Hello everyone
Does anyone have a GLP -SOP sample ?
Thanks
Posted 28 April 2016 - 07:51 PM
Hello everyone
Does anyone have a GLP -SOP sample ?
Thanks
Posted 29 April 2016 - 04:52 PM
Hi Arshdeep ,
Welcome to IFSQN
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
Thanked by 1 Member:
|
|
0 members, 0 guests, 0 anonymous users