GLP questions

From:Cathy Mayton

Dear Theleria, you asked the following questions regarding Good Laboratory Practices (GLP)  Standard Operating Procedures (SOP's).
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,
GLP Compliant Laboratory
Cathy A. Mayton
Project Director
Wasatch Histo Consultants, Inc.


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