This document summarizes the harmonization by the International Conference on Harmonisation of disintegration test methods for tablets and capsules across regulatory regions. It recommends that the pharmacopoeial texts from the European Pharmacopoeia, Japanese Pharmacopoeia, and United States Pharmacopeia can be used interchangeably for tablets and capsules under 18mm, except for delayed-release or enteric formulations. It provides considerations for implementation including any necessary regulatory procedures and specifies that acceptance criteria are set individually for each product.
Inactive ingredient guide which is mainly useful for drug formulation departments where to determine the various excipients with different concentration is used and accordingly choosen dosage form as well as route of administration. By which we can also find out if any adulterated excipients is present or not.
Inactive ingredient guide which is mainly useful for drug formulation departments where to determine the various excipients with different concentration is used and accordingly choosen dosage form as well as route of administration. By which we can also find out if any adulterated excipients is present or not.
Phụ lục 3. Các chế định trong việc đánh giá sản phẩm sinh học trị liệu có nguồn gốc DNA tái tổ hợp. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU.
European Medicines Agency has issued a new guidelines describing stability testing requirements for variations to a marketing authorisation after approval, setting out the differing requirements for changes to active pharmaceutical ingredients (API) and finished dosage form production.
Manufacturers in the EU making changes to their manufacturing processes will have to submit additional stability data, according to these new guidelines.
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2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
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Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Thinking of getting a dog? Be aware that breeds like Pit Bulls, Rottweilers, and German Shepherds can be loyal and dangerous. Proper training and socialization are crucial to preventing aggressive behaviors. Ensure safety by understanding their needs and always supervising interactions. Stay safe, and enjoy your furry friends!
A review of the growth of the Israel Genealogy Research Association Database Collection for the last 12 months. Our collection is now passed the 3 million mark and still growing. See which archives have contributed the most. See the different types of records we have, and which years have had records added. You can also see what we have for the future.
How to Build a Module in Odoo 17 Using the Scaffold MethodCeline George
Odoo provides an option for creating a module by using a single line command. By using this command the user can make a whole structure of a module. It is very easy for a beginner to make a module. There is no need to make each file manually. This slide will show how to create a module using the scaffold method.
Exploiting Artificial Intelligence for Empowering Researchers and Faculty, In...Dr. Vinod Kumar Kanvaria
Exploiting Artificial Intelligence for Empowering Researchers and Faculty,
International FDP on Fundamentals of Research in Social Sciences
at Integral University, Lucknow, 06.06.2024
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A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
How to Add Chatter in the odoo 17 ERP ModuleCeline George
In Odoo, the chatter is like a chat tool that helps you work together on records. You can leave notes and track things, making it easier to talk with your team and partners. Inside chatter, all communication history, activity, and changes will be displayed.
MATATAG CURRICULUM: ASSESSING THE READINESS OF ELEM. PUBLIC SCHOOL TEACHERS I...NelTorrente
In this research, it concludes that while the readiness of teachers in Caloocan City to implement the MATATAG Curriculum is generally positive, targeted efforts in professional development, resource distribution, support networks, and comprehensive preparation can address the existing gaps and ensure successful curriculum implementation.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
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INTERNATIONAL
CONFERENCE
ON
HARMONISATION
OF
TECHNICAL
REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
ICH HARMONISED TRIPARTITE GUIDELINE
EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL
TEXTS FOR USE IN THE ICH REGIONS ON
ISINTEGRATION
DISINTEGRATION TEST GENERAL CHAPTER
Q4B ANNEX 5(R1)
Current Step 4 version
dated 27 September 2010
This Guideline has been developed by the appropriate ICH Expert Working Group
and has been subject to consultation by the regulatory parties, in accordance with
the ICH Process. At Step 4 of the Process the final draft is recommended for
adoption to the regulatory bodies of the European Union, Japan and USA.
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Q4B Annex 5(R1)
5(R1)
Document History
Code
History
Date
Q4B Annex 5
Approval by the Steering Committee under Step 2 and
release for public consultation.
5 June
2008
Q4B Annex 5
Approval by the Steering Committee under Step 4 and
recommendation for adoption to the three ICH regulatory
bodies.
10 June
2009
Current Step 4 version
Q4B Annex
5(R1)
Integration of the Health Canada Interchangeability
Statement under Section 4.5 after approval by the Steering
Committee.
27 September
2010
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EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS
FOR USE IN THE ICH REGIONS
ON
DISINTEGRATION TEST GENERAL CHAPTER
ICH Harmonised Tripartite Guideline
Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting
on 10 June 2009, this guideline is recommended for
adoption to the three regulatory parties to ICH
(This annex was revised -R1- to include the Interchangeability Statement from Health
Canada on September 27, 2010)
TABLE OF CONTENTS
1.
INTRODUCTION........................................................................................
INTRODUCTION........................................................................................ 1
................................................................
2.
OUTCOME..........................................................................................
................................................................
Q4B OUTCOME.......................................................................................... 1
2.1
Analytical Procedures..................................................................................... 1
2.2
Acceptance Criteria ........................................................................................ 1
3.
IMPLEMENTATION ................................................
TIMING OF ANNEX IMPLEMENTATION ................................................ 1
4.
IMPLEMENTATION ........................................
CONSIDERATIONS FOR IMPLEMENTATION ........................................ 1
4.1
General Consideration.................................................................................... 1
4.2
FDA Consideration ......................................................................................... 2
4.3
EU Consideration ........................................................................................... 2
4.4
MHLW Consideration..................................................................................... 2
4.4
Health Canada Consideration........................................................................ 2
5.
REFERENCES USED FOR THE Q4B EVALUATION ............................... 2
i
4.
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HARMACOPOEIAL
EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR
USE IN THE ICH REGIONS
ON
DISINTEGRATION TEST GENERAL CHAPTER
Q4B ANNEX 5(R1)
1.
INTRODUCTION
This annex is the result of the Q4B process for Disintegration Test General Chapter.
The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
2.
Q4B OUTCOME
2.1
Analytical Procedures
The ICH Steering Committee, based on the evaluation by the Q4B Expert Working
Group (EWG), recommends that for tablets and capsules, the official pharmacopoeial
texts, Ph. Eur. 2.9.1. Disintegration of Tablets and Capsules, JP 6.09 Disintegration
Test, and USP <701> Disintegration, can be used as interchangeable in the ICH
regions subject to the conditions detailed below. Testing conditions for specific dosage
forms are outside the scope of the harmonization of this chapter.
2.1.1
2.1.2
The Disintegration Test is not considered to be interchangeable in the
three regions for dosage forms referred to in the regional compendia as
delayed-release, gastro-resistant, or enteric-coated.
2.1.3
2.2
For tablets and capsules larger than 18 millimeters (mm) long for which
a different apparatus is used, the Disintegration Test is not considered
to be interchangeable in the three regions.
Product-specific parameters such as media and the use of discs should
be specified in the application dossier.
Acceptance Criteria
Acceptance criteria are outside the scope of the harmonization of this chapter and
should be specified in the application dossier.
3.
IMPLEMENTATION
TIMING OF ANNEX IMPLEMENTATION
When this annex is implemented (incorporated into the regulatory process at ICH
Step 5) in a region, it can be used in that region. Timing might differ for each region.
4.
IMPLEMENTATION
CONSIDERATIONS FOR IMPLEMENTATION
4.1
General Consideration
When sponsors or manufacturers change their existing methods to the implemented
Q4B-evaluated pharmacopoeial texts that are referenced in Section 2.1 of this annex,
any change notification, variation, and/or prior approval procedures should be
1
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handled in accordance with established regional regulatory mechanisms pertaining to
compendial changes.
4.2
FDA
FDA Consideration
Based on the recommendation above, and with reference to the conditions set forth in
this annex, the pharmacopoeial texts referenced in Section 2.1 of this annex can be
considered interchangeable.
However, FDA might request that a company
demonstrate that the chosen method is acceptable and suitable for a specific material
or product, irrespective of the origin of the method.
4.3
EU Consideration
For the European Union, the monographs of the Ph. Eur. have mandatory
applicability. Regulatory authorities can accept the reference in a marketing
authorisation application, renewal or variation application citing the use of the
corresponding text from another pharmacopoeia as referenced in Section 2.1, in
accordance with the conditions set out in this annex, as fulfilling the requirements for
compliance with the Ph. Eur. Chapter 2.9.1. on the basis of the declaration of
interchangeability made above.
4.4
MHLW Consideration
The pharmacopoeial texts referenced in Section 2.1 of this annex can be used as
interchangeable in accordance with the conditions set out in this annex. Details of
implementation requirements will be provided in the notification by MHLW when this
annex is implemented.
4.5
Health Canada Consideration
In Canada, any of the pharmacopoeial texts cited in section 2.1 of this annex and used
in accordance with the conditions set out in this annex can be considered
interchangeable.
5.
5.1
EVALUATION
REFERENCES USED FOR THE Q4B EVALUATION
The PDG Stage 5B sign-off document (Rev. 1): Japanese Pharmacopoeial
Forum, Volume 16, number 4 (December 2007).
5.2
The pharmacopoeial references for Disintegration Test General Chapter for
this annex are:
5.2.1 European Pharmacopoeia (Ph. Eur.): Supplement 6.3 (official January
2009) Disintegration of Tablets and Capsules (reference 01/2009: 20901);
5.2.2 Japanese Pharmacopoeia (JP): 6.09 Disintegration Test as it appeared in
the partial revision of the JP 15th edition made official March 31, 2009,
by the Ministry of Health, Labour and Welfare Ministerial Notification
No. 190;
5.2.3 United States Pharmacopeia (USP): Revision Bulletin
Disintegration issued June 6, 2008, and official August 1, 2008.
2
<701>