Hi Jonathan, Congratulations and well done. In order to receive this Certificate of Award, Jonathan had to populate a 120-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.
To complete this assignment, Jonathan 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' from GetReskilled
Geraldine Creaner Donagh Fitzgerald
Virtual CFO | Financial Planner | Transaction Advisory| Leadership Coach for Businesses| Scaling and Selling Closely Held Businesses
3wNo-one could deserve it more, American Commercial Barge Line (ACBL)! Thank you for all you do!