Csv Stories

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"It's just like the multinational pharmaceutical businesses deliberately designing toothpaste tubes so that you cannot squeeze out the last bit of toothpaste," I blurted. There was stunned silence while my colleagues seated on a circle of chairs in the middle of a low-ceiling conference room stared at me blankly. Was this young man mad? Perhaps I was. I cannot recall to which discussion topic my poorly chosen conspiracy theory analogy was intended to refer, but I clearly remember the reaction. I was present because a letter from Ric, our manager, had instructed me to attend. I had no comprehension what this meeting was intended to achieve. By the time I opened my mouth, the gathering had seemed somewhat pointless.

Introduction: In the highly regulated life sciences industry, computerized systems play a critical role in ensuring the safety, efficacy, and quality of pharmaceutical products. To maintain compliance with regulatory requirements, organizations must adhere to industry best practices for computerized systems validation. The GAMP 5 (Good Automated Manufacturing Practice) guidelines provide a comprehensive framework for validating computerized systems, ensuring their reliability and integrity. This blog will explore the key principles and processes outlined in GAMP 5, highlighting the importance of compliance and quality in the life sciences sector. Understanding GAMP 5 : GAMP 5 is a globally recognized set of guidelines developed by the International Society for Pharmaceutical Engineering (ISPE). It provides a risk-based approach to computerized systems validation, focusing on the entire lifecycle of a system, from concept to retirement. The guidelines aim to ensure that computerized systems are fit for their intended use, meet regulatory requirements, and minimize the risk of errors or failures that could impact patient safety or product quality.

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