Abstract

VALIDATION: A REVIEW

Dr. S. J. Wadher*, Sachin Tayde and Dr. S. G. Gattani

Abstract

The article provide outline of validation includes definition, types of validation, process validation, cleaning validation and terms like ongoing process verification during lifecycle, verification of transportation, validation of packaging, qualification of utilities. Validation need to provide assurance of the process, facility, equipment and system which produce reproducible result as compared with its predetermined specification and quality attributes. It differentiates between validation and qualification. The concept applicable for human drugs, veterinary drugs, biological and biotechnology products, active pharmaceutical ingredient (API) manufacturers. During development of process validation the modern concept of pharmaceutical development(ICH Q8), quality risk management(ICH Q9), pharmaceutical quality system(ICH Q10) apply during process design and development stages in process validation.

Keywords: Quality, Validation, Process Validation, Pharmaceutical.