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Justification for Not Having a Validation Plan for a Critical Process
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Justification for Not Having a Validation Plan for a Critical Process
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critical process attributes and parameters, validation plan
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  Post Number #1  
Old 25th March 2015, 06:07 PM
medwise

 
 
Total Posts: 102
Please Help! Justification for Not Having a Validation Plan for a Critical Process

Dear Experts,

We are a manufacturer of a class III medical device. There are several stages to manufacturing which includes chemical synthesis, lyophilization, packaging, gas chromatography, gamma radiation to name a few.

We have validation protocols and validation reports for all the above mentioned processes. However, do not have validation plans for chemical synthesis, lyophilization and packaging. Lyophiliser for example is qualified and process validation is covered as part of the entire process validation of the device we manufacture. For gas chromatography, we do 100% inspection on the outcome therefore we have got away without having a specific validation plan for this process.

My question is how can we justify to our NB that our critical process such as lyophilization and chemical synthesis is validated as part of the product process validation but does not have a validation plan.

Thanks

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  Post Number #2  
Old 25th March 2015, 06:43 PM
Ronen E

 
 
Total Posts: 3,736
Re: Justification for Not Having a Validation Plan for a Critical Process

Does "the entire process validation of the device you manufacture" have a plan? If so, it should be mentioning and covering every one of its sub-processes, either directly or by reference. If it does, your problem is solved.
Thanks to Ronen E for your informative Post and/or Attachment!
  Post Number #3  
Old 25th March 2015, 08:26 PM
medwise

 
 
Total Posts: 102
Re: Justification for Not Having a Validation Plan for a Critical Process

For the entire process validation of the device we only have validation protocol and process validation reports unfortunately. Validation Protocol however covers responsibilities, traceability, brief description of the process, validation strategy, test and acceptance criteria, deviations. Is this sufficient to justify that protocol acts as validation plan?
  Post Number #4  
Old 25th March 2015, 08:51 PM
Ronen E

 
 
Total Posts: 3,736
Re: Justification for Not Having a Validation Plan for a Critical Process

Quote:
In Reply to Parent Post by medwise View Post

For the entire process validation of the device we only have validation protocol and process validation reports unfortunately. Validation Protocol however covers responsibilities, traceability, brief description of the process, validation strategy, test and acceptance criteria, deviations. Is this sufficient to justify that protocol acts as validation plan?
Sounds good to me. I'm not sure how you perceive the difference between a protocol and a plan. What you describe as the protocol's contents is roughly what I'd include in the plan.
  Post Number #5  
Old 25th March 2015, 09:45 PM
lawcch

 
 
Total Posts: 19
Re: Justification for Not Having a Validation Plan for a Critical Process

in any critical process or work, there are some form of validation of processes or critical control point (CCP) as in the CCP Plan in HACCP Plan in Food safety management system, ISO 22000.

Therefore, there should be NO justification to exclude any critical processes with validation of processes if the standard or product spec. requires them.
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