Pharmaceutical Process Validation: A Review

Abstract

Validation is the art of designing and practicing the designed steps alongside with the documentation. Process validation emphasize on process designelements and maintaining process control during commercialization andcommunicate that process validation is an ongoing program and alignprocess validation activities with product lifecycle. Process validation alsoemphasizes the role of objective measures and statistical tools & analysesand emphasizes knowledge, detection, and control of variability and givesassurance on consistent of quality/productivity throughout life cycle of product. According to GMP, validation studies are essential part of GMP these are required to be done as per predefined protocols. The process validation is establishing documented evidence which provides high degree on assurance that a specific process consistenly produced a product meeting its predetermined specifications and quality characteristic. The validation study provide the accuracy, sensitivity, specificity and reproducibility of the test methods employed by the firms, shall be established and documented. Thus the validation is an essential part of the quality assurance. Lending importance to validation is increasingly profound in recent years.

A Concept of Process Validation in Pharmaceutical Industries

“…Stage 3: The third stage of this process is called as the validation upkeep Stage. This stage requires different parameters like the visit investigation of all fundamentals related records, also to ensure the review the data of validation, to guarantee that there have been no mismatch, alteration, deviations, changes in the parameter and acclimations to the creation process and that all SOPs, including methods of change control, which have been followed in the process and all parts or bundles passed on will followed to their typical nuances, and it will ensure the safety and efficacy towards the complete ongoing processes and enhance the quality of the product [6].…”

“…The objective of a quality structure is to constantly pass on things that are fit for their ordinary use. The endorsement is the place it incorporates people from various controls of the plant [6]. In the various human activities scaled as well as downscale, the animals in the earth address, a concealed anyway dangerous peril factor.…”

Basic Concept of Process Validation in Solid Dosage Form (Tablet): A Review

“…It is a predetermined scientific approach having a validation protocol which include steps of process development, sampling plan, batch record, specifications for API/ excipient/packaging material, pilot runs, transfer of technology from scale-up to commercialized batch, list of all processes to be performed with environmental controls like temperature and humidity. 8…”

Validation – a brief introduction

“…literature, no CGMPs (Current Good Manufacturing Practices) law has spoken about the validation process (Chapman K.G, 1991quoted in Keyur et al, 2014. The validation concept has expanded over the past few years in a wide range of activities, from the methods of analysis used to control the quality of medical substances and drugs to computerized systems, the validation process has become an important and integral part of CGMPs (Kaur et al, 2013).…”