SOP on Pharmacopeial updation of documents as per the Pharmacopeial changes

Objective: To lay down a procedure for Pharmacopeial updation of documents as per the Pharmacopeial changes.

Scope: This procedure is applicable to Pharmacopeial updation of documents as per the Pharmacopeial changes..

Responsibility: QC Chemist or above & QA officer or above

Accountability: Head Quality Control & Head Quality Assurance

Procedure:

Procurement of Pharmacopeial publications:

Pharmacopoeial publications include the following:

Pharmacopoeias: British Pharmacopoeia, European Pharmacopoeia, US Pharmacopeia and Indian Pharmacopoeia etc.

Supplements / Addendums: European Pharmacopoeia, British Pharmacopoeia, US Pharmacopeia and Indian Pharmacopoeia etc.

Forums: European Pharmacopoeia, British Pharmacopeia and US Pharmacopoeia etc.

Providing information regarding pharmacopoeial updations or Inclusions:

If any monograph of interest is published in the pharmacopoeias or in addendum / supplements, or if there is any change in the monograph , general test procedures, information will be given to the following departments:

Quality Assurance

Quality Control

Quality Control department received new pharmacopoeias, supplements / addendum

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

Inclusion or omission of monographs.
Revision of monographs
General chapters.
Compendial testing procedures.

If there is change in monograph, verify the following:

Change in limits (specification).
Change in method of analysis.
Change in reference standards / reagents /chemicals.
Addition or deletion of instruments / equipments.
Change in chromatographic conditions including columns.
Change in equipments / instrument accessories.

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

Calibration procedures.
Instrument / equipments requirements.
General testing procedures.
Interpretation of monographs, etc.

If there is any change in the monograph / general test procedure of interest, then QA / QC Department Head, shall give the training as per SOP and respective STPs, Specifications, SOPs, GTPs and other documents shall be revised as per the changes.

List of Annexure / Formats: Not applicable

References: Not applicable

Reason for Revision: Not applicable due to new SOP.