Variation submission

dear All,
Good day.
I find this group very useful. thank you for your full support.
please help me in following issues:

" please help me with reference (link or guideline name) of ICH or WHO or FDA Variation submission guideline to regulatory bodies. variation means changes in formulation, tablet color, shape etc".

please help me with reference .
thank you.


  • Guidance for Industry, Immediate Release Solid Oral Dosage Forms, Scale-Up and Post approval Changes. CDER, FDA.

  • WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report, WHO guidelines on variations to a prequalified product.