SOP on pharmacopeial updation of documents as per the pharmacopeial changes

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1.0 Objective:

To lay down a procedure for pharmacopeial updation of documents as per the pharmacopeial changes.

2.0 Scope:

This procedure is applicable to pharmacopeial updation of documents as per the pharmacopeial changes at pharmaceutical formulation plant.

3.0 Responsibility:

QC Chemist or above

QA officer or above

4.0 Accountability:

Head Quality Control

Head Quality Assurance

5.0 Abbreviation:

  • SOP :            Standard Operating Procedure
  • QC :              Quality Control
  • SOP :            Standard Operating Procedure
  • QC :              Quality Control
  • QA :              Quality Assurance
  • US :              United States
  • STP :            Standard testing Procedure
  • GTP :           General testing Procedure
  • No.:              Number
  • GN :             General

6.0 Procedure:

6.1 Procurement of pharmacopieal publications:

6.1.1 Pharmacopoeial publications include the following:

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

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

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

6.2 Providing information regarding pharmacopoeial updations or Inclusions:

6.2.1 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:

6.2.1.1 Quality Assurance

6.3 Quality Control

6.4 Quality Control department received new pharmacopoeias, supplements / addendum

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

6.5.1 Inclusion or omission of monographs.

6.5.2 Revision of monographs

6.5.3 General chapters.

6.5.4 Appendices

6.5.5 Compendial testing procedures.

6.6 If there is change in monograph, verify the following:

6.6.1 Change in limits (specification).

6.6.2 Change in method of analysis.

6.6.3 Change in reference standards / reagents /chemicals.

6.6.4 Addition or deletion of instruments / equipments.

6.6.5 Change in chromatographic conditions including columns.

6.6.6 Change in equipments / instrument accessories.

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

6.7.1 Calibration procedures.

6.7.2 Instrument / equipments requirements.

6.7.3 General testing procedures.

6.7.4 Interpretation of monographs, etc.

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

7.0 List of Annexure / Formats:

Not applicable

8.0 References:

Not applicable

9.0       Distribution

7.1   Master Copy                                     : Documentation Cell (Quality Assurance)

7.2   Controlled Copies                            : Quality Assurance, Quality Control, Microbiology-QC

10.0 History

     Date    Revision Number                       Reason for Revision
                       New SOP

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