Hi if a drug is official in a monograph and if we are following an in house method instead of the pharmacopoeial method whether the inhouse analytical method is accepted by regulatory authority of USFDA?
If they accept what sort of justification we need to provide to them?
Whether we can show only the validation of inhouse method or we need to prove that the inhouse method is more precise and accurate than the pharmacopoeial method?
Hi Ramkumar,
Often the official monograph methods are based on old technology and modern equipment and techniques are superior. This is probably why you are using an in-house method rather than the pharmacopoeial one?
FDA are likely to accept your in-house method but you will need to conduct a full method development and validation...linearity, range, accuracy, specificity, precision, robustness, ruggedness at various levels across the analytical range dependent on the type of test it is. The validation report from this work should demonstrate appropriate accuracy and precision of your in-house test and it shouldn't be necessary to set up the pharmacopoeial test in your lab to generate comparative data although this might make your report stronger if you have the capability to easily do so.
You should make mention of the pharmacopoeial test in your validation report and discuss the sort of accuracy and precision required for assuring the safety, identity, potency of the drug, then discuss how your in-house method is suitable for this purpose and why it is preferable to use your method over the pharmacopoeial one, or you could write up the test requirements in a Design Qualification report to preface your method development and method validation reports.
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