ICH is stand for the “International Conference on Harmonization of Technical Requirement for Pharmaceuticals for Human Use”
Goal of ICH. ICH Guidelines.
Q (Quality) S (Safety)
Related to chemical & pharmaceutical Quality Assurance ( Stability Testing, Impurity Testing etc.)
Related to in vitro & in vivo pre-clinical studies (Carcinogenicity Testing, genotoxicity Testing, etc.)
Stability testing of new drug substances and products.
Validation of Analytical Procedures : Text & Methodology
Regulatory Acceptance of Analytical Procedure &Acceptance Criteria (RAAPAC)
Carcinogenicity Studies (S1A-S1C)
optimization techniques in pharmaceutical product developmentDeepthiKolluru1
optimization techniques and factorial designs in pharmaceutical product development.its examples in pharmaceutics and formulation for both b.pharm, m.pharm and pharm.d students
In this presentation I have mentioned whatever the possible relevant content/guidelines require for biowaiver application.
Citation Is done at the end of slide.
Content is up to date & true to my belief.
Thanks & Best Regards.
Anurag Pandey
B.Pharm (FACULTY OF PHARMACY, INVERTIS UNIVERSITY)
M.Pharm (INSTITUTE OF PHARMACY, NIRMA UNIVERSITY)
Email :- anurag.dmk05@gmail.com
optimization techniques in pharmaceutical product developmentDeepthiKolluru1
optimization techniques and factorial designs in pharmaceutical product development.its examples in pharmaceutics and formulation for both b.pharm, m.pharm and pharm.d students
In this presentation I have mentioned whatever the possible relevant content/guidelines require for biowaiver application.
Citation Is done at the end of slide.
Content is up to date & true to my belief.
Thanks & Best Regards.
Anurag Pandey
B.Pharm (FACULTY OF PHARMACY, INVERTIS UNIVERSITY)
M.Pharm (INSTITUTE OF PHARMACY, NIRMA UNIVERSITY)
Email :- anurag.dmk05@gmail.com
Monoclonal Antibodies as drug delivery systemNithin Kurian
in current scenario apart of traditional route of drug administration monoclonal antibodies can be used which are proved to be more effective in many cases.
It is defined as “the predictive mathematical model that describes the relationship between in vitro property (such as rate & extent of dissolution) of a dosage form and in vivo response (such as plasma drug concentration or amount of drug absorbed)”.
An in-vitro in-vivo correlation (IVIVC) has been defined by the U.S. Food and Drug Administration (FDA) as "a predictive mathematical model describing the relationship between an in-vitro property of a dosage form and an in-vivo response".
A detailed study on the guidelines that are taken for ICH which is also known as the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The chapter deals with an overview of Quality, Safety, Efficacy and Multidisciplinary guidelines and then a detailed study on the Quality Guidelines. Also a detailed learning of Stability Testing Guidelines proposed by the International Conference for Harmonization.
Vaccine- Biological preparation containing weakened or killed form of microbes that provides immunity against a particular disease.
Stimulates the body’s immune system which perceives the microbes as a threat and destroys them.
WHO report shows there are vaccines for 25 different infections.
Vaccination is responsible for the worldwide eradication of small pox and restriction of diseases as polio, measles and tetanus.
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
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.
Monoclonal Antibodies as drug delivery systemNithin Kurian
in current scenario apart of traditional route of drug administration monoclonal antibodies can be used which are proved to be more effective in many cases.
It is defined as “the predictive mathematical model that describes the relationship between in vitro property (such as rate & extent of dissolution) of a dosage form and in vivo response (such as plasma drug concentration or amount of drug absorbed)”.
An in-vitro in-vivo correlation (IVIVC) has been defined by the U.S. Food and Drug Administration (FDA) as "a predictive mathematical model describing the relationship between an in-vitro property of a dosage form and an in-vivo response".
A detailed study on the guidelines that are taken for ICH which is also known as the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The chapter deals with an overview of Quality, Safety, Efficacy and Multidisciplinary guidelines and then a detailed study on the Quality Guidelines. Also a detailed learning of Stability Testing Guidelines proposed by the International Conference for Harmonization.
Vaccine- Biological preparation containing weakened or killed form of microbes that provides immunity against a particular disease.
Stimulates the body’s immune system which perceives the microbes as a threat and destroys them.
WHO report shows there are vaccines for 25 different infections.
Vaccination is responsible for the worldwide eradication of small pox and restriction of diseases as polio, measles and tetanus.
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
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.
In this slide contains a ICH guideleine for Quality, Safety , Efficacy and Multidisciplinary
Quality
Guidelines
Safety Guidelines
Efficacy Guidelines
Multidisciplinary
Guidelines
Key importance of ICH guideline, a brief summary on the international guidelines for new drug development.
Specifically for regulatory affairs student of MPharm
Pharmacovigilance (PV) plays a crucial role in ensuring the safety of drugs and monitoring their adverse effects. During an interview for a pharmacovigilance position or a related role, you may come across questions about the uses and importance of pharmacovigilance. Here are some potential interview questions related to the uses of pharmacovigilance
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
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.
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.
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!
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
The Indian economy is classified into different sectors to simplify the analysis and understanding of economic activities. For Class 10, it's essential to grasp the sectors of the Indian economy, understand their characteristics, and recognize their importance. This guide will provide detailed notes on the Sectors of the Indian Economy Class 10, using specific long-tail keywords to enhance comprehension.
For more information, visit-www.vavaclasses.com
This is a presentation by Dada Robert in a Your Skill Boost masterclass organised by the Excellence Foundation for South Sudan (EFSS) on Saturday, the 25th and Sunday, the 26th of May 2024.
He discussed the concept of quality improvement, emphasizing its applicability to various aspects of life, including personal, project, and program improvements. He defined quality as doing the right thing at the right time in the right way to achieve the best possible results and discussed the concept of the "gap" between what we know and what we do, and how this gap represents the areas we need to improve. He explained the scientific approach to quality improvement, which involves systematic performance analysis, testing and learning, and implementing change ideas. He also highlighted the importance of client focus and a team approach to quality improvement.
Students, digital devices and success - Andreas Schleicher - 27 May 2024..pptxEduSkills OECD
Andreas Schleicher presents at the OECD webinar ‘Digital devices in schools: detrimental distraction or secret to success?’ on 27 May 2024. The presentation was based on findings from PISA 2022 results and the webinar helped launch the PISA in Focus ‘Managing screen time: How to protect and equip students against distraction’ https://www.oecd-ilibrary.org/education/managing-screen-time_7c225af4-en and the OECD Education Policy Perspective ‘Students, digital devices and success’ can be found here - https://oe.cd/il/5yV
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.
For more information, visit-www.vavaclasses.com
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
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.
TESDA TM1 REVIEWER FOR NATIONAL ASSESSMENT WRITTEN AND ORAL QUESTIONS WITH A...
ICH guidelines Q & S .pptx
1. Seminar on
ICH GUIDELINES Q & S
Presented By-:
Suryawanshi Nishinandan R.
(M Pharm 1 St
Year, Sem-I)
Dept. Of Pharmaceutics
Roll No:-5006
Guided by :-
Dr. A. V. Moholkar
Channabasweshwar Pharmacy College (degree), Latur.
2. What dose ICH stand for?
ICH is stand for the “International Conference on
Harmonization of Technical Requirement for
Pharmaceuticals for Human Use”
ICH brings together the medicines regulatory authorities
and pharmaceutical industry around the world, such as
European Union, Japan and USA in Scientific and
Technical discussion of the testing procedure required to
assess and ensure the safety, quality and efficacy of
medicines.
3. Goal of ICH
To achieve greater harmonisation worldwide for
the development and approval of safe, effective,
and high-quality medicines in the most resource-
efficient manner.
To make information available on ICH, ICH
activities and ICH guidelines to any country or
company that request the information & to
promote mutual understanding.
4. ICH Guidelines
Q (Quality) (Q1-Q11) S (Safety) (S1-S10, M3)
Related to chemical &
pharmaceutical Quality
Assurance ( Stability Testing,
Impurity Testing etc.)
Related to in vitro & in
vivo pre-clinical studies
(Carcinogenicity Testing,
genotoxicity Testing,
etc.)
6. Q6- Specification
Q7- Good Manufacturing Practice
Q8- Pharmaceutical Development
Q9- Quality Risk Management
Q10- Pharmaceutical Quality System
7. Q1(STABILLITY)(Q1A-Q1F)
Q1A (R2) - Stability testing of new drug substances
and products.
ICH Q2(R1)
Validation of Analytical Procedures : Text &
Methodology
8. ICH Q3A
Provide guidance for registration application on the content &
qualification of impurities in new drug substance produced by
chemical synthesis & not previously registered in a region state.
Impurities can be classified as the following categories :
1. Organic impurities 2. Inorganic Impurities 3. Residual solvent
9. ICHQ4B RegulatoryAcceptance ofAnalytical
Procedure &Acceptance Criteria (RAAPAC)
Effective way to raise & resolve issue that might
impact both industry & regulators.
A saving in time and Effort.
ICHQ5C Quality of Biotechnological Products :
Purpose : Guidance to applicants regarding the type
of stability studies that should provide in support of
marketing applications.
The document dosen’t cover antibiotics, allergic
extracts, heparins, vitamins, or whole blood.
10. ICHQ6A
Test Procedure & Acceptance Criteria for New Drug
Substance & New Drug Product :
It provides guidance on the setting & justification of
acceptance criteria & the selection of test procedure
for new drug substance of synthetic chemical origin ,
and new drug product produced from them, which
have not been registered previously in US, EU or
Japan.
11. ICHQ7AGuidance forActive Pharmaceutical
Ingredient :
Provide guidance regarding GMP for the
manufacturing of API under an appropriate
system for managing quality.
Distribution of APIs and related control
Vaccines are not included.
ICHQ8(R1) Pharmaceutical Development :
Defining the target product profile as it related Q, S,
& E.
Identifying Critical Quality Attributes (CQA) of the
drug product to study & control the product Quality.
Determining the Quality attributes of drug sub. &
Excipients etc. to get desired quality.
12. ICHQ9 Quality Risk Management
Describes systemic processes for the assessment,
control, communication & review of quality risk.
Applies over product lifecycle : Development,
Manufacture & Distribution.
Include principles, methodologies & examples of
tools for quality risk management.
ICHQ10 Pharmaceutical Quality System
Incorporate the concept behind Q8 & Q9 by
providing a pharmaceutical quality system that can be
implemented through out the product lifecycle.
Tract & learn product Quality
Maintain & update models as needed
Internally verify the process changes are successfully
13. ICHQ11 Development & Manufacture of Drug
Substance
High level technical guidance relevant to the
design, development & manufacture of drug
substance.
Provide guidance for drug substance (Q6A &
Q6B)
14. Carcinogenicity Studies (S1A-S1C)
S1A- Guidance on the need for carcinogenicity
studies of pharmaceuticals.
S1B- Testing foe carcinogenicity of
pharmaceuticals.
S1C(R2)- Dose selection for carcinogenicity
studies of pharmaceuticals.
S2-Genotoxicity
S2(R1)- Guidance on Genotoxicity Testing & Data
Interpretation for pharmaceutical intended for human
use.
S2A- Guidance of Specific Aspect of regulatory
Genotoxicity Tests for pharmaceuticals.
S2B- A Standard Battery for Genotoxicity Testing for
pharmaceuticals.
15. S3A-S3B Toxicokinetics & Pharmacokinetics
S3A -Note for guidance on Toxicokinetics : The
Assessment of systemic Exposure in Toxicity
Studies.
S3B- Pharmacokinetics : Guidance for Repeated
Dose Tissue Distribution Studies
S4- Duration of Chronic Toxicity Testing in
Animals ( Rodent & Non-Rodent Testing)_
S5- Detection of Toxicity to Reproduction for
Medicinal Products & Toxicity to Male Fertilits.
S6- Preclinical Safety Evaluation of
Biotechnology Derived Pharmaceuticals.
16. S7A- Safety Pharmacology Studies for Human
Pharmaceuticals
S8- Immunotoxicity Studies for Human Pharmaceuticals
S9- Nonclicinal Evaluation forAnticancer
Pharmaceuticals
S10- Guidelines-Photo Safety Evaluation of
Pharmaceuticals
S7B- Nonclinical Evaluation of the potential for delayed
ventricular repolarization (QT interval prolongation) by
human pharmaceuticals.
S11- For nonclinical safety testing in support of
development of prdiatric medicines.