Handling Of Reference And Working Standards
1.0 OBJECTIVE:
To
lay down a procedure handling of reference and working standards.
2.0 SCOPE:
This
SOP is applicable for handling of reference and working standards.
3.0 RESPONSIBILITY:
3.1
Officer/ Executive
Q.C.
4.0 ACCOUNTABILITY:
4.1
Manager Q.C.
4.2
Head of the Q.C Department.
5.0 PROCEDURE:
5.1
Procurement of
reference standards and impurities.
5.2
Reference
standards and impurities related to the product shall be procured of USP, BP
and in-house standard.
5.3
Record of all
procurement shall be maintained.
5.4
Stock of all
reference standards shall be maintained under recommended storage condition.
5.5
Usage record of
reference standards and impurities shall be maintained.
5.6
Reference standard
shall be use development of working standard.
5.7
Working standard
shall be prepared by comparative study of purest form raw materials.
5.7.1
For development of
working standard by HPLC /UV/ Auto titrator three analysis shall be performed
using reference standard. Average result of comparative study shall be used for
routine analysis.
5.7.2
Use before working
standard maximum once in a year or 6 month for less stable products.
5.7.3
12 vials shall be
prepared for the use for each working standard for one year period.
5.7.4
Store working
standard below 25oC and humidity less than 60% cool and dark place
or light resistant container.
5.7.5
Following details
shall be maintained on each vial.
|
Working
Standard |
|
Product Name: XYZ W
S No.: WS/XX/001 Assay: 00.00 % as such basis LOD
/ Water: 0.00% Vial
No.: 01 Effective
Date: DD/MM/YYYY Use
Before: DD/MM/YYYY Issue
date: DD/MM/YYYY |
Where,
XYZ is a product name,
WS
is working standard,
XX
is a product code,
001
is a serial number.
5.7.6
All working
standard container shall be store under refrigerated conditions (2oC-8oC).
5.7.7
One opened vial
shall be used only for 30 day from the date of opening.
5.7.8
Each opened vial
shall be maintained under desiccators at room temperature.
5.7.9
After 30 days of
use, it shall be discarded and a fresh vial will be opened for use and
maintained in desiccators.
5.8
All log books/
registers shall have an approved printed format.
5.9
The log books/
registers shall be issued and maintained on manual basis.
5.10 The
details of issue and maintenance of the records shall be with the
documentation.
5.11 The
record shall be maintained in the documentation cell for reference purpose for
5 years.
5.12 Q.A
Manager shall ensure the reconciliation and disposition of the achieved log
books/ registers, and authorize the disposition.
5.13 Details
of working standard preparation and use shall be maintained.
6.0 REVISION LOG:
|
Revision No. |
Effective Date |
Reason |
|
00 |
|
New
SOP |
7.0 REFERENCES:
7.1
Not Applicable.
8.0 ANNEXURES:
Annexure 1:Reference
Standard Log
Annexure 2:Working
standard Log
Annexure 3: Vial
Issuance Record for Working Standard
Annexure:
1
Reference
Standard Log
Name of material:
______________________
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Date of receiving |
Name of material |
Batch/ Lot No. |
Grade |
Use before |
Qty. received |
Potency |
LOD |
Qty. used |
Qty. remains |
Sign of analyst |
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Annexure:
2
Working
standard Log
Name of material:
______________________
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Date |
A.R. No. |
Batch/ Lot No. |
Mfg date |
Exp. date |
Use before |
Qty. vials prepared |
Potency |
LOD |
Effective date |
Sign of analyst |
Checked by |
Remarks |
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Annexure:
3
Vial Issuance Record for
Working Standard
Working
Standard: _______________________
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Date |
Total No. of vial prepared |
No. of vials issued |
Balance vials |
Issued by |
Received by |
Remarks |
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9.0 ABBREVIATIONS:
|
Abbreviation |
Expanded Form |
|
S |
Standard operating
procedure |
|
& |
And |
|
% |
percentage |