Dear team,
A change has been made in the method (complete method)of a product, and the existing method will not be used in the future, now shall we take only change control by revising the document with same document No. or is there any other procedure for new methodology.
You should raise Change request form as per the in-house SOP. Ensure that the new analytical method is validated and approved before Change request is approved by QA and before the new method is implemented for routine use.
Please provide a new document number for the new method to maintain the traceability of old and new methods.
It is advisable to analyze the samples from first 2-3 batches by both methods to ensure that the new method is equivalent or better than the old method. If this aspect has already been addressed in the method validation then you should not run the samples by old method.
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