Home » Posts tagged 'guideline'
Tag Archives: guideline
DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
.....FOR BLOG HOME CLICK HEREFlag and hits
ORGANIC SPECTROSCOPY
SUBSCRIBE
Subscribe in a reader
Enter your email address:
Delivered by FeedBurner
Subscribe to New Drug Approvals by Email
Recent Comments
 | shivkr2 on SPSR Excellence Award 2025 – S… |
 | Bonkasaurus on Infigratinib phosphate |
 | PALOVAROTENE | ORGAN… on Palovarotene |
| Pfizer just purchase… on Temanogrel | |
| Pfizer To Cash In On… on Temanogrel |
European Pharmacopoeia Commission announces Strategy for Implementation of ICH Q3D
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.
………………..
clippings
-
Description:
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:Step 2b
EU:
Transmission to CHMP in June 2013, issued as EMA/CHMP/ICH/353369/2013. Deadline for comments: 31 December 2013
MHLW:
Released for consultation, 4 October 2013, PFSB/ELD. Deadline for comments: 29 November 2013
FDA:
Published in the Federal Register 23 October 2013, Vol. 78, No. 205, p. 63219-20. Deadline for comments: 23 December 2013
………………………….
Q3D Elemental Impurities – Food and Drug Administration
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
………………
Guideline for Elemental Impurities – ICH
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.
Final ICH M7 Guideline on Genotoxic Impurities published
GMP News: Final ICH M7 Guideline on Genotoxic Impurities published
On on 15 July 2014, the ICH issued the guideline M7 “Assessment and Control of DNA reactive (mutagenic) Impurities in Pharmaceuticals to limit Potential Carcinogenic Risk” as Step 4 document. in In the last step of the ICH process (Step 5) this guideline now has to be implemented in the national regulations in the three ICH regions Europe, United States and Japan. The final M7 Guideline was published exactly 17 months after the release of the draft consensus guideline (Step 2) in February 2013, where it could be commented in a 6-month period.
The guideline comprises information, how impurities in pharmaceutical products relative to their genotoxic potential have to be evaluated with the analysis of structure-activity relationships and how the critical toxicological threshold (threshold of toxicological concern TTC) has to be determined. In the individual chapters, some highly complex issues and scenarios are covered – as, for instance, the question why potentially genotoxic substances with similar molecular structure and probably the same mechanism of action should still not be combined for the calculation of the TTC. Another problem the Guideline tries to clarify is the different values of the TTC, depending on the duration of the use of the medicinal product.
The last section of the document contains a statement of the ICH, that due to its complexity the guideline has to be implemented in the respective national rules and regulations after 18 months only. However, the following exceptions apply to some requests:
- For the implementation of Ames tests the specifications of M7 have to be applied immediately. However, the Ames tests carried out before release of M7 need not be repeated.
- The development programmes having started phase 2b/3 prior to publication of M7 can be continued. The requirements for the execution of two quantitative analyses of structure-activity relations (section 6), for impurity assessment (section 5) and for the documentation (section 9) do not have to be considered, though.
- For a new marketing authorisation application which does not include the phase 2b/3 clinical trials, compliance with the aforementioned points is expected until 36 months after the publication of M7.
Compared to the previous Guideline version (Step 2) it now contains changes, clarifications and precisions in several parts. For a more detailed analysis of the new M7 Guideline please see one of our next newsletters.
The ECA will conduct the Impurities Forum 2014in Berlin, where a complete day will be dedicated to the implementation of Genotoxic Impurities ICH M7. On another day you will cover the implementation of Elemental Impurities ICH Q3D – whose finalisation is scheduled for September. The days can be booked separately or alternatively the entire 3 days of the Impurities Forum.
New Drug Approvals 