Justification for Not Having a Validation Plan for a Critical Process

medwise

Involved In Discussions
#1
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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Ronen E

Problem Solver
Staff member
Moderator
#2
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.
 

medwise

Involved In Discussions
#3
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?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
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.
 

lawcch

Involved In Discussions
#5
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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