Interesting facts from the field of validation
The validation knowledge area answers questions about the validation master plan, software validation and cleaning validation. You will find information on the goals of software validation and the core elements of the GAMP® 5 guidelines.
Here you will find answers to the following questions:
What are the core elements of the GAMP® 5 Guide?
The GAMP® 5 guide "Good Automated Manufacturing Practice Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture" has, to a certain extent, become the standard for software validation over the past decades. Important core elements of the GAMP® 5 are:
- Risk-based approach to the validation of computer-based systems
- Separation of risk classes for hardware and software
- Still considered best practice, especially in the context of regulatory and certification requirements (e.g. ISO 13485:2016).
What is the goal of software validation?
Software validation is intended to prove that a particular piece of software works reliably and robustly within its intended use according to its specifications - this approach is not new. It is identical to the procedure already followed for the qualification of hardware and for which the familiar validation tools such as IQ/OQ/PQ are used.
What role does the "Sinner's circle" play in the cleaning of pharmaceutical plants?
For the cleaning of pharmaceutical plants it is of particular importance that a robust cleaning process is developed and established. The "Sinner's circle" takes into account four factors (mechanics, temperature, chemistry and time) influencing the cleaning process, the optimum coordination of which allows cleaning to be carried out economically and safely.