GMP-ENGELSMost GMP documentation has either a witnessed by or verified by column which can be filled out.  It is understood by most that this is a critical step to ensure compliance. Yet when reviewing records there is typically a high error (deviation) rate.   This is probably due to many reasons, one of which is a lack of understanding as to why we fill out GMP documents and what the difference between verified by and witnessed by is.

Typically, there is a failure to correctly fill out GMP documentation for several reasons.   I have seen training’s held at companies and discussed with leadership at several organizations and the message we are giving as an industry doesn’t seems to be translated into good practice.  Typically what people are trained on for documentation is  “Because the FDA says we have to”. If you ask for more details you typically hear about the consequences “we will get a 483”…  “I will get in trouble with my boss”… “There will be a deviation”.    I am not sure this sends the right message, or really shows people why they need to correctly fill things out.  Whenever I am given the answer “because the FDA says we have to” I challenge people to think about why the FDA wants us to do these things.  Ultimately it is usually about control of our processes (Batch records) or equipment (validation documents).  So why do we put our initial on things?   To ensure they are done.  Same as when we have a list of task or a shopping list at home and we want to be sure we don’t miss something.  We don’t cross things off “so we don’t get in trouble”.  We cross them off so we are confident we did everything on the list.  I have seen people trained on GMP documentation with the message  that this is your tool to feel confident you have done everything you needed to do today. The training focuses on the positives of good documentation instead of all the consequences of poor documentation.  In general those organizations have a much lower deviation rate for documentation error.  A side benefit is that if people understand this concept you will generally have better documents, but we will talk about that in another blog.

ballValveAnimationNow that we understand why we do fill out these records, what’s up with verified by and witnessed by.  Well verified by just means we know someone else did the step or in some cases the calculation.  If there is a critical safety step to ensure a valve is turned off, I want someone else to verify that the valve has been turned off BEFORE proceeding.  This is why this step must be done prior to performing the next step.   It is also used frequently for calculations.  The calculation has to be verified as correct before proceeding.  Witness is for when I have to watch someone do something.  It is typically for things that cannot be verified after.  I can verify that a valve is in the right orientation, but I cannot verify if an excipient has been added to a solution.  Witnessing is for steps in which I have to see it performed to ensure it was done correctly.  I have audited organizations and one example of an error  I have seen multiple times is related to calculations.  I have seen people witness someone making a calculation, but never verify that it was done correctly.   By definition I can witness you add 1+1 and get 3.  I would want this step verified.

By thinking more about what these things mean you can write better records in which staff will be motivated to do correctly because you can express the logic.  This will lead to better compliance and safer drugs for our patients.  Audit_openerThis is just one example of where our industry has become complacent with the answer “because the FDA says so” without thinking about why we do it.  Without that understanding and without sending that correct message it is no wonder there are so many deviations around this topic.

Written By: Mike Murphy, Senior Consultant

ICQ Consultants, Corp.

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