Congratulations Edel Poynton. To receive this Certificate of Award, Edel had to populate a 130-page plus IQ OQ PQ protocol to qualify a Clean-in-Place System in a pharmaceutical manufacturing plant. The protocol detailed the following elements: - Product characteristics – showing what your system is looking to achieve/produce - Production equipment – detailing the equipment necessary - Test scripts and methods – telling you the steps involved in conducting a test - Test parameters and acceptance criteria – defining acceptable test results - Test checksheets – documenting and recording the test results - Final approval – documenting that the validation process has been successfully carried out. And to complete this assignment, Edel had to learn the following: - How to prioritise which parts of the equipment system are critical to qualify and which parts are not etc, using component impact assessments and risk management tools. - How to read/interpret the engineering documentation such as P&IDs, Piping Isometrics and Electrical Loop Drawings used to define the equipment system. - How the intent of a process (like maintaining the product at the required temperature) is linked to the equipment that will be used to do this. - The tests along with the functional test scripts necessary to confirm that the installed equipment is fit-for-purpose, i.e. that it will do what it states that it will do based on the User Requirement Specifications). - How to use a traceability matrix tool to ensure that all requirements defined within the User Requirement Specifications (URS) are tested in the protocol. - How to qualify equipment, instruments and piping systems, and automation controls. Well done again on your hard work!
I’m delighted to receive my Certificate of Award in ‘Commissioning & Qualification of Equipment Systems’ thanks to all in great guidance throughout the course GetReskilled Donagh Fitzgerald
