QualityGuidances

1.0  OBJECTIVE

To lay down a standard procedure of procurement, storage, usage & destruction of reference standard.

2.0 SCOPE

This SOP is applicable for the procurement, storage, usage & destruction of reference standards in Quality Control Department at

3.0 RESPONSIBILITY

3.1    Officers / Executive – Quality Control shall be responsible for complies of this SOP

4.0    ACCOUNTABILITY

4.1    Manager- Quality Control and Head QA shall be accountable for compliance of this SOP.

• ATTACHMENTS

Format for Reference Standard Receiving Record                                      Attachment-I

Format for Reference Standard Consumption and Destruction Record      Attachment-II

• PROCEDURE
  • STANDARDS ARE CATEGORIZED IN FOUR TYPES
    • Pharmacopoeial Reference Standard: These are for the products mentioned in the Pharmacopoeia i.e. USP, BP, and IP
    • Non-Pharmacopoeial Reference Standard: These are for the products, which are not mentioned in the Pharmacopoeia.
    • Working Standard (WS): Working standards are developed in house and qualified against the Reference Standard.
    • Qualified working standard: Received from outside vendor.
  • 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.

• Reference Standard is procured whenever.
  • New lot number of Pharmacopoeial reference standard is released by the Pharmacopoeial agencies.
  • Non-Pharmacopoeial reference standard is expired.
  • New product is introduced in the facility.
  • 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.
  • After receiving the reference standard, record the detail in the reference standard receiving record as per Format- SOP/QC/008/FT01-00.
  • Receive reference standard (Non Pharmacopoeial) from vendor and checks for the availability of certificate of analysis supplied with the standard.
  • Store the reference standard vial in a desiccator and keep it in the refrigerator at temperature 2-8°C or as prescribed.
• Usage & Destruction of Reference Standard:
  • During opening of Reference Standard container, record the detail in Format- SOP/QC/008/FT01-00.
  • 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/FT02-00 and keep the accountability of reference standard quantity.
  • 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.
  • Seal the reference standard vial after usage & keep in the designated place.
  • Ensure that reference standard quantity is sufficient for next qualification. If not indent for further procurement.
  • 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.
  • Record the destruction of reference standard consumption and destruction record as per Format-02.
• REFERENCES

In-house

• ABBREVIATIONS

SOP: Standard Operating Procedure

QC: Quality Control.

°C: Degree centigrade

WS: Working standard

RS: Reference standard/ Reference substance

FT: Format.

QA: Quality Assurance

USP: United state Pharmacopoeia

BP: British Pharmacopoeia

IP: Indian Pharmacopoeia

• DISTRIBUTION LIST

   Quality Assurance Department

Quality Control Department

10.0  HISTORY OF REVISION

Version No.

Date of Revision

Reason for Revision

Attachment -1

Sr. No.	Name of Std	Date of receipt	Lot No.	Make	Storage condition	Received by	Date of Opening	Opened By	Checked By

 

Name of Reference Standard:                                                         Lot No. :

Make:                                                                                                Quantity Received:

 

 

Sr. No.	Date	Quantity Used	Balance Quantity	Purpose	Used By	Destruction Qty.	Destructed by	Checked By