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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.
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.
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.
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Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
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The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
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June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
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students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
Biological screening of herbal drugs: Introduction and Need for
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Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
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Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
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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
RESIDUE ON IGNITION/SULPHATED ASH GENERAL CHAPTER
Q4B ANNEX 1(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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1(R1)
Q4B Annex 1(R1)
Document History
Code *
History
Date
Q4B Annex 1
Approval by the Steering Committee under Step 2 and
release for public consultation.
8 June 2006
Q4B Annex 1
Approval by the Steering Committee under Step 4 and
recommendation for adoption to the three ICH regulatory
bodies.
1 November
2007
Current Step 4 version
Q4B Annex 1(R1) Integration of the Health Canada Interchangeability
Statement under Section 4.5 after approval by the
Steering Committee.
*
27 September
2010
Code as per the new codification system adopted by the ICH Steering Committee
in November 2007
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VALUATION
EVALUATION AND RECOMMENDATION OF
PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS
ON
RESIDUE ON IGNITION/SULPHATED ASH GENERAL CHAPTER
ICH Harmonised Tripartite Guideline
Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting
on 1 November 2007, 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
2.
OUTCOME................................................................................................
..........................................................................................................
Q4B OUTCOME.......................................................................................................... 1
2.1
Analytical Procedures..................................................................................................... 1
2.2
Acceptance Criteria ........................................................................................................ 1
3.
IMPLEMENTATION ................................................................
TIMING OF ANNEX IMPLEMENTATION ................................................................ 1
4.
FOR
........................................................
CONSIDERATIONS FOR IMPLEMENTATION ........................................................ 1
5.
...............................................
REFERENCES USED FOR THE Q4B EVALUATION ............................................... 2
i
4.
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EVALUATION AND RECOMMENDATION OF
PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS
ON
RESIDUE ON IGNITION/SULPHATED ASH GENERAL CHAPTER
1.
INTRODUCTION
This annex is the result of the Q4B process for Residue on Ignition/Sulphated Ash.
The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
2.
Q4B OUTCOME
Procedures
2.1
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. 20414
Sulphated Ash, JP 2.44 Residue on Ignition Test, and USP <281> Residue on Ignition
can be used as interchangeable in the ICH regions given the following:
2.1.1
Unless otherwise specified in a monograph, an appropriate sample
weight is chosen, typically 1-2 g, to result in a level of residue sufficient
to be accurately measurable by weight (typically 1 mg). If not specified
in the monograph, the appropriate sample weight should be justified,
and the sample weight and the acceptance criteria should be specified
in the application dossier.
2.1.2
The muffle furnace should be appropriately calibrated to ensure
compliance with regional GMP requirements.
2.2
Acceptance Criteria
The proposed texts evaluated did not contain acceptance criteria.
3.
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 may 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 in accordance
with 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.
1
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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,
Sulphated Ash: 20414, 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 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.
REFERENCES USED FOR THE Q4B EVALUATION
5.1
The PDG Stage 5B sign-off document:
Japanese Pharmacopoeial Forum
Volume 14, Number 4 (December 2005). (Note: the PDG cover letter
published in this volume was subsequently changed based on Q4B comments.)
5.2
The pharmacopoeial references for Residue on Ignition/Sulphated Ash for this
annex are:
5.2.1
European Pharmacopoeia (Ph. Eur.): Supplement 5.6 (official on
January 2007) (reference Sulphated Ash 01/2007:20414);
5.2.2
Japanese Pharmacopoeia (JP): 2.44 Residue on Ignition Test 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): <281> Residue on Ignition official
in USP 29, 2nd Supplement, August 2006.
2