Open AccessValidation – In pharmaceutical industry: Equipment validation: A brief review
Author(s) -
Diksha Jindal,
Hardeep Kaur,
Rajesh Kumari Patil,
Hanumanthrao Chadershekar Patil
Publication year - 2020
Language(s) - English
DOI - 10.25259/aujmsr_15_2020
Subject(s) - process validation , documentation , data validation , process (computing) , pharmaceutical industry , computer science , instrumentation (computer programming) , product (mathematics) , model validation , systems engineering , risk analysis (engineering) , verification and validation , manufacturing engineering , engineering , operations management , data science , business , medicine , database , programming language , operating system , geometry , mathematics , pharmacology
Validation is the procedure which authorizing documentary evidences that prove, the following process/ method or activity will consistently produce the product which leads to the expected result (predetermined requirements). The validation program in pharmaceutical industries involves various components which are related to processing, cleaning, facilities, equipment, or instrumentation. In this review article, we will go through a brief discussion about one of the most preferred method of validation which is equipment validation. In equipment validation, we will discuss about its types in detail, what kind of documentation is required and applications/importance of validation in pharmaceutical industry. Nowadays, equipment validation becomes the regulatory requirement for pharmaceutical companies to precede the validation of new equipment’s/instruments. Meanwhile, the process of validation requires detailed knowledge of that instrument which is going to validated; therefore, the validation is usually performed by the company which supply that equipment.