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After 40 years of pharmaceutical quality management, analytical experience and hosting many regulatory inspections, Tepnel has formulated 10 essential principles of analytical engagement to ensure compliance and data integrity.
1. Assume nothing, check do I have the correct sample / method combination? Are all the materials I need available; is the sample I have consistent with my paperwork and the lab schedule? Stop if something is not right and ask.
Assume nothing, check do I have the correct sample / method combination? Are all the materials I need available; is the sample I have consistent with my paperwork and the lab schedule? Stop if something is not right and ask.
Preparation, preparation, preparation, it’s all in the preparation. Have everything you need to hand and know where everything is, planning ahead will ensure you don’t come up against unexpected roadblocks.
My reagents / materials are fit for purpose, make sure they are the ones specified and have not expired? Be vigilant, this check can save a lot of wasted effort and be especially cautious when expiry dates are close to the date of use.
I have everything labelled, what is it? made by whom? When? for what work? and when does it expire?
Is my equipment fit for purpose? Is it within its validation / calibration or service dates, is it appropriate for the test e.g. variable pipette used within its accuracy limits, no label? Stop and check.
The Analyst is the first checker, if the results are not right, it is your responsibility to inform your supervisor. If data is not 100% correct it can never aspire to be 100% correct.
Record everything as it happens and make sure its legible. Nothing worse that returning to records months later and wondering what has been written. In certain circumstances e.g. in sterility suite, record as soon as is practicable.
Record all critical values. Weights, volumes, test observations, measurements if not recorded at the time cannot be recorded later and if missing will invalidate any testing.
Do not Anticipate, do not record results, observations etc. which have not yet happened. This is fraudulent.
Sign and date, everything needs to be attributable to the person making the record. Make sure explanatory notes are clear and don’t cram them into a corner of the page. Clarity is all.
Our cGMP pharmaceutical testing facility is located in Livingston, Scotland where we work together with our customers and partners building mutual trust through a sharing of knowledge, expertise and teamwork. Our services include:
- Lot and batch release testing
- ICH stability testing and storage
- Raw materials testing
- Pharmacopeial testing
- ICH method development and validation