AN OVERVIEW OF PHARMACEUTICAL PROCESS VALIDATION AND PROCESS CONTROL VARIABLES OF TABLETS MANUFACTURING PROCESSES IN INDUSTRYAbstract
Validation is an integral part of quality assurance; the product quality is derived from careful attention to a number of factors including selection of quality parts and materials, adequate product and manufacturing process design, control of the process variables, in-process and end-product testing. Recently validation has become one of the pharmaceutical industry’s most recognized and discussed subjects. It is a critical success factor in product approval and ongoing commercialization, facilities and processes involved in pharmaceutical manufacturing process impact significantly on the quality of the products. Process controls are mandatory in good manufacturing practice (GMP). The purpose is to monitor the on-line and off-line performance of the manufacturing process, and hence, validate it.
Mahesh B. Wazade*, Sheelpriya R. Walde and Abhay M. Ittadwar
Department of Quality Assurance, Gurunanak College of Pharmacy, Nagpur-440 026, Maharashtra, India
28 May, 2012
12 June, 2012
17 August, 2012
01 September, 2012