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?”
EudraLex
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.
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.