Analytical method validation in R&D


(Srimurugan) #1

Dear All

This is regarding Analytical method validation (AMV) and cleaning method validation (CMV) of API.

We perform AMV/CMV at R&D and provide the package to QA for production activities.

The AMV/CMV is adopted by QA following method transfer activity.

The question is,

(i) Performing AMV/CMV at R&D is correct or should it be performed at production.

(ii) By transferring AMV/CMV package from R&D, will it be subjected to regulatory audit?

(iii) I was told that, since method transfer is adopted by QA, it only will be responsible for responding any query during audit and R&D will not be included. Is it right?

(iv) What is the best practice.

Thanks
Regards
Srimurugan


(Sunil R. Budhkar) #2

The strategy adopted by your company is OK. However, please note that following g documents must be available during any Regulatory inspections.

  • AMV/ CMV protocol
  • AMV / CMV report
  • Raw data for above validations
  • Technology transfer protocol
  • Technology transfer report for above
  • Raw data for above aspects
  • Cleaning validation protocol
    Cleaning Validation execution on 3 commercial production batches
  • Cleaning Validation report on 3 batches as above
  • Raw data of Cleaning Validation as above
  • Summary on Conclusion on Cleaning Validation
  • Final SOP on Cleaning of manufa turing equipment based on Cleaning Validation exercise as above.
  • Training records of all involved employees

Generally, any Regulatory inspection is lead by QA. However, depending upon situation, R&D should be involved in answering the questions related to the Cleaning Validation they have done.
In any Regulatory inspections or audits the concerned persons who are responsible for performing the tasks should answer the questions. QA should overall support during inspection and in case of QA related aspects or any further explanation is required.


(Srimurugan) #3

Perfect & Thanks

For information, We do have all activities mentioned by you. Also other requirements like change control, investigation of deviation are also in place.

Regards
Srimurugan


(Sunil R. Budhkar) #4

Thanks. This is fine.