sop for handling of pharmacopoeial changes

sop for handling of pharmacopoeial changes

To lay down a procedure for “Handling of Pharmacopoeial Changes”.

2.0 SCOPE:
This SOP is applicable of procedure for “Handling of Pharmacopoeial Changes” in quality control department

Executive QC/Officer QC

Head- Quality Control


5.1 Procurement of Pharmacopoeial Publications: Pharmacopoeial publications include the following:

Pharmacopoeias: British Pharmacopoeia, European Pharmacopoeia, US Pharmacopeia and Indian Pharmacopoeia etc
Supplement/Addendums: British Pharmacopoeia, European Pharmacopoeia, US Pharmacopeia and Indian Pharmacopoeia etc.
Pharmacopoeial publications shall be procured by QC department.

List of Pharmacopoeia  as per Annexure-I

5.2 Providing information regarding pharmacopoeial or Inclusions updations

5.2.1 Quality Control department received new pharmacopoeias,  addendum.

5.2.2 After receipt of new pharmacopoeias, supplements / addendum check for following changes:

5.2.3 Inclusions or omission of Monograph

5.2.4 Revision of Monograph

5.2.5  General Chapter

5.2.6 Appendices

5.2.7  Compendial Testing procedures

5.2.8  If there is any change in the monograph, verify the following:

5.2.9  Change in limits (specification)

5.2.10  Change in method of analysis

5.2.10 Change in reference standards / reagents /chemicals

5.2.10 Addition or deletion of instruments / equipments

5.2.10 Change in chromatographic conditions including columns.

5.2.10 Change in equipments / instrument accessories

5.2.10 If there is a change in general chapters verify for the following:

5.2.10 Calibration procedures.

5.2.10 Instrument / equipments requirements

5.2.10 General testing procedures

5.2.10 Interpretation of monographs, etc.

5.2.10 If any monograph of interest is published in the pharmacopoeias or in addendum / supplements

and if there is any change in the monograph, general test procedures, information will be given to the following departments:
Head, Quality Assurance   Head, Quality Control

QC Officer / designee shall enlist out the Product / Material name which shall be affected by the pharmacopoeial revision.

Quality control department shall procure chemicals /Reagents/Reference standards and HPLC columns as per pharmacopoeial changes.
QC Officer / designee shall intimate to QA dept and issue the product / material from QA dept to test as per changes in the pharmacopoeia.
Quality control shall analyzed the product/materials as per current pharmacopoeial changes.

If the material passes the specification as per changed pharmacopoeial limit then all the changes shall be brought into the Specification, STP and GTP through Change control.
After approval of the change control relevant Specification, STP and GTP shall be revised.

Training shall be imparted to all concerned persons of QC department after incorporating all the changes in the Specification, STP and GTP.
Old Specification, STP and GTP shall be retrieved in QA department.

If Product/materials not passes as per current pharmacopoeial changes shall inform to Quality assurance for further action.
In case of Raw materials, Quality assurance shall provide specification to purchase department to procure the materials as per current pharmacopoeial revision.


Pvt. : Private

Ltd : Limited

QC : Quality Control

SOP : Standard Operating Procedure No. : Number

GTP : General Testing Procedure

STP : Standard Testing Procedure


Annexures Name of Annexure Format No
Annexure – I List of Pharmacopoeia

• Controlled Copy      Quality Control Department
• Master Copy            Quality Assurance Department


in House


Revision No. Change Control No. Details of Changes Reason of Changes Effective Date Done By
00 Not Applicable Not Applicable New SOP


S. No. Name of Pharmacopoeia Year of Publication


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