Qualification in Pharma
Hello everyone! I am working in Pharma industry for 5 years as Qualification Specialist, Manufacturing and Automation Specialist. I wanted to share concepts and controls that has been performed on the Pharma Industry with you.
Firstly we must start with Qualification in Pharma!
Installation Qualification (IQ)
Installation Qualification performed for the verifying instrument and unit of equipment being qualified and configured according to the specifications that is specified in the manufacturer’s handbook. Although the overall Equipment Installation were controlled on IQ, the placement, P&ID’s etc. needs to be controlled.
You can also verify the placement and cables of the equipment. Also you need to have a overall plan for the validation, qualification as a whole. You must have a validation plan (VP) in the first place.
Of course, when you made or create a change on the equipment that is effecting the equipment installation, you need to re-validate the Installation Qualification by requesting a correct change control.
What can be needed for IQ?
- Location of install and necessary floor space
- Documentation of any and all computer-controlled instrumentation
- Gathering all manuals and certifications
- Properly unpacking and cross-checking instruments
- Examining instruments and components for damage
- Ensuring correct power supply
- Installing ancillary instruments
- Documenting firmware versions and serial numbers
- Environmental and operating conditions
- Checking software system installation and accessibility
- Recording calibration and validation dates of tools used for IQ
- Verifying connections and communication with peripheral units
IQ Documentation
“Write what you have done, do what you have write”.
That is the motto of FDA regulations in the first place. In the case of qualification and any changes on the pharmaceutical equipment, you need to document these. In the case of IQ, there must be IQ protocol, IQ checklist (optional) and IQ report. IQ protocol have the steps that needs to be taken for testing. IQ report summarises and have all the results. Even though I have never used IQ checklist, it is composed of physical installation checks, electrical connections, calibration, software installation, and environmental conditions.
What should you be careful?
- You need to be careful to bring P&ID and placements during your IQ. They will be the guides during execution.
- P&ID`s and Layout Plan sometimes do not reflect the real world. This situation can led to difficulties and errors during execution and future expansions. You need to create a deviation and start a change order for the relevant documents.
Operational Qualification (OQ)
Operational Qualification (OQ) must be performed after Installation Qualification has been performed.
There is a document that needs to be approved before qualification of the equipment. User Requirement Specification, URS for short. This implies and states the requirements of the process and and what needs to be done by equipment. Although some requirements are tested in Installation Qualification most of the requirements are tested on OQ.
What is tested in Operational Qualification?
In OQ occasionally tested:
- Temperature control and variations
- Servo motors and air flaps
- Temperature protection systems
- Card readers and access systems
- Pressure and vacuum controllers
- Temperature distribution
- Display units and signalling LEDs
- CO2 controls
- Humidity-measuring and control
- Fan and fan-speed controllers
I was dreaming about servo motors after long OQ’s.
Operational Qualification Documentation
There needs to be OQ protocol that approved by Line of Business and Quality in the first place. Without it, whether it is tested or not, it will not be approved or manufacturing cannot be done without a proper documentation. Again, “Write what you have done, do what you have write”.
After you have performed and close all of the deviations, you need to write a Operational Qualification Summary Report. This will going to summarise what has been tested and deviations occurred during execution. Because of this, of course tester must be competent and write everything that has been performed.
What should you be careful?
- You need to test whole operating range. If there an indication that machine can operate in 100–800 m/hr, then you should test the whole range before you start manufacturing.
- You need to test the failure modes and errors of the equipment. You need to make sure that equipment will behave or give the related error on the exact situation happened. This is very important part of the OQ.
- If the equipment operates with PAS-X you need to test that communication, if it is interfacing with SAP, you need to test the connectivity.
- Environmental variability, if the equipment can operate under different conditions, you must simulate that artificial conditions and you need to test the equipment under that conditions.
- Data Integrity! It is important for every test.
Performance Qualification (PQ)
Performance Qualification is the last part of the testing and after approval of the PQ, that means that you can manufacture drugs with that equipment.
But there is catch there! You need to manufacture the drug within qualified speed and time. If a equipment is performance qualified for producing 1 vial/min and 80 vial / min, you cannot manufacture drugs with 100 vial/min speed. And also you need the samples for the PQ. You need to prepare a sampling plan with adequate, mathematically reasonable samples and test them.
What should you be careful?
- If you do not have real-time monitoring of the critical data (API content, filling volume etc.) you must utilise them during testing. For example, some machines have built-in weight measurements that measure the weight. If you do not have real-time monitoring you need to have a sampling plan and test it.
- As we have said before, PQ will going to determine speed and production. You need keep in mind of future scaleability and different production needs. You need to keep in mind worst and best conditions for the manufacture.
Conclusion
You need to validate your production equipment and software if you are producing medicine. You need to have this idea back on your mind that, there is human and animal life at stake. Some companies can rush things to reach a deadline or increase production, however, you need to put your hand up and say if there is non-appropriate behaviour. This is also related to company culture. You need to have a company culture that you can say these complaints and deviations to your managers. There is a role for everybody on this.
