identified GAP should be addressed to prove “no impact on intended purpose”.
After creating the above, (according to my point of view)
- For process equipment - Only PQ for the actual application should be demonstrated (if dedicated facility)
- If facility is multipurpose and multi-product, dummy material should be used, which should covering entire operational range and worst case situation)
- Analytical - Complete calibration and PQ should be demonstrated
- HVAC - All components details, calibrations wherever measuring and monitoring is involved and finally PQ should be demonstrated. Seasonal variation should be addressed
- Water system - same as HVAC
- Finally report of each equipment to confirm the suitability as conclusion and recommendation for intended use.
Answers to this contribution:
Answering this Contribution:
|
|
