Open AccessProcess Validation in Pharmaceutical Product Development: An Overview
Author(s) -
T Sriranga.,
Naveen Banakar,
Vaishakha Kori,
Chetankumar Vasanad
Publication year - 2021
Publication title -
journal of biomedical and pharmaceutical research
Language(s) - English
Resource type - Journals
eISSN - 2589-8752
pISSN - 2279-0594
DOI - 10.32553/jbpr.v10i5.883
Subject(s) - process validation , process (computing) , computer science , product (mathematics) , new product development , manufacturing engineering , quality (philosophy) , manufacturing process , process engineering , engineering , business , materials science , mathematics , philosophy , geometry , epistemology , marketing , composite material , operating system
As per GMP process validation is very important and required part in product development. Process Validation is required for ensuring and providing the documentary evidence and also required for giving the Surety that process by which the formulation is prepared is capable of consistently producing the product of required quality and purity.
A validated manufacturing process is one which has been proved to do what it purports on 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 through the production phase. Validation necessarily includes process qualification (the qualification of materials, equipment Systems, buildings, personnel), but it also includes the control on the entire process for repeated batches or runs. This article gives a general introduction and overview about process validation in pharmaceutical manufacturing process and its importance.
Keywords: GMP, Validation, validation manufacturing process.