PROCUREMENT, HANDLING, STORAGE AND DESTRUCTION OF REFERENCE STANDARDS

• PROCEDURE:
• Procurement:
• Reference standards shall be procured as mentioned in individual monograph.
• Procure the reference standard of current lot / Batch. Number from the source.
• To know the current lot of reference standard, the reference can be checked from current catalogue or download the current catalogue from the following websites.
• For USPRS – www.USP.ORG
• For BPCRS – www.BPCLAB.CO.UK
• For EPCRS – www.PHEUR.ORG
• After receiving the reference standards, it shall be checked for the details on the label, COA and MSDS.
• Record the details in the reference standard stock Register.
• Reference standards for Non-Pharmacopoeia products which are not available with any Regulatory authority shall be procured from R & D or related manufacturer along with COA and supporting data.
• Record the details in the Reference Standard stock Register.Fresh Reference Standards shall be procured in case existing Reference Standard shall get exhausted or if the regulatory authorities change the current Batch.
• Number / Lot Number and the same details shall be updated in reference standard stock register.If new catalogue has updated check reference standards against current catalogue and if any changes found in lot numbers of reference standards same shall be discarded after validity of the existing catalogue from the reference standard stock register.
• HANDLING:
• The Usage and consumption of reference standards shall be recorded in Annexure-II.
• Wherever reference standard is required to be dried before usage, transfer a sufficient quantity in to a clean dry bottle, and then keep for drying. Do not keep the original container in oven for drying.
• Do not dry a standard repeatedly at temperature above 25 ° C.
• Note: When stored at 2-8°C or –20°C, before usage allow the standard to attain room temperature.

• STORAGE:
• Unless specified the Reference standards shall be stored in a refrigerator at temperature 2-8°C.
• All Reference Standards shall be stored in their original stopper containers, away from heat and protected from light.
• DESTRUCTION: The details of destruction shall be entered in reference standard stock register.

• ANNEXURES: 

Annexure-I
SOURCES OF REFERENCE STANDARDS

Annexure-II
REFERENCE STANDARD STOCK REGISTER