Method Validation

Hello Everyone,
Good day to you.
Please help me regarding below issue.

“Is there any rule of skipping validation of mid strength batch while performed in upper & lower strength. for example, Atorvastatin calcium 10 mg tablet, 20 mg tablet, 40 mg tablet are present. Method validation of 10 mg & 40 mg were performed , 20 mg was not done. is it complied by any regulation/rules?”

Any reference will be helpful.

waiting for your valuable feedback.

No need to do validation for 20 mg. You can cover by 10mg and 20 mg. Your have to do a assessment.

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Thank you Sir for your valuable feedback.

Could you please help me providing any reference please?

Volume 4
EU Guidelines for
Good Manufacturing Practice for
Medicinal Products for Human and Veterinary Use
Annex 15: Qualification and Validation (12 No. Point). Bracketing Approach.

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Hi Sharmin,

You can use take lower strength (i.e 10 mg) of tablet to performed validation activity and other strength use to performed only two validation parameter i.e Method Precision and Specificity.
Lower strength is a worse condition so as per my opinion validation perform on lower level formulation.

Thank you very much for your feedback

You are right. Thank you very much for your effective feedback.