GAMP (Good Automated Manufacturing Practice)
What does the abbreviation GAMP mean?
The abbreviation GAMP stands for "Good Automated Manufacturing Practice". Specifically, it is a guideline for the validation of computer-controlled systems that are used, for example, in pharmaceutical production, medical device manufacturing, the food and beverage industry and in clinical diagnostics.
The GAMP guidelines and the GAMP Good Practice Guides are published by the International Society for Pharmaceutical Engineering (ISPE). These are regularly updated and apply to the area of pharmaceutical water, which is used for the manufacture of medicinal products.
What role does GAMP play in pharmaceutical water treatment?
GAMP plays an important role in pharmaceutical water treatment and sets the framework for the development, operation and maintenance of automated water treatment systems. GAMP contains a series of guidelines that apply specifically to the development, validation, operation and maintenance of computer-controlled systems for production in the pharmaceutical and biotechnology industries.
The principles include risk-based approaches, a life cycle approach, system validation, compliance with regulatory requirements, appropriate documentation and qualification of suppliers and service providers. The aim is to establish proven standards and best practice for the development and operation of automated systems. In doing so, the integrity of the manufactured products should be guaranteed and compliance with the applicable regulations ensured.
What are the latest developments?
The ongoing development of IT landscapes in recent years makes it necessary to regularly revise and expand the guidelines. The new version of the GAMP Guide, published in July 2022, focuses on reflecting the challenges and changes in the IT landscape. The update includes a comprehensive revision of the content, including new and expanded appendices that address new technological areas such as artificial intelligence (AI) and blockchain.
The document also refers to the use of agile development methods and the integration of cloud services. This allows for greater flexibility and adaptability in the validation of computerised systems. It also includes important changes to risk assessment and quality management to ensure the continuous quality and safety of products.