Pharmacopeias coordinating

Supplements to USP24-NF19 contain updates of an informational chapter by this name. It lists all of the projects imdertaken by PDG. Tables 2 and 3 list the projects as of Jan, 1, 2000, and identify the coordinating pharmacopeia. However, the official status of each project is not reported since this changes with each supplement. 

On the basis of an inquiry among its users, the PDG identifies subjects to be harmonized among PDG pharmacopeias and nominates a coordinating pharmacopeia for each subject. 

The PDG distributes the work by consensus among the three pharmacopeias and strives for a balance in the distribution of assignments to coordinating pharmacopeias. 

For a subject to be harmonized retrospectively, the coordinating pharmacopeia collects the information on the existing specifications in the three pharmacopeias, on the grades of products marketed, and on the potential analytical procedures. 

The coordinating pharmacopeia prepares a draft monograph or chapter, accompanied by a report giving the rationale for the proposal with validation data. 

Stage 2 ends with the proposal draft, which is mentioned in this procedure as a Stage 3 draft. The Stage 3 draft, accompanied by supporting comments or data that explain the reasons for each test procedure or limit proposed, is sent by the coordinating pharmacopeia to the secretariats of the other two PDG pharmacopeias. 

Comments by the experts resulting from this preliminary survey are sent to their respective pharmacopeial secretariat, preferably within two months. However, the comment period should not exceed four months. Within two months of receipt of the comments, the pharmacopeial secretariat should consolidate the comments and forward them to the coordinating pharmacopeia. 

The coordinating pharmacopeia reviews the comments received and prepares a harmonized document (Stage 4 draft) accompanied by a commentary discussing comments received about the previous text and providing reasons for action taken in response to those comments. 

Each pharmacopeia analyzes the comments received and submits its consolidated comments to the coordinating pharmacopeia within two months of the end of the review or comment period. 

When agreement is reached, the 5B draft is sent by the coordinating pharmacopeia to the other pharmacopeias no later than four weeks before a PDG meeting for final confirmation. The document is then presented for sign-off at the PDG meeting. This document includes nonharmonized attributes clearly marked as such. 

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