SOP for procurement and handling of Reference standards

I.                   PURPOSE

To define the procedure for procurement and handling of Reference standards.

II.                SCOPE

This SOP is applicable to Reference Standards in Quality Control department,

III.             RESPONSIBILITY

Executive - Quality Control

IV.             ACCOUNTABILITY

Incharge - Quality Control

V.                PROCEDURE

1.0              The reference standard of USP, EPCRS and BPCRS should be procured from respective agencies as mentioned in the respective pharmacopoeia.

2.0       On receipt of the reference standard, check the details on the label and enter the details in  ‘Reference Standard Usage Record’ Format No.: F01 /SOPQC017-00.

2.0              Incharge Q.C should ensure that the entry is done after each withdrawal.

3.0       Ensure that reference standards in use are of a current lot.

4.0       Check the quantity of reference standard every six months. If the reference standard quantity is not sufficient for future use, then Q.C. executive /in-charge should arrange for procurement of reference standard.

5.0       Reference standards should be stored as per recommended conditions.

6.0       When ever a new lot / batch entered in distribution, indent for current lot of reference standard, after receiving the current lot , discard the old reference standard and enter the details in the above record.

7.0        List of Formats

Format No.	Title
F01/SOPQC017-00	Reference Standard Usage Record

VI.       REVISION SUMMARY

Version No.	Revised on	Reason for Revision
00	NA	NA

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