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Does anyone have a GLP-SOP sample?

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arshdeep

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Posted 28 April 2016 - 07:51 PM

Hello everyone 

 

Does anyone have a GLP -SOP sample ? 

 

Thanks 



Ehab Nassar

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Posted 29 April 2016 - 04:52 PM

Hi Arshdeep ,

 

Welcome to IFSQN :welcome:

 

I do not know which type of laboratories you want to establish GLP .

Any way I prefer for the GLP to be a manual includes a group of SOP's.

SOP's are written procedures for a laboratories program. .

 

I do not know which system also you want to comply with , is it ISO 17025 , regulatory requirement , customer requirement .

 

Generally in GLP you should include the following components :

- Organization structure : including all the laboratory staff with their qualifications ,training history ,experience ,responsibilities and skills with training records and plans .

- Facility layout of the lab. with all required zoning if needed.

- Document control SOP

- List of all equipments you have , you should have a binder contains all the manuals of your equipments also you should history log for each equipment declares date of purchasing , all repairs ,..

- List of all Chemicals  with its MSDS and inventory control records.

- List of all tests performed in your laboratory ( physical ,chemical ,microbiological ,..) with a standard method SOP 

- Internal Control Plan (ICP ) : an SOP for each equipment and for each test method that to assure the accuracy and precision of the data  , e.g. you may had a pH  meter to be calibrated by an accredited supplier then you do daily check using the buffers  , or for certain test you may have a reference sample and run a test using repeatability and reproduceability methods .

- Hygiene , Sanitation and Pest control SOP.

- HazCom and HazMat training.

-Laboratory Safety SOP 

you may according to your scope add the sampling plan , testing frequency , 

 

The below links may help 

 

https://www.unido.or...l_guidebook.pdf

 

http://www.who.int/t...glp-trainee.pdf

 

http://cdn.intechope...fs-wm/22127.pdf

 

http://www.oecd.org/...practiceglp.htm

 

Good luck,

Ehab



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