Dear Theleria, you asked the following questions
regarding Good Laboratory Practices (GLP) Standard Operating Procedures
1) how extensive are your SOPs? After several client audits we have
learned to write our SOP's with leaway. If you write
your SOP's describing every little second you stain or exactly how
many dips used it may cause you problems. It is important that if staining
only requires 20 seconds than that is what you state in the SOP. However,
if thre is a window such as 20 seconds to 1 minute than that is what we
state. We had one auditor that did not our staining windows written in the
SOP's. We explained that not all tissue stains the same, therefore we
needed staining window. Some descretion must be left up to the experienced
technician. In our paraffin SOP's we do not write all the steps for
deparaffinization and rehydrating to water. Most of the histology books do
not do that. The technicians performing the stains or sectioning should be
have the training in order to do the work. This can be docoumented
as in-house training or shown on their curriculum vitae (CV)/resume.
2) do you document troubleshooting (i.e. cooling blocks, use of
ammonia or glycerin, adding adhesive to waterbath (i.e.
gelatin)? Again the personnel sectioning should be able to
trouble-shoot problems during sectioning. If you write a SOP for every
little task performed in the lab you will be doing nothing but writing
SOP's and your manual would be huge!! Some common sense has to be
used when writing SOP's.
3) do you record expiration dates of reagents used in troubleshooting (i.e. ammonia,
gelatin)? If you make a reagent then yes you need to record the expiration
date on the reagent label and the reagent batch form.
The CFR's can be confusing and are left open to
vast interpretation. However, you are an experienced technician and the
SOP's can reflect that experience. If you write the SOP's so
tight, then if a tech is observed performing a SOP and does not dip the sections
exactly as it is written in the SOP, the lab could be cited. Give yourself
some breathing room!!
I hope this helps,
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