Standard Operating Procedure for Procurement and Handling of Pharmacopoeial Revisions

1.0 Purpose:

The purpose of this document is to describe the procedure for procurement of pharmacopoeias and handling their revisions.

2.0 Scope:

This procedure is applicable to all pharmacopoeias and their supplements used at [company name].

3.0 Responsibility:

Executive Regulatory affairs: To intimate pharmacopeial revisions to QC.

Manager QC/Designee: Procurement, receipt of pharmacopeial revisions, intimating the receipt, review of changes & implementation of changes (if any)

Executive QA/ Designee: Archival of obsolete versions.

4.0 Definition:

Pharmacopoeia:

i) A book containing an official list of the medicinal drug together with the articles on their preparation

ii) An official book containing list of approved drugs and medicines with information regarding their properties, preparation and use.                                                                                                             

5.0 Procedure:

5.1. Procurement and receipt of the pharmacopoeias:

5.1.1. Regulatory affairs department shall keep Quality control department informed regarding revisions of the pharmacopoeias.

5.1.2. Revision information of the pharmacopoeia shall be updated on internet at the following official websites.

For BP: www.pharmacopoeia.org.uk 

For USP: http://www.usp.org 

For IP:  www.ipc.gov.in  

For EP: http://www.edqm.eu

Or authorized official pharmacopeia suppliers.

5.1.3. QC Manager or designee shall raise the indent / purchase requisition for required pharmacopoeia / supplements / addendum (CD drive).

5.1.4. All the detail of the pharmacopoeia volume number / supplement number / addendum number shall be mentioned in the indent / purchase requisition.

5.1.5. QC-Manager or designee shall approve and sent the indent / purchase requisition to the purchase department.

5.1.6. QC- Manager or designee shall receive the pharmacopoeia (CD drive) and intimates the receipt of the same to all the concerned departments including IT department for installation of the same.

5.1.7. A list of all pharmacopoeias with their supplements / addendum shall be prepared with the name of the pharmacopoeia (soft copy), supplement number and or version number with the effective date. 

5.1.8. IT department shall be give access of pharmacopoeia to all the concerned person’s. 

Note: All current Pharmacopoeia should be available with Quality Control department either as hard copy or online.

5.2. Review of the new pharmacopoeial edition / supplement.

5.2.1. After receipt of the new editions of pharmacopoeia, supplements (CD drive) etc. concerned quality Control personnel shall review the changes as applicable. 

5.2.2. Depending upon the changes observed in the new versions or supplements, revision of related documents (e.g. Specification and AWR) shall be made. 

5.2.3. The revisions of documents related to the pharmacopoeial changes shall be done in such a manner that the testing at QC as per new edition shall be applicable immediately after edition effective date. 

5.2.4. In case of any delay in this procedure, all analysis shall be done within the period of revision of pharmacopoeia and revision of the related documents shall be reviewed for compliance with the new revised specification & methods of analysis in the pharmacopoeia.

6.0 Acceptance Criteria:

Not Applicable

7.0 Frequency:

As and when require during the quality control operations

8.0 Format for recording: 

Not applicable