gamp 5 guidelines for computer system validation pdf

Sangeetha NKD, Bala krishna P, Development and validation of a UPLC method for the determination of duloxetine hydrochloride residues on pharmaceutical manufacturing equipment surfaces, Pharmaceutical Methods, 2011 2 (3):161–166.ģ. Keywords: Computer system validation, Validation, Qualification, GAMPġ.Ěgalloco, J, Carleton FJ, Validation of Pharmaceutical Process, 3rd Edition, USA, New York: Informa Healthcare, 2008.Ģ. This study aims to identify needs of computer system validation of instrument/equipment practiced in the perspective of pharmaceutical industry. Computer system validation checks the effectiveness and the efficiency with which the system is meeting the purpose for which it was designed. It’s essential to maintain quality standards in pharma since non-conformance can have far-reaching consequences. The same principles are applied in computer system validation to a computer system or an information technology system. A validation assessment program is a necessity in the pharma industry to ensure adherence to pharmaceutical cGMP guidelines, and to help companies maintain consistent quality. Currently, this practice forms the core of the regulations that are strictly followed by pharmaceutical companies worldwide. One of the major GMP requirements is that all of the critical manufacturing equipment, utilities, and facilities in the pharmaceutical industries must be properly qualified and validated prior to production. GMP ensures that products are consistently produced and controlled according to the quality standards appropriate to the intended use and as required by the marketing authorization.

In this regard, the Food and Drug Administration introduced good manufacturing practice (GMP) to maintain and improve the quality of pharmaceutical products. It is also important as it relates to life-saving products such as pharmaceuticals. Quality is an imperative for customers whenever they consider a product or service.

If a system meets these requirements, it can be assumed that it is consistently performing in the way it was intended. Computer Systems Validation (CSV) is a process used to ensure (and document) that a computer based systems will produce information or data that meet a set of defined requirements.

Gamp 5 guidelines for computer system validation pdf