To lay down a standard procedure of procurement, storage, usage & destruction of reference standard.
This SOP is applicable for the procurement, storage, usage & destruction of reference standards in Quality Control Department at ( Name of Company)
Officers / Executive – Quality Control shall be responsible for complies of this SOP
Manager- Quality Control and Head QA shall be accountable for compliance of this SOP.
Format for Reference Standard Receiving Record Attachment-I
Format for Reference Standard Consumption and Destruction Record Attachment-II
6.1 STANDARDS ARE CATEGORIZED IN FOUR TYPES:
6.1.1 Pharmacopoeial Reference Standard: These are for the products mentioned in the Pharmacopoeia i.e. USP, BP, and IP
6.1.2 Non-Pharmacopoeial Reference Standard: These are for the products, which are not mentioned in the Pharmacopoeia.
6.1.3 Working Standard (WS): Working standards are developed in house and qualified against the Reference Standard.
6.1.4 Qualified working standard: Received from outside vendor.
6.2 Procurement and storage of Reference Standard:
6.2.1 Pharmacopoeia Reference Standards are procured from the authorized Pharmacopoeial agencies.
6.2.2 Non-Pharmacopoeial Reference Standards are procured from the vendor of those materials.
6.3 Reference Standard is procured whenever:
6.3.1 New lot number of Pharmacopoeial reference standard is released by the Pharmacopoeial agencies.
6.3.2 Non-Pharmacopoeial reference standard is expired.
6.3.3 New product is introduced in the facility.
6.3.4 Keep track of the emergence of new lots number of reference standard in the publications of Pharmacopoeial agencies or in web site of respective Pharmacopoeial agencies.
6.3.5 After receiving the reference standard, record the detail in the reference standard receiving record as per Format- SOP/QC/008/FT01-00.
6.3.6 Receive reference standard (Non Pharmacopoeial) from vendor and checks for the availability of certificate of analysis supplied with the standard.
6.4.7 Store the reference standard vial in a desiccator and keep it in the refrigerator at temperature 2-8°C or as prescribed.
6.4 Usage & Destruction of Reference Standard:
6.4.1 During opening of Reference Standard container, record the detail in Format- SOP/QC/008/F01-00.
6.4.2 Record the quantity used for the testing or for the Qualification of working standard in reference standard usage record as per Format- SOP/QC/008/F02-00 and keep the accountability of reference standard quantity.
6.4.3 During usage of reference standard, precautions should be taken such that contents of the vial are not contaminated with other products or any spillage should not occur.
6.4.4 Seal the reference standard vial after usage & keep in the designated place.
6.4.5 Ensure that reference standard quantity is sufficient for next qualification. If not indent for further procurement.
6.4.6 If the reference standard is expired (for non Pharmacopoeial) and / or replaced (for Pharmacopoeial) by a new lot of reference standard, destroy the previous standard by solubilising in a suitable solvent and discard the solution.
6.4.7 Record the destruction of reference standard consumption and destruction record as per Attachment-II.
SOP: Standard Operating Procedure
QC: Quality Control.
°C: Degree centigrade
WS: Working standard
RS: Reference standard/ Reference substance
QA: Quality Assurance
USP: United state Pharmacopoeia
BP: British Pharmacopoeia
IP: Indian Pharmacopoeia
9.0 DISTRIBUTION LIST:
Quality Assurance Department
Quality Control Department
10.0 HISTORY OF REVISION:
|Version No.||Date of Revision||Reason for Revision|
|Title||:||REFERENCE STANDARD CONSUMPTION AND DESTRUCTION RECORD|
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|Balance Quantity||Purpose||Used By||Destruction Qty.||Destructed by||Checked By|