Stage 4 Official Inquiry

The Stage 4 draft and the commentary are published in the revision document of each pharmacopeia in a section entitled International Harmonization. The draft is published in its entirety. 

The corresponding secretariats may have to add information essential to the understanding of the implementation of the texts (e.g., the description of an analytical procedure or of reagents that do not exist in the pharmacopeia) and a translation is added by the European and Japanese Pharmacopoeias. The style may be adapted to that of the pharmacopeia concerned or global style may be used. A pharmacopeia can add text, either to amplify some of the requirements with additional information or because national requirements and compendial policy dictate that the addition is necessary. However, there must be a clear indication that this additional information is not part of the harmonized document. This will avoid additional text being included after the harmonization process is completed, but will allow interested parties to review a complete text. The three pharmacopeias endeavor to publish the drafts simultaneously or as close together as possible. 

Comments regarding this draft are sent by readers of the revision document to their respective pharmacopeial secretariat, preferably within four months and at most within six months of its publication. 

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. 

The coordinating pharmacopeia reviews the comments received and prepares a draft harmonized document (Stage 5A draft), accompanied by a commentary discussing comments received regarding the previous text and providing reasons for action taken in response to those comments. 

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An Official Court of Inquiry was immediately appointed by the Secretary of State for Employment, Michael Foot, to establish the causes and circumstances of the disaster and to point out any lessons... to be learned therefrom. The essential problem faced by the Court was to determine what had caused the rupture of the by-pass. The possibilities investigated were i) rupture of the by-pass assembly through internal pressure ii) rupture of the assembly in two stages a small tear in the bellows (bellows B4) leading to an escape and a minor explosion causing final rupture and iii) rupture of the 8 inch line at the 50-inch split leading also to a minor explosion causing rupture of the by-pass assembly. ... 

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