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
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