B. Venkateswara Reddy*, K. Navaneetha, B. Rashmitha, P. Sandeep
Department of Pharmaceutics, St.Paul’s College of Pharmacy, Turakayamjal(V), Hayath Nagar(M), Ranga Reddy Dist-501510, A.P, India.
Pharmaceutical Process Validation is the most important and recognized parameters of CGMPs. The requirement of process validation appears of the quality system (QS) regulation. The goal of a quality system is to consistently produce products that are fit for their intended use. Process validation is a key element in assuring that these principles and goal are met and it is an important component in the design, prototyping and manufacturing process and assures that a process will consistently produce product, meeting its predetermined quality characteristics and attributes. The present article focuses mainly on the process validation aspects of solid and liquid dosage forms.
Keywords: CGMPs, Process validation, Quality system regulation, manufacturing process.