So your boss asks you to formulate a template to validate all of the equipment types in your organisation, where do you start? Seems like a very daunting task, how can you formulate a template that will include all the essential elements of equipment validation.
Let’s say for example you are working in the Medical Device field what regulations should you base the requirements on?
The main requirements that should be focussed on include:
- (FDA) Design Control Guidance for Medical Device Manufacturers (March 11, 1997)
- GHTF/SG3/N99-10:2004 (Edition 2) Process Validation Guidance for Medical Device Manufacturers endorsed by ICH, January, 2004
- FDA Compliance Guidance-General Principles of Process Validation. US Food and Drug Administration Center for Drugs and Biologics and Devices and Radiological Health, May 1987
So lets break down what needs to be qualified in order to bring the equipment into a state of compliance. Remember this is just a starting point, for a full list please refer to the requirements above.
a) All relevant equipment drawings are available and verified:
- Mechanical drawings
- Electrical schematics
- Process & Instrument drawings
- Pressure/Vacuum Rating ASME Code Stamp)
b) User manual
c) Spare part list
d) Software Documentation (ex. Ladder Logic) E-copy and hard copy (if applicable)
2. Equipment Design/Component Verification
a) All major Equipment/Components design verified via Design Qualification or equivalent (ex. Approved Engineering Specifications and Design Review and/or IQ verification).
b) Certification of materials of construction used, equipment finish.
c) Main components within preventive maintenance program.
d) Special cleaning and intervals established, if applicable.
3. Verification of Critical Instrument Calibration
a) Primary Instruments listed in the calibration program (i.e. control and process monitoring instruments, not backup indicators).
b) Instrument Resolution and Accuracy are identified and adequate for process control range required.
c) Traceable Standards Used.
4. Utilities Supply
a) Electricity (With all connections verified)
b) Clean steam boiler (With all connections verified)
c) Compressed air (With all connections verified)
d) Nitrogen (With all connections verified)
5. Environmental requirements
d) Noise level
e) Electrostatic discharge isolation
6. Safety Code
a) Electrical wiring/disconnects
b) OSHA or AFS applicable standards for noise level
7. SOPs Availability
b) Software (PLC) Configuration Control and Disaster Recovery
8. Validation Instrumentation
a) Validation instruments used in IQ are listed and within calibration due date.
This is not an exhaustive list but it will help anyone new to equipment validation to get a taste of what is involved when you are
developing your IQ, OQ, PQ, FAT or SAT documentation.
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