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Pharmaceutical companies, if they correctly interpret and apply the GAMP 5 guidelines, can provide the required quality of products. Although GAMP 5 is not a regulation but a set of principles and procedures that aim to ensure that manufactured pharmaceutical products meet the required quality standards, most pharmaceutical companies that want to achieve automated systems that are fit for purpose have adopted these. The standard GAMP 5 practical guidelines revolve around four principles.
First, this approach helps users interpret regulatory requirements for computerized pharmaceutical product manufacturing. Second, it establishes a common language and terminology that ensures a systematic and well-defined approach to the production of pharmaceutical products while the third approach is to ensure a system life cycle approach that covers all aspects of production; From the beginning of the raw material to the finished product based on good practices.
The final policy looks at the roles and responsibilities of each player along the production line to suppliers. As this guideline provides a framework for both users and suppliers, they have to work in harmony with each other.
For users, GAMP guidelines provide principles that ensure that the automated system is fit for intended use before pharmaceutical products are produced, while suppliers are guided by GAMP to check for any avoidable errors in the system to ensure that the delivered products are safe. The pharmaceutical industry meets high-quality standards. GAMP is compliance with risk based procedures.
