Process validation and stability study

GOOD VALIDATION PRACTICE (cGVP) PROCESS VALIDATION
1

Please help me some question about process validation.

  1. What is Optimization batch?
  2. Optimization validation batch possible to convert prospective validation batch.
  3. In case we are convert to Prospective validation batch what are document require? Please Explain . If any guidelines please provide

Stability Study:

  1. What are the parameter required for stability testing? Chemical test: Example Assay, Dissolution, Physical parameter required for End of shelf life product?

regards//Siva, Validation

2

Accordign to ICH Q1A, section 2.2.5…
Stability studies should include testing of those attributes (quality parameters) of the drug product that are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy. The testing should cover, as appropriate, the physical, chemical, biological, and microbiological attributes, preservative content (e.g., antioxidant, antimicrobial preservative), and functionality tests (e.g., for a dose delivery system). A single primary stability batch of the drug product should be tested for antimicrobial preservative effectiveness (in addition to preservative content) at the proposed shelf life for verification purposes.