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The publication of the final ICH Q3D guideline, which has been announced for September of this year, will lead to extensive revisions to chapters and monographs in the European Pharmacopoeia. Find out in what steps the Pharmacopoeia Commission will proceed.
GMP News: European Pharmacopoeia Commission announces Strategy for Implementation of ICH Q3D
In a press release from 7 July 2014, the ICH Steering Committee announced that the finalisation of the ICH Q3D Guideline on Elemental Impurities is planned for September 2014. A press release of the European Pharmacopoeia Commission entitled “The European Pharmacopoeia Commission validates its strategy regarding elemental impurities and the implementation plan of the upcoming ICH Q3D guideline” was released 11 days later. In this release, the Commission explains their approach with regard to the integration of the content of ICH Q3D in the European Pharmacopoeia. This is supposed to be done in the following steps:
- Chapter 5.20 of the Pharmacopoeia (“Metal catalysts or metal reagent residues”), which so far includes a literal rendition of the EMA Guideline “Specification limits for residues of metal catalysts or metal reagents“, will be replaced by the wording of the ICH Q3D Guideline, as soon as it is published as Step 4 document.
- Chapter 5.20 will only become legally binding when it is referenced in a pharmacopoeia monograph. For this purpose references to Chapter 5.20 are supposed to be inserted in the general monographs 2034 (“Substances for pharmaceutical use’) and 2619 (“Pharmaceutical preparations”). The time at which this will take place, has not yet been fixed and depends on the CHMP, which must formally decide to replace the EMA guideline by ICH Q3D in Chapter 5.20.
- In all individual monographs (except in those that relate to substances for veterinary medicinal products) references to Chapter 2.4.8 will be removed. This Chapter still describes wet chemical tests for heavy metals. A list of the affected monographs will appear in the January 2015 issue of the journal “Pharmeuropa”. The publication of the revised monographs is intended for the 9th edition of the European Pharmacopoeia with an implementation date of 1 January 2017.
- Chapter 2.4.20 (“Determination of metal catalyst and metal reagent residues”) covering the topics of “sample preparation” and “method suitability”, will be reviewed and adapted to the requirements according to ICH Q3D.
After the revision of the individual chapters and monographs it is at the discretion of the responsible quality control laboratories to choose an appropriate analytical strategy in accordance with the requirements of ICH Q3D.
The Q3D draft Guideline has been relased for consultation under Step 2B of the ICH process in July 2013.
This new guidance is proposed to provide a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients. The existing ICH Q3A Guideline classifies impurities as organic, inorganic, and residual solvents. The Q3A and Q3B Guidelines effectively address the requirements for organic impurities. An additional Guideline Q3C was developed to provide clarification of the requirements for residual solvents. The proposed new Guideline Q3D would provide similar clarification of the requirements for metals, which are included in the ICH inorganic impurities classification.Status:
Transmission to CHMP in June 2013, issued as EMA/CHMP/ICH/353369/2013. Deadline for comments: 31 December 2013
Released for consultation, 4 October 2013, PFSB/ELD. Deadline for comments: 29 November 2013
Published in the Federal Register 23 October 2013, Vol. 78, No. 205, p. 63219-20. Deadline for comments: 23 December 2013
Sep 30, 2013 – This document reached step 2B of the ICH Process on June 6, 2013. For questions … Q3D. Approval by the Steering Committee under Step 2b
DRAFT CONSENSUS GUIDELINE. GUIDELINE FOR ELEMENTAL IMPURITIES. Q3D. Current Step 2b version dated 26 July 2013. At Step 2 of the ICH Process, …
5 August 2013
The ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in July 2013 and now enters the consultation period (Step 3).
This new Guideline is proposed to provide a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients. The existing ICH Q3A Guideline classifies impurities as organic, inorganic, and residual solvents. The Q3A and Q3B Guidelines effectively address the requirements for organic impurities.
An additional Guideline Q3C was developed to provide clarification of the requirements for residual solvents.
The proposed new Guideline Q3D would provide similar clarification of the requirements for metals, which are included in the ICH inorganic impurities classification.
The draft Guideline is now available for download under the Quality Guideline page. ローテンシルト通販ニクソン腕時計You are invited to provide comments on the draft Guideline by e-mailing the ICH Secretariat. More details under the Open Consultation page.
Note that stakeholders from EU, US and Japan are encouraged to submit their comments to their respective Regulatory Authorities.
Japanese Pharmacopoeia and Japanese GMP Regulations available online
On Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) website, you can download documents on GMP as well as on marketing authorisations for medicinal products. An English version of the Japanese Pharmacopoeia (JP) is also available. You will find the direct links in the News.
On Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) website, you can find in the section “Regulations and Procedures” under the heading “GMP” requirements regarding the inspection of manufacturers of medicinal products and APIs who want to introduce their products into Japan.
Now, a document was supplemented in January 2014 which describes which documents have to be submitted to the Japanese Agency within a pre-approval inspection and/ or a periodical post-approval inspection.
Go to the PMDA webpage to get more information.
There, you can also access the current Japanese Pharmacopoeia Sixteenth Edition in English.
Source: PMDA, Japan