Procedure for Receipt, Issue and Control of Reference and Impurity standards.

1.0 OBJECTIVE

To lay down the procedure for Receipt, Issue and Control of Reference and Impurity standards.

2.0 SCOPE

This SOP is applicable for receipt, issue and control of reference and impurity standards in  Company Name.

3.0 BACKGROUND

NIL

4.0 RESPONSIBILITY

4.1 All Analytical research personnel shall follow the SOP. 

4.2 Group leader of Analytical research to ensure the procedures to be followed.      4.3 Head Analytical research or his designee to ensure overall compliance. 

5.0 PROCEDURE

5.1 Analytical research personnel shall list out and procure the required reference standards and Impurity standards.

5.2 Use the lot number for reference / impurity standards, which are considered official. ( Refer current catalogue of USP, EP, BP and JP etc.. )

5.3 After receiving reference or impurity standards the details shall be checked by group leader for its lot number, pack size, quantity received and for physical  observation of container.

5.4 Group leader shall check for following information on the label, MSDS & current catalogue of reference / impurity standard and shall enter the details in the  “ Register for Reference / Impurity standard ” (Annexure-1).

* Name of the reference standard / impurity standard 

* Lot number (or) Batch number

* Potency (if applicable)

* Quantity

* Storage condition

* Instruction given if any ( i.e. drying details, moisture content determination etc..)

* Precaution to be taken, etc..

5.5 Reference  / Impurity standards shall be stored as per the storage condition as mentioned on label or MSDS or current catalogue of USP/ EP / BP or JP. If storage condition is not available on the label or MSDS or current catalogue, the reference / impurity standard shall be stored in “dry place” storage condition.

5.6 Precautions or instructions given on label, MSDS or current catalogue shall be followed.

5.7 The MSDS / COA received along with reference / impurity standard shall be filed in the respective files.

5.8 Whenever any reference standard or impurity standard is to required for analysis group leader shall issue and enter the details in the “Stock card for Reference /  Impurity Standard” (Annexure-2).

5.9 After using the reference or Impurity standard vial, it shall be immediately tightly closed and wrapped with parafilm and kept in the respective place. Usage details shall be entered by analyst in the “Stock card for Reference  / Impurity Standard “(Annexure-2) and the usage details shall be verified by the group leader.

5.10 Expired lots of reference and impurity standards shall be destroyed and destruction details shall be recorded in “ Stock card  for Reference / Impurity Standard ”(Annexure-2).

5.11 Unless a reference standard label states a specific potency or content, the reference standard is taken as being 100.0% pure for the purpose for which it is provided.

6.0 VERSION HISTORY

7.0 ANNEXRES

Annexure-1-Register for Reference / Impurity Standard

Annexure-2-Stock card for Reference / Impurity Standard