This document summarizes the evaluation and recommendation of pharmacopoeial texts for the test of extractable volume of parenteral preparations general chapter from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). It recommends that the procedures and acceptance criteria from the European, Japanese, and United States pharmacopoeias can be used interchangeably. It provides guidance on implementation of this recommendation in ICH regions and considerations for sponsors changing methods.
Overcoming the stress of non-prescription medicine application screening - Co...TGA Australia
This presentation will describe how the TGA undertakes the screening process and will discuss the mandatory requirements for applications, including specific examples of problems commonly encountered.
Watch the webinar here: https://bit.ly/2lLquKk
Since 2017 Chinese Health Authority has published new regulation for Co-Review procedure of API, excipient and packaging material. Focusing on the unique regulatory requirement for registration of excipient we will give you an overview about the dossier requirement, ChP compliance and impact for the pharmaceutical industry.
If you want to market your drug into China, are you aware that excipient used in your drug need to be registered and to be compliance wtih Chinese pharmacopoeia? Since 2017 Chinese Health Authority has published new regulation for Co-Review procedure of API, excipient and packaging material. Focusing on the unique regulatory requirement for registration of excipient we will give you an overview about the dossier requirement, ChP compliance and impact for the pharmaceutcal industry.
In this webinar, you will learn:
- Current Chinese regulation for excipient registration
- Chinese pharmacopoeia as standard for the excipients
- Impact of excipient regulation for pharmaceutical industries
Watch the webinar here: https://bit.ly/2lLquKk
Since 2017 Chinese Health Authority has published new regulation for Co-Review procedure of API, excipient and packaging material. Focusing on the unique regulatory requirement for registration of excipient we will give you an overview about the dossier requirement, ChP compliance and impact for the pharmaceutical industry.
If you want to market your drug into China, are you aware that excipient used in your drug need to be registered and to be compliance wtih Chinese pharmacopoeia? Since 2017 Chinese Health Authority has published new regulation for Co-Review procedure of API, excipient and packaging material. Focusing on the unique regulatory requirement for registration of excipient we will give you an overview about the dossier requirement, ChP compliance and impact for the pharmaceutcal industry.
In this webinar, you will learn:
- Current Chinese regulation for excipient registration
- Chinese pharmacopoeia as standard for the excipients
- Impact of excipient regulation for pharmaceutical industries
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.
EU and US Procedures for API Registration - Commonalities and DifferencesMerck Life Sciences
View the interactive recording here: https://bit.ly/2PB0VZo
Abstract:
This webinar will review the current requirements for the active substance registration in the European Union and the USA. First, we will summarize the authority regulations for APIs in the EU and USA and show the similarities and differences of procedures such as CEP, AMSF, and US-DMF. Secondly, we’ll cover new trends and requirements for API-dossiers such as the control of elemental impurities according to the new international guideline ICH Q3D and related watchouts for CEPs. At the end of the presentation, we’ll discuss the eCTD roadmap for the future and the end of paper submissions.
common technical document vs electronic common technical document MayankGupta851
This presentation deals with brief overview of common technical document and its electronic version that is implemented by three ICH regions and common format for the dossier preparation for NDA application and documents required to prepare types of modules in database in specified format as specified by regulatory authorities.
Overcoming the stress of non-prescription medicine application screening - Co...TGA Australia
This presentation will describe how the TGA undertakes the screening process and will discuss the mandatory requirements for applications, including specific examples of problems commonly encountered.
Watch the webinar here: https://bit.ly/2lLquKk
Since 2017 Chinese Health Authority has published new regulation for Co-Review procedure of API, excipient and packaging material. Focusing on the unique regulatory requirement for registration of excipient we will give you an overview about the dossier requirement, ChP compliance and impact for the pharmaceutical industry.
If you want to market your drug into China, are you aware that excipient used in your drug need to be registered and to be compliance wtih Chinese pharmacopoeia? Since 2017 Chinese Health Authority has published new regulation for Co-Review procedure of API, excipient and packaging material. Focusing on the unique regulatory requirement for registration of excipient we will give you an overview about the dossier requirement, ChP compliance and impact for the pharmaceutcal industry.
In this webinar, you will learn:
- Current Chinese regulation for excipient registration
- Chinese pharmacopoeia as standard for the excipients
- Impact of excipient regulation for pharmaceutical industries
Watch the webinar here: https://bit.ly/2lLquKk
Since 2017 Chinese Health Authority has published new regulation for Co-Review procedure of API, excipient and packaging material. Focusing on the unique regulatory requirement for registration of excipient we will give you an overview about the dossier requirement, ChP compliance and impact for the pharmaceutical industry.
If you want to market your drug into China, are you aware that excipient used in your drug need to be registered and to be compliance wtih Chinese pharmacopoeia? Since 2017 Chinese Health Authority has published new regulation for Co-Review procedure of API, excipient and packaging material. Focusing on the unique regulatory requirement for registration of excipient we will give you an overview about the dossier requirement, ChP compliance and impact for the pharmaceutcal industry.
In this webinar, you will learn:
- Current Chinese regulation for excipient registration
- Chinese pharmacopoeia as standard for the excipients
- Impact of excipient regulation for pharmaceutical industries
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.
EU and US Procedures for API Registration - Commonalities and DifferencesMerck Life Sciences
View the interactive recording here: https://bit.ly/2PB0VZo
Abstract:
This webinar will review the current requirements for the active substance registration in the European Union and the USA. First, we will summarize the authority regulations for APIs in the EU and USA and show the similarities and differences of procedures such as CEP, AMSF, and US-DMF. Secondly, we’ll cover new trends and requirements for API-dossiers such as the control of elemental impurities according to the new international guideline ICH Q3D and related watchouts for CEPs. At the end of the presentation, we’ll discuss the eCTD roadmap for the future and the end of paper submissions.
common technical document vs electronic common technical document MayankGupta851
This presentation deals with brief overview of common technical document and its electronic version that is implemented by three ICH regions and common format for the dossier preparation for NDA application and documents required to prepare types of modules in database in specified format as specified by regulatory authorities.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
EU and US Procedures for API Registration - Commonalities and DifferencesMilliporeSigma
View the interactive recording here: https://bit.ly/2PB0VZo
Abstract:
This webinar will review the current requirements for the active substance registration in the European Union and the USA. First, we will summarize the authority regulations for APIs in the EU and USA and show the similarities and differences of procedures such as CEP, AMSF, and US-DMF. Secondly, we’ll cover new trends and requirements for API-dossiers such as the control of elemental impurities according to the new international guideline ICH Q3D and related watchouts for CEPs. At the end of the presentation, we’ll discuss the eCTD roadmap for the future and the end of paper submissions.
The Circular 11/2018/TT-BYT provides for application of quality standards of drugs (modern drugs, herbal drugs, vaccines and biological) and drug ingredients (except herbal ones); drug/drug ingredient tests and procedures for recall and handling of unconformable drugs.
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.
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.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
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
By Dr. Vinod Kumar Kanvaria
Delivering Micro-Credentials in Technical and Vocational Education and TrainingAG2 Design
Explore how micro-credentials are transforming Technical and Vocational Education and Training (TVET) with this comprehensive slide deck. Discover what micro-credentials are, their importance in TVET, the advantages they offer, and the insights from industry experts. Additionally, learn about the top software applications available for creating and managing micro-credentials. This presentation also includes valuable resources and a discussion on the future of these specialised certifications.
For more detailed information on delivering micro-credentials in TVET, visit this https://tvettrainer.com/delivering-micro-credentials-in-tvet/
A workshop hosted by the South African Journal of Science aimed at postgraduate students and early career researchers with little or no experience in writing and publishing journal articles.
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!
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
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.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
1. Get All Pharmaceutical Guidelines on www.pharmaguideline.com Email- info@pharmaguideline.com
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
XTRACTABLE
TEST FOR EXTRACTABLE VOLUME OF PARENTERAL
PREPARATIONS GENERAL CHAPTER
Q4B ANNEX 2(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.
2. Get All Pharmaceutical Guidelines on www.pharmaguideline.com Email- info@pharmaguideline.com
Q4B Annex 2(R1)
Document History
Code
History
Q4B Annex 2
Approval by the Steering Committee under Step 2 and
release for public consultation.
Q4B Annex 2
Approval by the Steering Committee under Step 4 and
recommendation for adoption to the three ICH regulatory
bodies.
Date
1 November
2007
5 June
2008
Step
Current Step 4 version
Q4B Annex 2(R1) Integration of the Health Canada Interchangeability
Statement under Section 4 after approval by the Steering
Committee.
27 September
2010
3. Get All Pharmaceutical Guidelines on www.pharmaguideline.com Email- info@pharmaguideline.com
EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS
FOR USE IN THE ICH REGIONS
ON
TEST FOR EXTRACTABLE VOLUME OF PARENTERAL PREPARATIONS
GENERAL CHAPTER
ICH Harmonised Tripartite Guideline
Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting
on 5 June 2008, 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.................................................................................................. 1
NTRODUCTION..................................................................................................
................................................................................................
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
5.
.........................................
REFERENCES USED FOR THE Q4B EVALUATION ......................................... 2
i
4.
5. Get All Pharmaceutical Guidelines on www.pharmaguideline.com Email- info@pharmaguideline.com
EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS
FOR USE IN THE ICH REGIONS
ON
TEST FOR EXTRACTABLE VOLUME OF PARENTERAL PREPARATIONS
GENERAL CHAPTER
1.
INTRODUCTION
This annex is the result of the Q4B process for the Test for Extractable Volume of
Parenteral Preparations General Chapter. The proposed texts were submitted by the
Pharmacopoeial Discussion Group (PDG).
2.
Q4B OUTCOME
2.1
Procedures
Analytical Procedures
The ICH Steering Committee, based on the evaluation by the Q4B Expert Working
Group (EWG), recommends that the official pharmacopoeial texts, Ph.Eur. 2.9.17.
Test for Extractable Volume of Parenteral Preparations, JP 6.05 Test for Extractable
Volume of Parenteral Preparations, and the section in USP <1> Injections General
Chapter entitled "Volume in Containers” can be used as interchangeable in the ICH
regions.
2.2
Acceptance Criteria
The acceptance criteria are the same in the three pharmacopoeias.
3.
TIMING OF ANNEX IMPLEMENTATION
When this annex has been 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.
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 handled in accordance with
established regional regulatory mechanisms pertaining to compendial changes.
4.2
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
1
6. Get All Pharmaceutical Guidelines on www.pharmaguideline.com Email- info@pharmaguideline.com
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,
Test for Extractable Volume of Parenteral Preparations: 2.9.17., 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
In Canada, any of the 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.
REFERENCES USED FOR THE Q4B EVALUATION
5.1
The PDG Stage 5B sign-off document: Japanese Pharmacopoeial Forum,
Volume 13, Number 3 (August 2004).
5.2
The pharmacopoeial references for Test for Extractable Volume of Parenteral
Preparations:
5.2.1
European Pharmacopoeia (Ph. Eur.):
5.2.2
Japanese Pharmacopoeia (JP): 6.05 Test for Extractable Volume of
Parenteral Preparations as it appears in the JP Fifteenth Edition
(March 31, 2006, The Ministry of Health, Labour and Welfare
Ministerial Notification No. 285);
5.2.3
United States Pharmacopeia (USP): official text published in the
Supplement 5.3 (official on
January 2006), Test for Extractable Volume of Parenteral Preparations
(reference 01/2006:20917);
Revision Bulletin issued November 14, 2006, and as appeared in USP
30, 2nd Supplement, official December 1, 2007. The official text is
incorporated in <1> Injections General Chapter as the section entitled
"Volume in Containers".
2