1.0 OBJECTIVETo collect and store pre-decided sample quantity from each raw material received for the formulation plant except Acids, Alkalies & Solvents.
2.0 SCOPEThis procedure is applicable to all raw material received for the formulation plant except Acids, Alkalies and solvents.
3.0 RESPONSIBILITY3.1 Doing : Technical Assistant/Executive
3.2 Checking : Executive/ Manager
4.0 ACCOUNTABILITYHead of the Department
5.0 PROCEDURE5.1 Collect required quantity of retain sample from raw material received.
5.2 Take the sample in plain & black Poly bags (In case if light sensitive material).
5.2 Keep this bag in the air tight plastic container.
5.3 Place the label on the plastic container having following Details.
RETAIN SAMPLENAME OF Material : ______________________
BATCH NO : ______________________
QUANTITY : ______________________
DATE : ______________________ A.R. No.:_______________
5.5 Enter the data in the ‘Retain sample register’ as per following details.
Name of Raw Material :
Qty Sampled :
Date of preparation :
Storage condition :
5.6 Keep the plastic container in the box number as specified in the register.
5.7 Store the retain sample container for 10 years as per list of storage condition available in Q.C. Dept.
5.5 Destroy the retain samples after 10 years.
5.6 Prepare the list of RM to be destroyed and get the approval for the same.
5.7 For destruction of retain samples soak the material in water or collect the liquid material & drain by flushing with excess of water.
5.5 Transfer the empty bottles, containers to scrap area as per Ref. S.O.P.
5.6 Preserve the destruction record for 5 years after the date on which they are destroyed.
Related: SOP for Retesting Schedule of Raw Material
6.0 ABBREVIATIONA.R.No. = Analytical Report number
Sr. No. =Serial number
Qty = Quantity
Q.C. = Quality Control
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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