SOP Title: Procurement and Handling of Reference Standards/Impurity Standards

SOP Title: Procurement and Handling of Reference Standards/Impurity Standards         

1. Objective:

To lay down the procedure for Procurement and Handling of Reference Standards/Impurity Standards.

2. Scope:

This SOP is applicable for Procurement and Handling of Reference Standards/Impurity Standards in Quality Control Department.

3. Responsibility:

• Quality Control Department: To prepare and review the SOP. To follow the procedures laid down for Procurement and Handling of Reference Standards/Impurity Standards in Quality Control Department as per this SOP.
• Quality Assurance Department: To review and approve the SOP and Annexures.

 Accountability:

Head Quality Control Department, Head Quality Assurance Department

5. Procedure:

5.1	Procurement and Handling of Reference Standards/Impurity Standards :
5.1.1	Get the latest list of current lots of Reference Standards or Impurity Standards from the authorised agencies.
5.1.2	Pharmacopoeial grade Reference Standards or Impurity Standards shall be procured from Authorised Agency.
5.1.3	When any Reference Standard/Impurity Standard is received, the responsible analyst or officer should verify all the details like name, quantity received, Make, grade with the purchase order given to the respective agency.
5.1.4	Enter the details of Reference Standard/Impurity Standards received in “Reference Standard/Impurity Standard Receipt and Usage Record”
5.1.5	Assign the In-House Reference Number for Reference Standards and Impurity Standards as below:
5.1.6	For Reference Standards, assign Reference Number as ‘RSG/XX/YY-NN’. RS = Reference Standard G = Pharmacopoeial Grade ( I = IP , U = USP , B = BP  and E = EP) XX = Two alphabet from name of the Reference Standard YY = Last two digits of the current year NN = Serial number of received Reference Standard
5.1.7	For Impurity Standards, assign Reference Number as ‘ISG/XX/YY-NN’. IS = Impurity Standard G = Pharmacopoeial Grade ( I = IP , U = USP , B = BP  and E = EP) XX = Two alphabet from name of the Impurity Standard YY = Last two digits of the current year NN = Serial number of received Impurity Standard
5.1.8	Put the intact vial in a separate container that can easily traceable and label it as per Annexure.
5.1.9	Store the Reference Standard/Impurity Standard in refrigerator at 2°C to 8°C temperature or at specified storage conditions on containers or certificate.
5.1.10	Reference standard should be used during qualification of working standard as a reference. Reference standard also can be used for routine testing in case of unavailability of working standard.
5.1.11	Minimum amount of Reference standard shall be used for routine testing by decreasing at smaller dilutions.
	Note: When vials are removed from low temperature storage, they must be allowed to stand to attain Room temperature before use. Clean the outer Surface of vial with tissue paper before Use.
5.1.12	Wear safety masks, goggles, hand gloves while dispensing Reference Standard/Impurity Standard.
5.1.13	After each withdrawal, reseal the container and maintain “Reference Standard/Impurity Standard Receipt and Usage Record” as per Annexure
5.1.14	If expiry date is not given for reference standard or Impurity Standard then same can be used for up to 5 years from date of Manufacturing or from date of receipt whichever is earlier.
5.1.15	Discard the Reference Standard or Impurity by dissolving in water after its expiry and deface the label of the container.
5.1.16	Maintain list of Reference Standard/Impurity Standard as per Annexure
5.1.17	Immediately after use of Reference Standard/Impurity Standard, it should be restored back to its storage place.
5.1.18	During use of Reference Standard/Impurity Standard, do not put back the withdrawn material in the container.
5.1.19	For destruction of any Reference Standard/Impurity Standard, refer SOP of “Destruction of Laboratory Waste”.

 

6. Definitions / Abbreviations:

• Definitions :

 

• Abbreviations :

Abbreviation	Expansion
SOP	Standard Operating Procedure
QC	Quality Control
QA	Quality Assurance
AR	Analytical Reagent
No.	Number
IP	Indian Pharmacopoeia
BP	British Pharmacopoeia
USP	United States Pharmacopoeia
EP	European Pharmacopoeia

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.