Parajuli et al Journal of Drug Delivery & Therapeutics. 2015; 5(6):1-7 1 © 2011-15, JDDT. All Rights Reserved ISSN: 2250-1177 CODEN (USA): JDDTAO Available online on 15.11.2015 at http://jddtonline.info Journal of Drug Delivery and Therapeutics Open access to Pharmaceutical and Medical research © 2015, publisher and licensee JDDT, This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited REVIEW ARTICLE A REVIEW ON PHARMACEUTICAL PROCESS VALIDATION OF SOLID DOSAGE FORM [TABLETS] Parajuli Rishi Ram 1 *, Shrestha Saroj 1 , Lamichane Shreekrishna 1 ,Pokhrel Priyanka 2 . 1 Production Pharmacist, TIME Pharmaceuticals Pvt. Ltd, Nepal 2 Dossier Pharmacist, TIME Pharmaceuticals Pvt. Ltd, Nepal *Corresponding Author’s Email: Positive.rishiram@gmail.com Received 02 July 2015; Review Completed 29 Aug 2015; Accepted 29 Aug 2015, Available online 15 Nov 2015 1. INTRODUCTION: The concept of validation was first proposed by two Food and Drug Administration officers, Ted Byers and Bud Loftus, in the mid 1970’s in order to improve the quality of pharmaceuticals. Pharmaceutical Process Validation is the most important and recognized parameters of CGMPs. 1 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. The process validation is standardization of the validation documents that must be submitted with the submission file for marketing authorization. 2 The process validation is intended to assist manufacturers in understanding quality management system(QMS) requirements concerning process validation and has general applicability to manufacturing process. 3 Some Defination of Validation: According to FDA, 4 Assurance of product quality is derived from careful and systemic attention to a number of importance factors, including: selection of quality process through in-process and end-product testing. According to US FDA in 1978, 5 “A validation manufacturing process is one which has been proved to do what it purpose or is represented to do. The proof of validation is obtained through the collection and evaluation of data, preferably, beginning from the process development phase and continuing the production phase. Validation necessarily includes process qualification (the qualification of materials, equipment, system, building, personnel), but it also includes the control on the entire process for repeated batches or runs”. European Commission - 1991 - Validation - “Act of proving, in accordance of GMPs that Any” process actually leads to expected results. European Commission - 2000 - Validation - “Documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes”. 6 WHO guidelines define validation as Validation is documented act of proving that any procedure, process, equipment, material, activity or system actually leads to the expected results. Validation act of proving, in accordance of GMPs that any process actually leads to expected results. Documented evidence that the process, operated with in established parameters, can perform effectively reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes. 2. Types of Validation 7 2.1 Analytical Validation Analytical validation is the evaluation of product quality attributes through testing, to demonstrate reliability is being maintained throughout the product ABSTRACT: The article gives an introduction and general overview on process validation of pharmaceutical tablet manufacturing process. Process Validation is one of the important steps in achieving and maintaining the quality of final product. Process validation emphasizes the role of statistical tools and analyses, knowledge, detection, and control of variability and thus gives assurance on consistency of quality product. The validation study provides the accuracy, sensitivity, specificity and reproducibility of the established and documented test methods employed by the manufacturer. Thus, validation is an essential part of the quality assurance. This review examines the need for pharmaceutical validation, the various approaches, process and steps to be monitored during tablet manufacturing process. Key words: Process Validation, Types, Validation Stages, Guidelines and Process.