This document provides an overview of industry and FDA liaison as well as ICH-Q guidelines. It discusses the roles and responsibilities of the FDA, including inspections, legal actions, and scientific review. It also describes the organization of the FDA and initiatives to expedite drug approval. Finally, it introduces ICH as an international harmonization effort and outlines the various ICH working groups and Q guidelines related to quality, safety, efficacy and other topics.
CMC, post approval regulatory affairs, etcJayeshRajput7
this document covers points such as CMC, post approval regulatory affairs, regulation for combination products, and medical devices, common technical document (CTD) and electronic common technical document (eCTD) format, industry and FDA liasion, ICH guidelines of ICH Q,S,E,M, regulatory requirements of EU, MHRA, TGA and ROW countries.
Investigational medical product dossierSachinFartade
Investigational medical product dossier is document made to apply for clinical trial application in European Union. European Medical Agency is regulatory body for drug approval in European Union.
CMC, post approval regulatory affairs, etcJayeshRajput7
this document covers points such as CMC, post approval regulatory affairs, regulation for combination products, and medical devices, common technical document (CTD) and electronic common technical document (eCTD) format, industry and FDA liasion, ICH guidelines of ICH Q,S,E,M, regulatory requirements of EU, MHRA, TGA and ROW countries.
Investigational medical product dossierSachinFartade
Investigational medical product dossier is document made to apply for clinical trial application in European Union. European Medical Agency is regulatory body for drug approval in European Union.
Regulatory authorities (US-FDA, WHO and ICH)Sagar Savale
To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.
With respect to such products, protect the public health by ensuring that the food are safe, Wholesome, sanitary, and properly labelled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labelled, and public health and safety are protected from the electronic product radiation.
Participates through appropriate process with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.
Pharmacovigilance Interview Question Part 1ClinosolIndia
"Pharmacovigilance Interview Question Part 1." In this insightful presentation, we delve into the crucial world of pharmacovigilance, exploring fundamental concepts and key questions that play a pivotal role in ensuring drug safety and healthcare integrity.
Embarking on a journey into the intricate realm of drug safety, 'Exploring the Foundations of Pharmacovigilance: Part 1' lays the groundwork for a comprehensive understanding of this crucial field. This segment serves as a gateway to the fundamental principles that underpin pharmacovigilance, unraveling the intricacies of adverse drug reaction monitoring and reporting. Delving into the significance of pharmacovigilance in ensuring patient safety, the exploration encompasses the key concepts and processes that form the backbone of drug safety surveillance. From identifying adverse events to understanding the roles of healthcare professionals and regulatory bodies, 'Part 1' provides a solid foundation for both novices and seasoned professionals alike. As we navigate through this informative chapter, the importance of robust pharmacovigilance practices in the ever-evolving landscape of healthcare becomes increasingly evident, setting the stage for the advanced concepts and global perspectives to follow in subsequent parts of this insightful series.
Medicines and Healthcare products Regulatory Agency(MHRA)TMU
What are regulatory bodies:- In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing. marketing and labeling of pharmaceutical products like:
USFDA(USA)
MHRA(UK)
TGA(Australia
AIMS:- Protecting public health through regulation, with acceptablebenefit-risk profiles for medicines and devices.
Promoting public health by helping people who use these productsto understand their benefits and risks.
Improving public health by encouraging and facilitating developments in products that will benefit people
GUIDELINES:- Guidelines for Manufacturers on Clinical Investigations to be carried out in the UK.
Inspected UK Contract GMP Quality Control Laboratories.
BLUE GUIDE: Advertising and Promotion of medicines in the UK.
ORANGE GUIDE: Rules and Guidelines for Pharmaceutical Manufacturers and Distributors.
Good Pharmacovigilance Practice Guide.
Guidelines on Process Validation
Guide to UK GLP Regulations 1999
Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products.
Guide to defective medicinal products.
Introduction of a Risk Based Inspection Programme for GMP Labs.
SALIENT FEATURES, COMMITTEES/WORKING GROUPS:-
MHRA has the power to withdraw a product from market and suspend production of medicines.
A manufacturer or distributor can be prosecuted if the law has been broken.
Regulatory decisions are impartial D Different products are treated differently.
MHRA collaborates with :
US Food and Drug Administration
NPSA National Patient Safety Agency
NICE National Institute for Health and Clinical Excellence
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...GL Anaacs
Contact us if you are interested:
Email / Skype : kefaya1771@gmail.com
Threema: PXHY5PDH
New BATCH Ku !!! MUCH IN DEMAND FAST SALE EVERY BATCH HAPPY GOOD EFFECT BIG BATCH !
Contact me on Threema or skype to start big business!!
Hot-sale products:
NEW HOT EUTYLONE WHITE CRYSTAL!!
5cl-adba precursor (semi finished )
5cl-adba raw materials
ADBB precursor (semi finished )
ADBB raw materials
APVP powder
5fadb/4f-adb
Jwh018 / Jwh210
Eutylone crystal
Protonitazene (hydrochloride) CAS: 119276-01-6
Flubrotizolam CAS: 57801-95-3
Metonitazene CAS: 14680-51-4
Payment terms: Western Union,MoneyGram,Bitcoin or USDT.
Deliver Time: Usually 7-15days
Shipping method: FedEx, TNT, DHL,UPS etc.Our deliveries are 100% safe, fast, reliable and discreet.
Samples will be sent for your evaluation!If you are interested in, please contact me, let's talk details.
We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
1. INDUSTRY AND FDA LIAISON &
ICH – Q GUIDELINES
K. Bhanu Sri Chandana
2020MPH40A023
M. PHARMACY
Dept. of Pharmaceutics
Under the guidance of
Dr. K. Sai Sruthi
M. Pharmacy, Ph. D
2. FDA and Industrial Liaison
FDA and its responsibilities
Missions of FDA
FDA Organizations and contacts
FDA initiatives for speed drug approval
ICH
Introduction to ICH
Working groups of ICH
ICH – Q guidelines
References
CONTENTS
4. Introduction
Liaison means Communication or Co-operation.
Every Pharmaceutical industry must follow some of the regulations held by its
higher authorities.
FDA also lays some of the regulations in order to maintain the quality and safety of
drugs and pharmaceutical products.
Effective communication should be maintained between Pharmaceutical Industries
and FDA .
5. Food and Drug Administration
FDA is one of the United States oldest consumer protection agencies.
It is a federal agency of the Department of Health and Human Services,
formed on June 30, 1906.
Its Headquarters is the White Oak Campus which is located at Maryland.
It is led by the ‘Commissioner of Food and Drugs’ who as appointed by the
President along with the consent of the Senate.
Currently, Janet Wood Cook is acting as the commissioner of FDA since
January 20, 2021.
FDA is charged with protecting American consumers by enforcing the
Federal Food, Drug and Cosmetic Act and some of the public related health
laws and has 223 field offices and 13 laboratories located throughout 50 states.
6. Responsibilities of FDA
FDA is responsible for protecting and promoting public health through
control and supervision of the following categories :
Food safety and Dietary supplements
Animal foods and feeds
Tobacco products
Prescription and other OTC drugs
Vaccines and Biopharmaceuticals
Blood transfusions
Medical devices
Cosmetics
Veterinary products
7. Missions of FDA
1. Inspections and legal sanctions
2. Scientific expertise
3. Product safety
To ensure the safety and effectiveness of the products
under its jurisdiction, FDA sets the following missions:
8. 1. Inspections and Legal sanctions
The investigators and inspectors visit more than 16,000 facilities a year,
for ensuring the product safety and label truthfulness.
As a part of investigation, FDA scientists collect about 80,000 domestic
and imported samples for the examination of label checks.
Any company found violating the laws, FDA suggests to correct the
problem voluntarily or asks to recall the product from the market.
If the company does not obey FDA, it has all the rights to enforce legal
actions and proceed to the court to stop the product selling.
Criminal penalties and prison sentences can be imposed against
manufacturers and distributors.
9. 2. Scientific expertise
Scientific evidence needed for filing a case against any
company can be prepared by nearly 2,100 scientists including
900 chemists and 300 microbiologists.
Among all these scientists, some look after analyzing samples
and others review the test results which are submitted by the
companies seeking approval for drugs, vaccines, food
additives, coloring agents.
This agency determines the benefits of the new drug products
over its side effects.
10. 3. Product Safety
To protect the safety and wholesomeness of product, the
samples are tested for any pesticidal residues that are
unacceptable.
If contaminants are identified, FDA takes corrective action
and also sets labelling standards for consumers knowledge.
FDA is also responsible for nations blood supply.
Investigators routinely examine the blood banks and records
the contaminants
FDA ensures the purity and effectiveness of cosmetics,
medical devices vaccines and insulin.
11. FDA’s Organizations
National Center for Toxicological Research Center for Food Safety and Applied Nutrition
Center for Tobacco Products Center for Veterinary Medicine Office of Women’s Health
12. Center for Biologics Evaluation and
Research
Office of Regulatory Affairs
Office of International Programes
Center for Drug Evaluation and Research
Center for Devices and
Radiological Health
13. Center Area of Responsibility
Center for Drug Evaluation and Research Safety and effectiveness of Prescription and OTC drugs
Center for Biologics Evaluation and Research Safety and effectiveness of vaccines, nation’s blood
supply, Biologics
Center for Devices and Radiological Health Safety and effectiveness of Medical devices, diagnostic
tests, Radiation emitting devices
Center for Food Safety and Applied Nutrition Safety of domestic and imported food supply, cosmetics
and dietary supplements
Center for Veterinary Medicine Safety and effectiveness of veterinary drugs
Center for Tobacco Products Implementation of the Family Smoking Prevention and
Tobacco Control Act
National Center for Toxicological Research Research to support regulatory decisions and reduce risks
associated with FDA regulated products
Office of Regulatory Affairs Enforcement of Laws and regulations
Table
14. FDA initiatives to speed drug approval
Subpart E in Section 312 of the Code of Federal
Regulations, FDA establishes some procedures to speedup the process
of development, evaluation, and marketing of new therapies to treat
people with life-threatening and severely debilitating illnesses,
especially where no satisfactory alternatives exist.
A. Accelerated development or Review Program
B. Treatment IND
C. FDA guidelines
16. ICH
International Council for Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH)
It is a joint initiative involving both the regulatory authorities and research based
pharmaceutical industries of the European Union, Japan and the United states.
It is an international non-profitable association that involves the scientific and technical
discussions of the testing procedures required to assess and ensure the safety, quality,
efficacy and other multidisciplinary activities of medicines.
ICH is formed in April 1990, with an objective of coordinating the regulatory authorities
and pharmaceutical industries for better harmonisation.
17. Mission
Harmonisation for Better Health
ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and
high quality medicines are developed and registered in the most resource-efficient manner.
Harmonisation is achieved through the development of ICH Guidelines via a process of scientific
consensus with regulatory and industry experts working side-by-side.
Reason for the success of this process is the commitment of the ICH regulators to implement the final
Guidelines.
ICH is an international non-profit Association which is under Swiss law on October 23, 2015.
19. Auditors
The Auditors are responsible to audit the financial statements of the Association upon conclusion of
each Fiscal Year.
They should ensure that the accounting of the Association complies with Swiss law and generally
accepted Swiss accounting principles.
The Auditors are appointed for a period of two years
20. Assembly
The ICH Assembly brings together all Members and Observers of the ICH Association as the
overarching governing body of ICH.
It makes decisions on matters such as on the Articles of Association, admission of new Members
& Observers and adoption of ICH Guidelines.
The Assembly meets biannually and the reports are made available on the ICH website
summarizing the main decisions taken at each meeting
21. Members
1. European Union (EU)
2. European Federation of Pharmaceutical Industries and Associations (EFPIA)
3. Ministry of Health , Labour and Welfare (MHLW)
4. Japan Pharmaceutical Manufacturers Association (JPMA)
5. Food and Drug Administration (FDA)
6. Pharmaceutical Research and Manufacturers of America (PhRMA)
Observers
1. World Health Organization (WHO)
2. International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
22. Management Committee
The ICH Management Committee (MC) is the body that oversees operational aspects of ICH on behalf of
all Members, including administrative and financial matters and oversight of the Working Groups (WGs).
The MC is responsible for submitting recommendations or proposals to the Assembly in preparation of
Assembly discussions.
MedDRA Management Committee
The MedDRA Management Committee (MC) has responsibility for direction of MedDRA.
It is a ICH standardised dictionary of medical terminology.
The MedDRA MC is composed of the EC, EFPIA - Europe; ; MHLW, JPMA - Japan; ; FDA, PhRMA -
United States; Health Canada - Canada; and WHO
24. Quality Guidelines
Harmonisation achievements in the Quality area includes the
conduct of stability studies, defining relevant thresholds for impurities
testing and a more flexible approach to pharmaceutical quality based on
Good Manufacturing Practice (GMP) risk management.
Safety Guidelines
ICH has produced a comprehensive set of safety Guidelines to
uncover potential risks like carcinogenicity and genotoxicity.
25. Efficacy Guidelines
The work carried out by ICH under the Efficacy is concerned with the
design, conduct, safety and reporting of clinical trials. It also covers novel
types of medicines derived from biotechnological processes and the use of
pharmacogenetics/genomics techniques to produce better targeted medicines.
Multidisciplinary Guidelines
These are the cross-cutting topics which do not fit uniquely into one of the
Quality, Safety and Efficacy categories. It includes the ICH medical terminology
(MedDRA), the Common Technical Document (CTD) and the development of
Electronic Standards for the Transfer of Regulatory Information (ESTRI)
27. Q1A – Q1F Stability
Q2 Analytical Validation
Q3A – Q3E Impurities
Q4A – Q4B Pharmacopoeias
Q5A – Q5E Biotechnological Products
Q6A – Q6B Specifications
Q7 Good Manufacturing Practices
Q8 Pharmaceutical Development
Q9 Quality Risk Management
Q10 Pharmaceutical Quality System
Q11 Development and Manufacture of drug substances
Q12 Lifecycle Management
Q13 Continuous Manufacture of drug substances and Drug Products
28. Sub – parts of ICH – Q Guidelines
Q1A (R2) - Stability Testing of New Drug Substances and Products
This guideline provides recommendations on stability testing protocols including temperature, humidity
and trail duration for different climatic zones in order to minimize the difference storage conditions for
global submission.
Q1B - Stability Testing : Photostability Testing of New Drug Substances and Products
This Guideline gives basic testing protocols required to evaluate the light sensitivity and stability of
new drugs and products.
Q1C - Stability Testing For New Dosage Forms
It extends the main stability guideline for new formulations of already approved medicines.
29. Q1D - Bracketing and Matrixing Designs For Stability Testing of New Drug Substances and Products
This is intended to address recommendations on the application of Bracketing and Matrixing to
stability studies.
Q1E - Evaluation of Stability Data
Q1F - Stability Data Package For registration Applications in Climatic Zones III and IV
Q2 (R1) - Validation of Analytical Procedures : Text and Methodology
Q2 (R2) - Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation
Q3A (R2) - Impurities in New Drug Substances
This guideline Addresses the chemistry and safety aspects of impurities and identification and
qualification of the drug products
30. Q3B (R2) - Impurities in New Drug Products
• This guideline focuses on impurities in new drug substances and provides advice in regard to impurities in
products containing new, chemically synthesized drug substances .
• It deals with the impurities that arises by degradations, interactions between drug substance and excipients.
Q3C (R8) - Maintenance of The Guideline For Residual Solvents
• It provides recommendations on the use of less toxic solvents in the manufacture of drug substances and dosage
forms.
• It sets the pharmaceutical limits for residual solvents in drug products.
Q3D (R1) - Guidelines for Elemental Impurities
• This guideline is implemented for the control of elemental impurities in new drug products
31. Q3D (R2) - Revision of Q3D (R1) cutaneous and transdermal products
Q3D Training - Implementation of Guideline For Elemental Impurities
Q3E - Impurity : Assessment and Control of Extractables and Leachables For Pharmaceutical and Biologics
Q4A - Pharmacopoeial Harmonisation
• The pharmacopoeial authorities works together through the Pharmacopoeial Discussion Group
Q4B - Evaluation and Recommendation of Pharmacopoeial Texts for Use in The ICH Regions
Q5A - Viral Safety Evaluation of Biotechnology Products Derived form Cell Lines of Human or Animal Origin
Q5B - Analysis of The Expression Construct in cells Used for Production of r - DNA Derived Protein Products
This document is intended to describe the types of information that are considered valuable in assessing the
structure of expression construct used to produce r - DNA derived proteins
32. Q5C - Quality of Biotechnological Products : Stability Testing of Biological Products
• This document augments the stability Guideline (Q1A) and deals with the particular aspects of stability
test procedures needed to take account of the special characteristics of products in which the active
components are typically proteins and/or polypeptides.
Q5D - Derivation and Characterization of Cell Substrates Used for Production of Biological Products
• This document provides broad guidance on appropriate standards for the derivation of human and animal
cell lines and microbial cells used to prepare biotechnological/biological products, and for the preparation
and characterization of cell banks to be used for production.
Q5E - Comparability of Biological Products Subject to Changes in their Manufacturing Process
• The objective of this document is to provide principles for assessing the comparability of
biotechnological/biological products before and after changes are made in the manufacturing process for
the drug substance or drug product.
33. Q6A - Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products
• This document provides guidance on the setting and justification of acceptance criteria and the selection of
test procedures for new drug substances of synthetic chemical origin, and new drug products produced
from them, which have not been registered previously in the ICH regions.
Q6B - Specifications : Test Procedures and Acceptance Criteria for Biological Products
• This document provides general principles on the setting and justification of a uniform set of international
specifications for proteins and polypeptides which are produced from recombinant or non-recombinant
cell-culture expression systems.
Q7 - Good Manufacturing practice for active Pharmaceutical Ingredients
• This document is intended to provide guidance regarding Good Manufacturing Practice (GMP) for the
manufacturing of Active Pharmaceutical Ingredients (APIs) under an appropriate system for managing
quality.
34. • It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport
or are represented to possess.
• This Guideline applies to the manufacture of APIs for use in human drug (medicinal) products.
• It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being
rendered sterile.
• The sterilization and aseptic processing of sterile APIs are not covered by this guidance, but should be
performed in accordance with GMP guidelines for drug (medicinal) products as defined by local
authorities.
35. Q8 (R2) - Pharmaceutical Development
• This Guideline is intended to provide guidance on the contents for drug products as defined the Common
Technical Document
Q9 - Quality Risk Management
• This Guideline provides principles and examples of tools for quality risk management that can be applied
to different aspects of pharmaceutical quality.
• These aspects include development, manufacturing, distribution, and the inspection and
submission/review processes throughout the lifecycle of drug substances, drug products, biological and
biotechnological products.
Q10 - Pharmaceutical Quality System
• This Guideline applies to the systems supporting the development and manufacture of pharmaceutical drug
substances and drug products, including biotechnology and biological products, throughout the product
lifecycle.
36. Q11 - Development and Manufacture of Drug Substances
Q12 - Technical and Regulatory considerations for Pharmaceutical Product Lifecycle Management
• This new Guideline is proposed to provide a framework to facilitate the management of post-approval
Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across
the product lifecycle.
Q13 - Continuous Manufacturing of Drug substances and Drug Products
• Capture key technical and regulatory considerations that promote harmonisation, including certain Current
Good Manufacturing Practices (CGMP) elements specific to Continuous Manufacturing (CM),
• Allow drug manufacturers to employ flexible approaches to develop, implement, or integrate CM for the
Manufacture – drug substances and drug products – of small molecules and therapeutic proteins for new and
existing products.
37. Q14 – Analytical procedure Development and Revision of Q2 (R1) Analytical Validation
• This new guideline is proposed to harmonise the scientific approaches of Analytical Procedure
Development, and to provide the principles relating to the description of Analytical Procedure
Development process.
• This new guideline is intended to improve regulatory communication between industry and regulators
and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change
management of analytical procedures.
38. References
New Drug Approval Process – Fourth edition Accelerating Global
Regulations, Edited by Richard A. Guarino, M.D.
www.fda.gov
www.ich.org