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: ______________________

Date of receiving

Name of material

Batch/ Lot No.

Grade

Use before

Qty. received

Potency

LOD

Qty. used

Qty. remains

Sign of analyst

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Annexure: 2

Working standard Log

Name of material: ______________________

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Annexure: 3

Vial Issuance Record for Working Standard

Working Standard: _______________________

Date

Total No. of vial prepared

No. of vials issued

Balance vials

Issued by

Received by

Remarks

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

9.0  ABBREVIATIONS:

Abbreviation

Expanded Form

S

Standard operating procedure

&

And

%

percentage

 

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