The document outlines the key stages and requirements for drug development and approval by the FDA. It discusses the necessary chemical, manufacturing and controls (CMC) information that must be submitted at each stage, including details on the drug substance, manufacturing process, specifications, stability testing and other information for both the drug substance and drug product.
Regulatory affairs cmc , post approval regulatory affairsArjunDhawale
The document summarizes CMC (chemistry, manufacturing and controls) regulatory affairs for pharmaceutical products. It discusses the CMC section of regulatory filings which contains information on drug substance and product characteristics, manufacturing and quality. It describes the chemistry, manufacturing process, specifications and controls for ensuring consistent quality batches. It also covers CMC regulatory compliance after approval and post-approval regulatory requirements to ensure continued safety and effectiveness. The goal of CMC regulatory affairs is to provide the necessary CMC information and strategy to obtain and maintain regulatory approvals.
The document provides guidance on stability testing and data requirements for biotechnological/biological products. It recommends that stability data be provided for at least 3 batches of the drug substance manufactured at pilot scale and stored under intended conditions for 6 months or longer. For drug products, data is required from 3 batches derived from different drug substance batches, with a minimum of 6 months data if a shelf life greater than 6 months is claimed. Products should be tested regularly as per predefined protocols, with more frequent testing in early time periods. Specifications should include stability-indicating parameters to monitor purity, identity, potency and other characteristics over the proposed shelf life.
ICH Guideline Stability Testing of New Drug Substances and Product Q1A(R2).pptxTrishala Bhatt
This presentation outlines the ICH Guideline for Stability Testing of New Drug Substances and Products, Q1A(R2). It serves as a comprehensive framework for ensuring the stability of new pharmaceuticals, with a focus on the requirements for registration applications within the EC, Japan, and the United States. The guideline emphasizes a balance between a standardized approach and the flexibility to adapt to specific scientific considerations and characteristics of the materials under evaluation.
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.
This document discusses regulatory and quality assurance considerations for drug product development. It outlines that CMC development should ensure patient safety and product quality through standards like GMP. Information provided to regulators should increase in detail as development progresses from Phase 1 to Phase 3. The quality assurance function is responsible for independent assessment and oversight of manufacturing to ensure standards are met.
This document discusses regulatory and quality assurance considerations for drug product development. It outlines that CMC development should ensure patient safety and proceed simultaneously with clinical trials. Information generated at each stage of development should build upon early work and support product approval. The roles of quality assurance, quality control, and regulatory affairs are described. Guidance is provided on the type of CMC information needed for original INDs and as development progresses towards an NDA.
The document outlines the key stages and requirements for drug development and approval by the FDA. It discusses the necessary chemical, manufacturing and controls (CMC) information that must be submitted at each stage, including details on the drug substance, manufacturing process, specifications, stability testing and other information for both the drug substance and drug product.
Regulatory affairs cmc , post approval regulatory affairsArjunDhawale
The document summarizes CMC (chemistry, manufacturing and controls) regulatory affairs for pharmaceutical products. It discusses the CMC section of regulatory filings which contains information on drug substance and product characteristics, manufacturing and quality. It describes the chemistry, manufacturing process, specifications and controls for ensuring consistent quality batches. It also covers CMC regulatory compliance after approval and post-approval regulatory requirements to ensure continued safety and effectiveness. The goal of CMC regulatory affairs is to provide the necessary CMC information and strategy to obtain and maintain regulatory approvals.
The document provides guidance on stability testing and data requirements for biotechnological/biological products. It recommends that stability data be provided for at least 3 batches of the drug substance manufactured at pilot scale and stored under intended conditions for 6 months or longer. For drug products, data is required from 3 batches derived from different drug substance batches, with a minimum of 6 months data if a shelf life greater than 6 months is claimed. Products should be tested regularly as per predefined protocols, with more frequent testing in early time periods. Specifications should include stability-indicating parameters to monitor purity, identity, potency and other characteristics over the proposed shelf life.
ICH Guideline Stability Testing of New Drug Substances and Product Q1A(R2).pptxTrishala Bhatt
This presentation outlines the ICH Guideline for Stability Testing of New Drug Substances and Products, Q1A(R2). It serves as a comprehensive framework for ensuring the stability of new pharmaceuticals, with a focus on the requirements for registration applications within the EC, Japan, and the United States. The guideline emphasizes a balance between a standardized approach and the flexibility to adapt to specific scientific considerations and characteristics of the materials under evaluation.
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.
This document discusses regulatory and quality assurance considerations for drug product development. It outlines that CMC development should ensure patient safety and product quality through standards like GMP. Information provided to regulators should increase in detail as development progresses from Phase 1 to Phase 3. The quality assurance function is responsible for independent assessment and oversight of manufacturing to ensure standards are met.
This document discusses regulatory and quality assurance considerations for drug product development. It outlines that CMC development should ensure patient safety and proceed simultaneously with clinical trials. Information generated at each stage of development should build upon early work and support product approval. The roles of quality assurance, quality control, and regulatory affairs are described. Guidance is provided on the type of CMC information needed for original INDs and as development progresses towards an NDA.
Presented at length on 23 April and 21 May 2017 at ICCBS, HEJ and Getz Pharma Auditorium, Karachi in a Discussion Forum of about 800 practicing university qualified professionals of various pharmaceutical manufacturing industries
This document summarizes a discussion forum on ICH Q7 & Q11 regarding DMFs, impurities, CTD, and challenges. It provides an outline of drug master files, types of DMFs, classes of impurities in APIs, elements of a control strategy, sections of the common technical document that contain established conditions, and challenges faced. The presentation focused on established conditions, control strategies, their relationship, and how established conditions are presented in CTD sections.
This document outlines chemistry, manufacturing, and controls (CMC) requirements for a marketing authorization application of a drug product. It identifies several areas that require further information, clarification, or validation for the drug substance, excipients, manufacturing process, process controls, specifications, and analytical procedures. Key issues noted include a lack of justification for excipient use, incomplete pharmaceutical development reports, missing process validation data, insufficient characterization of impurities, and non-compliance of some specifications and analytical methods with pharmacopeial standards. Additional data is requested to address these deficiencies before the application can be filed.
This document summarizes key ICH guidelines related to quality and stability testing. It defines key terms like drug substance, dosage form, drug product, and finished pharmaceutical product. It describes the types of studies conducted for drug substances and products under various storage conditions to establish shelf life and re-test periods. These include long term, intermediate, and accelerated studies. It also summarizes ICH guidelines on specific topics like stability testing (Q1A-Q1F), validation of analytical procedures (Q2), impurities (Q3A-Q3C), and others.
The document provides guidelines for stability testing of pharmaceuticals. It defines stability testing as tests designed to obtain information on a product's stability to define its shelf life and utilization period under specified storage conditions. The objectives are to select adequate formulations, determine shelf life and storage conditions, substantiate the claimed shelf life, and verify no changes adversely affecting stability. The guidelines address information required for new drug substances and products and covers phases of testing including development, registration, and post-registration. It provides details on design of studies for drug substances and products, storage conditions, testing frequency and evaluation.
The document provides guidelines for specifications of new drug substances and products. It discusses setting specifications based on development data and stability studies. Universal tests for drug substances include identification, assay, impurities. For products, additional tests depend on dosage form and may include dissolution, uniformity, sterility. The guidelines provide concepts for justifying specifications and periodic testing. They apply principles for biotech products, addressing characterization, analytical validation, process controls, and linking specifications to manufacturing and clinical data.
This document provides a summary of guidelines for stability testing of biotechnological/biological products. It discusses the need for stringent stability testing programs for these products given their sensitivity to environmental factors. It recommends testing the drug substance and drug product from at least 3 batches that represent the manufacturing scale. A minimum of 6 months of real-time, real-condition stability data should be submitted initially to support the requested storage period. The quality of batches in the stability program should match what was used in clinical studies. Ongoing updates of stability data may be needed during regulatory review.
Dr. Abhijath's RA Document (CMC, Post Approvals, Regulation of Combination Pr...Abhijath Murali
Dear All,
Sharing the Information on Regulatory Affairs: CMC, Post Approvals, Regulation of Combination Products & Medical Devices.
Hope It would be helpful for you in your Future Journey.
All the Best!
With Regards,
Dr. Abhijath Murali
ICH guidelines on impurities in new drug products.pptxDivya Pushp
This document provides a summary of a presentation on ICH guidelines for impurities in new drug products. The guidelines provide guidance for registration applications on reporting and qualifying degradation products and impurities. Key points include: analytical procedures must be validated for detecting degradation products; batches used in development and commercial processes must be compared; degradation products above certain thresholds must be identified, reported, and qualified; and specifications for degradation products should be based on batches from the commercial process. The guidelines do not apply to certain product types like biologics but provide direction on identifying, analyzing, reporting, and qualifying degradation products found in new small molecule drug products.
The document discusses key aspects of validating solid dosage forms such as tablets. It emphasizes that quality must be built into the product from the beginning, starting with validating the characteristics of the active pharmaceutical ingredients and excipients used. Analytical methods, manufacturing equipment, and the entire production process must also be validated to ensure reproducible quality batches. The validation program involves defining critical material attributes, establishing control parameters, and testing batches to set specification limits to maintain process control.
This presentation discusses the revision of the FDA's Question-based Review (QbR) system for generic drug submissions. The QbR questions were revised to fully incorporate quality-by-design (QbD) elements like quality target product profiles and critical quality attributes. Key changes include removing questions answered with 'refer to DMF' and revising 'yes/no' questions. The revised QbR aims to facilitate a more science- and risk-based review of generic drug applications and further encourage QbD principles. A mock application and FAQ are in development to aid understanding of the new QbR. Feedback on the revised questions is welcome.
This document provides guidance on IND (Investigational New Drug) regulations for initial Phase 1 clinical trials. It clarifies that Phase 1 IND submissions require basic information to ensure safety rather than detailed development plans. For protocols, manufacturing information, and other sections, flexibility is allowed to adapt to early study results. The focus should be on safety aspects like monitoring and dose adjustments rather than predetermined experimental designs. This guidance aims to help sponsors provide sufficient information without being overly burdensome for early phase trials.
This document defines stability testing requirements for new drug products. It outlines that three primary batches packaged in the proposed marketing container closure system should undergo long term testing at 25°C/60% RH or 30°C/65% RH, accelerated testing at 40°C/75% RH, and intermediate testing if needed. Specifications, frequency of testing, storage conditions and a post-approval stability commitment are also addressed. The purpose is to provide evidence of a drug product's quality over time under various environmental conditions and establish a shelf life.
This document summarizes guidelines for stability testing according to ICH guidelines. The key points are:
1) ICH guidelines are most commonly accepted and provide information on stability testing in the EU, Japan, and US. Stability testing aims to provide evidence of how quality varies over time under different conditions.
2) The objectives of ICH are more economical use of resources, eliminating delays in global development and availability of medicines, and maintaining safeguards for quality, safety, and efficacy.
3) Stability topics covered by ICH include testing, validation, impurities, specifications, and manufacturing. This summary focuses on stability testing guidelines for new drug substances and products.
Current Good Manufacturing Practices (cGMP) are followed by pharmaceutical and biotechnology companies
Items are manufactured to specific requirements including identity, strength, quality, and purity. Good Manufacturing Practices are regulated by the Food and Drug Administration (FDA)
This guideline describes the suggested contents for the 3.2.P.2 (Pharmaceutical
Development) section of a regulatory submission in the ICH M4 Common Technical
Document (CTD) format. The Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management (for definition, see ICH Q9) to the development of a product and its
manufacturing process. It is first produced for the original marketing application and
can be updated to support new knowledge gained over the lifecycle of a product. The
Pharmaceutical Development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviewers and inspectors. The guideline also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided.
This guideline describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical
Document (CTD) format. The Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management (for definition, see ICH Q9) to the development of a product and its manufacturing process. It is first produced for the original marketing application andcan be updated to support new knowledge gained over the lifecycle of a product. The Pharmaceutical Development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviewers and inspectors. The guideline also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided.
This document provides guidance on setting specifications for biotechnological and biological products. It outlines principles for characterizing products and establishing acceptance criteria based on physicochemical properties, biological activity, immunogenicity, purity, and impurities. Specifications should be justified based on data from lots used in clinical studies and manufacturing consistency lots. The document provides appendices on characterization techniques and types of impurities to consider.
As Mumbai's premier kidney transplant and donation center, L H Hiranandani Hospital Powai is not just a medical facility; it's a beacon of hope where cutting-edge science meets compassionate care, transforming lives and redefining the standards of kidney health in India.
Presented at length on 23 April and 21 May 2017 at ICCBS, HEJ and Getz Pharma Auditorium, Karachi in a Discussion Forum of about 800 practicing university qualified professionals of various pharmaceutical manufacturing industries
This document summarizes a discussion forum on ICH Q7 & Q11 regarding DMFs, impurities, CTD, and challenges. It provides an outline of drug master files, types of DMFs, classes of impurities in APIs, elements of a control strategy, sections of the common technical document that contain established conditions, and challenges faced. The presentation focused on established conditions, control strategies, their relationship, and how established conditions are presented in CTD sections.
This document outlines chemistry, manufacturing, and controls (CMC) requirements for a marketing authorization application of a drug product. It identifies several areas that require further information, clarification, or validation for the drug substance, excipients, manufacturing process, process controls, specifications, and analytical procedures. Key issues noted include a lack of justification for excipient use, incomplete pharmaceutical development reports, missing process validation data, insufficient characterization of impurities, and non-compliance of some specifications and analytical methods with pharmacopeial standards. Additional data is requested to address these deficiencies before the application can be filed.
This document summarizes key ICH guidelines related to quality and stability testing. It defines key terms like drug substance, dosage form, drug product, and finished pharmaceutical product. It describes the types of studies conducted for drug substances and products under various storage conditions to establish shelf life and re-test periods. These include long term, intermediate, and accelerated studies. It also summarizes ICH guidelines on specific topics like stability testing (Q1A-Q1F), validation of analytical procedures (Q2), impurities (Q3A-Q3C), and others.
The document provides guidelines for stability testing of pharmaceuticals. It defines stability testing as tests designed to obtain information on a product's stability to define its shelf life and utilization period under specified storage conditions. The objectives are to select adequate formulations, determine shelf life and storage conditions, substantiate the claimed shelf life, and verify no changes adversely affecting stability. The guidelines address information required for new drug substances and products and covers phases of testing including development, registration, and post-registration. It provides details on design of studies for drug substances and products, storage conditions, testing frequency and evaluation.
The document provides guidelines for specifications of new drug substances and products. It discusses setting specifications based on development data and stability studies. Universal tests for drug substances include identification, assay, impurities. For products, additional tests depend on dosage form and may include dissolution, uniformity, sterility. The guidelines provide concepts for justifying specifications and periodic testing. They apply principles for biotech products, addressing characterization, analytical validation, process controls, and linking specifications to manufacturing and clinical data.
This document provides a summary of guidelines for stability testing of biotechnological/biological products. It discusses the need for stringent stability testing programs for these products given their sensitivity to environmental factors. It recommends testing the drug substance and drug product from at least 3 batches that represent the manufacturing scale. A minimum of 6 months of real-time, real-condition stability data should be submitted initially to support the requested storage period. The quality of batches in the stability program should match what was used in clinical studies. Ongoing updates of stability data may be needed during regulatory review.
Dr. Abhijath's RA Document (CMC, Post Approvals, Regulation of Combination Pr...Abhijath Murali
Dear All,
Sharing the Information on Regulatory Affairs: CMC, Post Approvals, Regulation of Combination Products & Medical Devices.
Hope It would be helpful for you in your Future Journey.
All the Best!
With Regards,
Dr. Abhijath Murali
ICH guidelines on impurities in new drug products.pptxDivya Pushp
This document provides a summary of a presentation on ICH guidelines for impurities in new drug products. The guidelines provide guidance for registration applications on reporting and qualifying degradation products and impurities. Key points include: analytical procedures must be validated for detecting degradation products; batches used in development and commercial processes must be compared; degradation products above certain thresholds must be identified, reported, and qualified; and specifications for degradation products should be based on batches from the commercial process. The guidelines do not apply to certain product types like biologics but provide direction on identifying, analyzing, reporting, and qualifying degradation products found in new small molecule drug products.
The document discusses key aspects of validating solid dosage forms such as tablets. It emphasizes that quality must be built into the product from the beginning, starting with validating the characteristics of the active pharmaceutical ingredients and excipients used. Analytical methods, manufacturing equipment, and the entire production process must also be validated to ensure reproducible quality batches. The validation program involves defining critical material attributes, establishing control parameters, and testing batches to set specification limits to maintain process control.
This presentation discusses the revision of the FDA's Question-based Review (QbR) system for generic drug submissions. The QbR questions were revised to fully incorporate quality-by-design (QbD) elements like quality target product profiles and critical quality attributes. Key changes include removing questions answered with 'refer to DMF' and revising 'yes/no' questions. The revised QbR aims to facilitate a more science- and risk-based review of generic drug applications and further encourage QbD principles. A mock application and FAQ are in development to aid understanding of the new QbR. Feedback on the revised questions is welcome.
This document provides guidance on IND (Investigational New Drug) regulations for initial Phase 1 clinical trials. It clarifies that Phase 1 IND submissions require basic information to ensure safety rather than detailed development plans. For protocols, manufacturing information, and other sections, flexibility is allowed to adapt to early study results. The focus should be on safety aspects like monitoring and dose adjustments rather than predetermined experimental designs. This guidance aims to help sponsors provide sufficient information without being overly burdensome for early phase trials.
This document defines stability testing requirements for new drug products. It outlines that three primary batches packaged in the proposed marketing container closure system should undergo long term testing at 25°C/60% RH or 30°C/65% RH, accelerated testing at 40°C/75% RH, and intermediate testing if needed. Specifications, frequency of testing, storage conditions and a post-approval stability commitment are also addressed. The purpose is to provide evidence of a drug product's quality over time under various environmental conditions and establish a shelf life.
This document summarizes guidelines for stability testing according to ICH guidelines. The key points are:
1) ICH guidelines are most commonly accepted and provide information on stability testing in the EU, Japan, and US. Stability testing aims to provide evidence of how quality varies over time under different conditions.
2) The objectives of ICH are more economical use of resources, eliminating delays in global development and availability of medicines, and maintaining safeguards for quality, safety, and efficacy.
3) Stability topics covered by ICH include testing, validation, impurities, specifications, and manufacturing. This summary focuses on stability testing guidelines for new drug substances and products.
Current Good Manufacturing Practices (cGMP) are followed by pharmaceutical and biotechnology companies
Items are manufactured to specific requirements including identity, strength, quality, and purity. Good Manufacturing Practices are regulated by the Food and Drug Administration (FDA)
This guideline describes the suggested contents for the 3.2.P.2 (Pharmaceutical
Development) section of a regulatory submission in the ICH M4 Common Technical
Document (CTD) format. The Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management (for definition, see ICH Q9) to the development of a product and its
manufacturing process. It is first produced for the original marketing application and
can be updated to support new knowledge gained over the lifecycle of a product. The
Pharmaceutical Development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviewers and inspectors. The guideline also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided.
This guideline describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical
Document (CTD) format. The Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management (for definition, see ICH Q9) to the development of a product and its manufacturing process. It is first produced for the original marketing application andcan be updated to support new knowledge gained over the lifecycle of a product. The Pharmaceutical Development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviewers and inspectors. The guideline also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided.
This document provides guidance on setting specifications for biotechnological and biological products. It outlines principles for characterizing products and establishing acceptance criteria based on physicochemical properties, biological activity, immunogenicity, purity, and impurities. Specifications should be justified based on data from lots used in clinical studies and manufacturing consistency lots. The document provides appendices on characterization techniques and types of impurities to consider.
As Mumbai's premier kidney transplant and donation center, L H Hiranandani Hospital Powai is not just a medical facility; it's a beacon of hope where cutting-edge science meets compassionate care, transforming lives and redefining the standards of kidney health in India.
English Drug and Alcohol Commissioners June 2024.pptxMatSouthwell1
Presentation made by Mat Southwell to the Harm Reduction Working Group of the English Drug and Alcohol Commissioners. Discuss stimulants, OAMT, NSP coverage and community-led approach to DCRs. Focussing on active drug user perspectives and interests
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Solution manual for managerial accounting 18th edition by ray garrison eric n...rightmanforbloodline
Solution manual for managerial accounting 18th edition by ray garrison eric noreen and peter brewer_compressed
Solution manual for managerial accounting 18th edition by ray garrison eric noreen and peter brewer_compressed
Digital Health in India_Health Informatics Trained Manpower _DrDevTaneja_15.0...DrDevTaneja1
Digital India will need a big trained army of Health Informatics educated & trained manpower in India.
Presently, generalist IT manpower does most of the work in the healthcare industry in India. Academic Health Informatics education is not readily available at school & health university level or IT education institutions in India.
We look into the evolution of health informatics and its applications in the healthcare industry.
HIMMS TIGER resources are available to assist Health Informatics education.
Indian Health universities, IT Education institutions, and the healthcare industry must proactively collaborate to start health informatics courses on a big scale. An advocacy push from various stakeholders is also needed for this goal.
Health informatics has huge employment potential and provides a big business opportunity for the healthcare industry. A big pool of trained health informatics manpower can lead to product & service innovations on a global scale in India.
The Importance of Black Women Understanding the Chemicals in Their Personal C...bkling
Certain chemicals, such as phthalates and parabens, can disrupt the body's hormones and have significant effects on health. According to data, hormone-related health issues such as uterine fibroids, infertility, early puberty and more aggressive forms of breast and endometrial cancers disproportionately affect Black women. Our guest speaker, Jasmine A. McDonald, PhD, an Assistant Professor in the Department of Epidemiology at Columbia University in New York City, discusses the scientific reasons why Black women should pay attention to specific chemicals in their personal care products, like hair care, and ways to minimize their exposure.
Research, Monitoring and Evaluation, in Public Healthaghedogodday
This is a presentation on the overview of the role of monitoring and evaluation in public health. It describes the various components and how a robust M&E system can possitively impact the results or effectiveness of a public health intervention.
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Our Spa in Ajman stands out for its effectiveness in enhancing wellness. Our therapists focus on treating the root cause of issues, providing tailored treatments for each client. We take pride in offering the most satisfying Pakistani Spa service, adjusting treatment plans based on client feedback.
For the most result-oriented Russian Spa treatment in Ajman, visit our Massage Center. Our Russian therapists are skilled in various techniques to address health concerns. Our body-to-body massage is efficient due to individualized care and high-grade massage oils.
Test bank clinical nursing skills a concept based approach 4e pearson educati...rightmanforbloodline
Test bank clinical nursing skills a concept based approach 4e pearson education
Test bank clinical nursing skills a concept based approach 4e pearson education
Test bank clinical nursing skills a concept based approach 4e pearson education
NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPTblessyjannu21
Prepared by Prof. BLESSY THOMAS, VICE PRINCIPAL, FNCON, SPN.
Emphysema is a disease condition of respiratory system.
Emphysema is an abnormal permanent enlargement of the air spaces distal to terminal bronchioles, accompanied by destruction of their walls and without obvious fibrosis.
Emphysema of lung is defined as hyper inflation of the lung ais spaces due to obstruction of non respiratory bronchioles as due to loss of elasticity of alveoli.
It is a type of chronic obstructive
pulmonary disease.
It is a progressive disease of lungs.
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The Ultimate Guide in Setting Up Market Research System in Health-TechGokul Rangarajan
How to effectively start market research in the health tech industry by defining objectives, crafting problem statements, selecting methods, identifying data collection sources, and setting clear timelines. This guide covers all the preliminary steps needed to lay a strong foundation for your research.
"Market Research it too text-booky, I am in the market for a decade, I am living research book" this is what the founder I met on the event claimed, few of my colleagues rolled their eyes. Its true that one cannot over look the real life experience, but one cannot out beat structured gold mine of market research.
Many 0 to 1 startup founders often overlook market research, but this critical step can make or break a venture, especially in health tech.
But Why do they skip it?
Limited resources—time, money, and manpower—are common culprits.
"In fact, a survey by CB Insights found that 42% of startups fail due to no market need, which is like building a spaceship to Mars only to realise you forgot the fuel."
Sudharsan Srinivasan
Operational Partner Pitchworks VC Studio
Overconfidence in their product’s success leads founders to assume it will naturally find its market, especially in health tech where patient needs, entire system issues and regulatory requirements are as complex as trying to perform brain surgery with a butter knife. Additionally, the pressure to launch quickly and the belief in their own intuition further contribute to this oversight. Yet, thorough market research in health tech could be the key to transforming a startup's vision into a life-saving reality, instead of a medical mishap waiting to happen.
Example of Market Research working
Innovaccer, founded by Abhinav Shashank in 2014, focuses on improving healthcare delivery through data-driven insights and interoperability solutions. Before launching their platform, Innovaccer conducted extensive market research to understand the challenges faced by healthcare organizations and the potential for innovation in healthcare IT.
Identifying Pain Points: Innovaccer surveyed healthcare providers to understand their difficulties with data integration, care coordination, and patient engagement. They found widespread frustration with siloed systems and inefficient workflows.
Competitive Analysis: Analyzed competitors offering similar solutions in healthcare analytics and interoperability. Identified gaps in comprehensive data aggregation, real-time analytics, and actionable insights.
Regulatory Compliance: Ensured their platform complied with HIPAA and other healthcare data privacy regulations. This compliance was crucial to gaining trust from healthcare providers wary of data security issues.
Customer Validation: Conducted pilot programs with several healthcare organizations to validate the platform's effectiveness in improving care outcomes and operational efficiency. Gathered feedback to refine features and user interface.
1. Core of the CTD-Module 3
-MOHANA THAKKAR
M. PHARM (PHARMACEUTICS)
DATE:23 SEPTEMBER 2022
2. Objective
To provide insight about expectations of
GCC and Health Canada on Quality (CMC)
portion in submission/application by
Sponsor.
3. Module 3-Quality
• The Quality section of the Common Technical Document provides a harmonized
structure and format for presenting CMC (Chemistry, Manufacturing and
Controls) information in a registration dossier.
Module 3 content
Module Content
3.1 Module 3 table of contents
3.2 Body of data
3.3 Literature references
4. 3.2 BODY OF
DATA
3.2.S Drug Substance:
The drug substance information can be submitted in one of
the following options:
1. Certificate of suitability (CEP); or
2. Drug master file (DMF); or
3. Complete information on the “3.2.S drug substance”
sections.
GCC: Unless justified, the number of Active Pharmaceutical
Ingredients (API) suppliers must not exceed two sources for
each API.
5. 3.2.S.1 General
Information
3.2.S.1.1 Nomenclature:
Information on the nomenclature of the drug substance(s) should
be provided. E.g.: Recommended International Nonproprietary
Name (INN).
3.2.S.1.2 Structure:
The structural formula, including relative and absolute
stereochemistry, the molecular formula, and the relative molecular
mass should be provided.
3.2.S.1.3 General Properties:
Physicochemical and other relevant properties of the drug substance
should be listed.
E.g.: Appearance, Polymorphic form, Solubility profile, Partition
coefficients, melting or boiling points.
6. 3.2.S.2
Manufacture
3.2.S.2.1 Manufacturer(s):
The name, address, and responsibility of each manufacturer.
3.2.S.2.2 Description of Process and Process Controls:
Detailed information on the starting material(s) including the
name of the manufacturer(s)/supplier(s), route of synthesis
and specifications which should be justified by supporting
data.
3.2.S.2.3 Control of Materials:
For each starting material, the name, manufacturing site,
and the address of each manufacturer should be indicated.
7. 3.2.S.2
Manufacture
3.2.S.2.4 Control of Critical Steps and Intermediates:
Tests & Acceptance criteria performed at critical steps.
3.2.S.2.5 Process Validation and/or Evaluation:
Process validation studies for aseptic processing and
sterilization.
For non-sterile drug substances, process validation and/or
evaluation studies need not be provided in a regulatory
submission.
3.2.S.2.6 Manufacturing Process Development:
Significant changes made to the manufacturing process
and/or manufacturing site of the drug substance.
8. 3.2.S.3
Characterization
3.2.S.3.1 Elucidation of Structure and Other Characteristics:
Confirmation of structure based on synthetic route and spectral
analyses.
For pharmacopeial drug substance(s):
GCC: copies of the IR spectrum of the drug substance run
concomitantly with a reference standard.
CANADA: copies of the Infrared (IR) and Ultraviolet (UV) spectra of
the drug substance for each source.
3.2.S.3.2 Impurities:
Drug-Related Impurities (e.g., API starting materials, by-products,
intermediates, chiral impurities, degradation products).
Process-related impurities (e.g., residual solvents, reagents,
catalysts).
9. 3.2.S.4 Control
of Drug
Substance
3.2.S.4.1 Specifications:
Both-DS & DP manufacturer.
Tests, acceptance criteria and reference to analytical methods.
Health Canada:
The assay should include the chemical formula so that it is clear
as to how the dose is declared (i.e., free acid/base vs. salt)
Injectable products: Bacterial endotoxins test with an
appropriate limit should be included.
3.2.S.4.2 Analytical Procedure:
The analytical procedures used for testing the drug substance.
Not necessary to provide copies of the compendial analytical
procedures.
Health Canada: HPLC/UPLC-Method of choice for determining
drug-related impurities.
GCC: HPLC/GC-Method of choice for determining drug-related
impurities.
10. 3.2.S.4.3 Validation of Analytical Procedures:
Analytical validation information including experimental data for the
analytical procedures.
For in-house methods, full validation are required.
Verification of compendial methods is necessary. Why ?
Compendial methods are typically validated based on an API originating
from a specific manufacturer. Different sources of the same API can contain
impurities and/or degradation products that were not considered during
the development of the monograph.
If Compendial method used to control API-related impurity, not specified in
monograph?
Full validation of the method is expected with respect to those impurities.
If compendial standard is claimed and an in-house method is used as an
alternative method (e.g., for assay or specified impurities)?
Equivalence of the in-house and compendial methods should be
demonstrated.
11. 3.2.S.4.4 Batch Analyses
Description of batches and results of batch analyses.
The discussion of results should focus on observations noted for
the various tests, rather than reporting as “All tests meet
specifications”.
3.2.S.4.5 Justification of Specification
Discussion on the inclusion of certain tests, evolution of tests,
analytical procedures and acceptance criteria, etc.
12. 3.2.S.5 Reference Standards or Materials
The source of reference standards or reference
materials (e.g., House, USP, BP, Ph. Eur.).
Certificate of analysis for reference standards or
reference materials .
Characterization and evaluation of non-compendial
reference standards (e.g., method of manufacture,
elucidation of structure, certificate of analysis,
calibration against an official standard).
3.2.S.6 Container/Closure Systems
Identification of materials of construction of each
primary packaging component and their specifications.
Compatibility
Certificate of Compliance
13. 3.2.S.7 Stability
3.2.S.7.1 Stability Summary and Conclusions:
Type of studies
Protocols
Results of the studies
Information: storage conditions, batch number, batch
size, batch type, batch manufacturing date, container
closure system and testing intervals (completed and
proposed), results and conclusion.
Health Canada: If route of synthesis is changed, then
results for at least 2 pilot scale batches with minimum of
3 months of long-term and accelerated testing should be
provided at the time of filing.
14. General case for stability studies of the drug substance
Study Storage condition Minimum time period covered
by data at submission
GCC Health Canada
Long-term 30℃ ± 2℃/ 65% RH±
5% RH
OR
30 °C ± 2 °C/75% RH ±
5% RH
25°C ± 2°C / 60% RH ±
5% RH
GCC : 12 months
Health Canada: 12 months
(6 months for existing
drug substances)
Accelerated 40℃ ± 2℃/ 75% RH±
5% RH
40°C ± 2°C / 75% RH ±
5% RH
Intermediate - 30°C ± 2°C / 65% RH ±
5% RH
6 months (if applicable as per
ICH)
15. 3.2.S.7.2 Post-
approval Stability
Protocol and
Commitment
At least one batch per year of
API manufactured at each
commercial site (unless none is
produced that year) should be
added to the continuing
stability monitoring program.
GCC: If stability data on
Primary batches is submitted, a
commitment to place the first
two/three production batches
on long-term stability studies
through the proposed retest
period should be provided.
GCC Guidelines Health Canada
a. Number of batch(s) and
different batch sizes
b. Relevant physical, chemical,
microbiological and biological
test methods;
c. Acceptance criteria;
d. Reference to test methods;
e. Description of the container
closure system(s);
f. Testing frequency;
g. Description of the conditions
of storage
a. Number of batches and
batch sizes;
b. Tests and acceptance
criteria;
c. Container closure
system(s);
d. Testing frequency; and
e. Storage conditions (and
tolerances) of samples.
Minimum requirements:
16. 3.2.S.7.3
Stability Data
GCC Guidelines Health Canada
• Results to be provided in tabular
format. Separate table for each
batch.
• Results to be provided in
tabular, graphical, or
narrative.
• Actual numerical results should
be provided. Vague statements -
“within limits” or “conforms”
shall not be mentioned.
• If significant change observed
between three and six months’
testing at accelerated storage
condition, re-test period to be
proposed based on long-term
storage condition.
• If significant change
observed between three
and six months’ testing at
accelerated storage
condition, intermediate
condition testing
recommended.
17. 3.2.P Drug Product:
3.2.P.1 Description and Composition of the Drug Product:
Description of the dosage form;
Detailed composition with overages, if any on a per unit basis and function of each component.
Quality standard and grades (e.g., “Microcrystalline Cellulose NF (PH 102)”)
Reconstitution diluent
Health Canada: Intra and extra-granular excipients should be listed separately in tabular
form.
Container and closure used for the dosage form.
18. 3.2.P.2 Pharmaceutical Development
Essentials:
1. Components of the Drug Product
2. Drug Product: Formulation development, Overages, Physicochemical, Biological Properties.
3. Manufacturing Process Development
4. Container Closure System
5. Microbiological Attributes
6. Compatibility
Quality by Design Approach:
Defining QTPP (Quality Target Product Profile): Targeting Product Profile of desired Quality.
CQAs (Critical Quality Attributes), CMAs (Critical Material Attributes), CPPs (Critical Process
Parameters)
19. 3.2.P.3
Manufacture
3.2.P.3.1 Manufacturer(s): name, address, and
responsibility of each manufacturer, including contractors,
and each proposed production site involved in
manufacturing and testing.
GCC: Manufacturing Authorization, Marketing Authorization
and GMP certificate.
3.2.P.3.2 Batch Formula:
All proposed individual batch sizes.
All components of the dosage form (may or may not appear
in Final Drug product, e.g., Solvents)
GCC: Official letter indicating the expected production size
range and confirmation that the range will not be changed
before getting Prior approval.
20. Flow diagram of the manufacturing process with Critical
Process Parameters.
A narrative description of the manufacturing process,
including packaging.
Sterile Products: validated sterilization parameters (e.g.,
load size, autoclave program, gamma radiation dose,
processing aids) and equipment (e.g., compounding vessels,
sterilizing filters, filling syringes).
GCC: the class of the areas (e.g., A, B, …etc) should be
stated for each activity (e.g., compounding).
3.2.P.3.3 Description of
Manufacturing Process
and Process Controls:
21. 3.2.P.3.4
Controls of
Critical Steps
and
Intermediates
Critical Steps: Tests and acceptance criteria should be provided.
Intermediates: Information on the quality and control of intermediates
isolated during the process.
Examples: Potential In-process controls:
(i) granulations:moisture, blend uniformity, bulk and tapped densities.
(ii) solid oral products: average weight, weight variation, hardness, thickness,
friability.
(iii) semi-solids: viscosity, homogeneity, pH, evaluation of phase separation.
(iv) transdermal patches: assay of drug-adhesive mixture.
(v) metered dose inhalers: fill weight/volume, leak testing.
(vi) dry powder inhalers: assay of drug-excipient blend, moisture.
(vii) liquids: pH, specific gravity, bioburden.
(viii) parenteral: bioburden prior to sterilization (Health Canada),
100% visual inspection (appearance, clarity), pH, fill volume/weight, filter
integrity, particulate matter, container closure integrity test.
Health Canada: Maximum recommended limits for in-process weight
variation.
22. 3.2.P.3.5
Process
Validation
and/or
Evaluation
Description, documentation, and results of the validation and/or
evaluation studies.
Health Canada: Process Validation Protocol or Validation Report
GCC: Process Validation Protocol and “A letter of commitment” to conduct
prospective validation on three consecutive production scale batches and to
report immediately any out of specification (OOS) results to the authority.
Sterile Products:
Health Canada: Validation should be completed prior to submission and
Validation Report to be provided with summary of process validation studies.
GCC: “A letter of commitment” to conduct prospective validation on three
consecutive production scale batches including the sterilization process and to
report immediately any out of specification (OOS) results to the authority.
23. 3.2.P.4 Control
of Excipients
3.2.P.4.1 Specifications:
Health Canada: Specifications for only non-compendial monograph.
GCC: Specifications to be provided also if standard claimed is compendial
monograph.
3.2.P.4.2 Analytical Procedures:
Non-compendial analytical procedures used to generate testing results.
3.2.P.4.3 Validation of Analytical Procedures:
Analytical validation information, including experimental data, for the non-
compendial analytical procedures used for testing the excipients.
3.2.P.4.4 Justification of Specifications:
Discussions on tests supplementary to compendial monograph.
Certificate of Analysis from Vendor and Supplier (FP manufacturer).
24. 3.2.P.4.5 Excipients of Human or Animal Origin:
List of excipients of human or animal origin.
TSE/BSE certificate.
3.2.P.4.6 Novel Excipients:
Excipients used for the first time in a drug product or by a new
route of administration.
Details of manufacture, characterization, and controls, with
supporting safety data (nonclinical and/or clinical) should be
provided according to the drug substance format.
(Details to be included in 3.2.A.3).
25. 3.2.P.5 Control
of Drug Product
3.2.P.5.1 Specifications:
Release and Shelf-Life Specifications.
Acceptance criteria for Release Specifications should be more stringent.
Why?
To ensure that shelf-life acceptance criteria are met throughout the labelled
shelf life of the drug product.
Health Canada: Drug product specifications in accordance with C.02.018
and C.02.019 of the Food and Drug Regulations from the site responsible for
release (e.g., drug product manufacturer, importer or distributor).
The assay should include the chemical formula.
Dissolution method parameters (e.g., dissolution apparatus, rotation speed,
dissolution medium and volume) should be listed as a footnote to the table
or directly in the description of the test.
Minimum Specifications:
GCC: Appearance, identification, assay, purity, pharmaceutical tests (e.g.,
dissolution), physical tests (e.g. loss on drying, hardness, friability, particle
size, apparent density), uniformity of dosage units, identification of coloring
materials, identification and assay of antimicrobial or chemical preservatives
(e.g., antioxidants) and microbial limit tests.
26. 3.2.P.5 Control
of Drug Product
Specific tests and criteria that are not addressed by ICH’s
Q6A guideline.
Health Canada:
Recommended tests to be included in Specifications:
Dosage Form Specific Tests Recommended*
Modified-release products Drug –Release method discriminatory with
respect to formulation.
Inhalation and Nasal
Products
Consistency of delivered dose, particle size
distribution, moisture content, leak rate, microbial
limits, preservative assay, sterility, and weight loss.
Suppositories Uniformity of dosage units, melting point.
Transdermals Peel or shear force, mean weight per unit area, in
vitro drug release, monitoring for crystal growth.
Aqueous Solutions pH, uniformity of dosage units, antimicrobial
preservative content, antioxidant preservative
content, osmolality/osmolarity, particulate matter
(for sterile products)
Sterile solutions - sterility, bacterial endotoxins
27. 3.2.P.5.2 Analytical Procedures
Non-compendial analytical procedures.
GCC: HPLC & GC are method of choice for Impurities determination and Assay.
System suitability tests (SSTs) are an integral part of the method. Why?
To ensure the satisfactory performance of the chosen chromatographic system.
HPLC and GC purity methods should include SSTs for resolution and repeatability.
3.2.P.5.3 Validation of Analytical Procedures:
Analytical validation information, including experimental data.
Validation reports for non-compendial analytical procedures.
Verification for compendial methods: Specificity, Accuracy and Repeatability.
GCC: If compendial method is used to control related substances, not specified in monograph, full method validation for
related substances to be submitted.
28. 3.2.P.5.4 Batch
Analyses
Description of batches and
batch analysis results.
Deviations and Out of
Specification (OOS) test results
should be investigated and
summarized.
Number of batches and batch sizes
Health Canada GCC
1. Minimum three batches-minimum pilot scale. 1. Minimum two pilot
scale batches.
Pilot scale batch requirement: -
• Solid oral dosage forms-Minimum 1/10th of full
production scale or 1,00,000 tablets or
capsules, whichever larger.
-
• Liquid dosage forms & Powder for
reconstitution into solution: Minimum 1/10th of
full production scale or 20 litres, whichever is
the larger. If proposed commercial batch size is
<20 Litres, maximum proposed commercial
batch size.
-
29. 3.2.P.5.5 Characterization of Impurities
Potential degradation products and finished product process-related
impurities.
3.2.P.5.6 Justification of Specifications
Discussions on omission or inclusion of certain tests, evolution of tests,
analytical procedures and acceptance criteria, differences from the
compendial standard(s).
3.2.P.6 Reference Standards or Materials
Source of Reference Standards/Materials (USP, BP, etc.)
COA of Reference Standards
Characterization and evaluation of non-official (e.g., non- compendial)
reference standards.
3.2.P.7 Container/Closure System
COA, Specifications and Method of Analysis (Non-compendial) for all
primary packaging components.
A brief description for secondary packaging components.
Health Canada: Specifications, from both-Vendor and Drug Product
manufacturer.
Certificates of compliance (Vendor/Drug Product manufacturer)
30. 3.2.P.8 Stability
3.2.P.8.1 Stability Summary and Conclusions
Summary of types of studies conducted, protocols used and the results of the studies.
GCC: “Stability Testing of Active Pharmaceutical Ingredients (APIs) and Finished
Pharmaceutical Products (FPPs)” guideline of GCC should be followed.
Health Canada: ICH Q1A, Q1B, Q1C, Q1D, Q1E
Summary of Types of studies conducted, Protocols used and the results.
Photostability testing should be conducted on at least one primary batch of the drug product.
In-use stability studies. (One of the batches towards end of its shelf life).
For a drug product posing a higher risk (e.g., sterile drug product), transportation study is
required.
31. General case for stability studies of the drug product
Study Storage condition Minimum time period covered by data
at submission
GCC Region Canada
Long-term 30℃ ± 2℃/ 65% RH±
5% RH
OR
30 °C ± 2 °C/75% RH ±
5% RH
25°C ± 2°C / 60% RH ±
5% RH
GCC region: 12 months
Health Canada: 12 months
(6 months for existing drug substances)
Accelerated 40℃ ± 2℃/ 75% RH±
5% RH
40°C ± 2°C / 75% RH ±
5% RH
6 months
Intermediate - 30°C ± 2°C / 65% RH ±
5% RH
6 months (if applicable as per ICH)
32. 3.2.P.8.2 Post-
approval Stability
Protocol and
Commitment
At least one batch per year of API
manufactured at each commercial
site (unless none is produced that
year) should be added to the
continuing stability monitoring
program.
If stability data on Primary
batches is submitted, a
commitment to place the first two
(GCC)/three (HC) production
batches on long-term stability
studies through the proposed
retest period should be provided.
GCC Guidelines Health Canada
a. Number of batch(s) and
different batch sizes
b. Relevant physical, chemical,
microbiological and biological
test methods;
c. Acceptance criteria;
d. Reference to test methods;
e. Description of the container
closure system(s);
f. Testing frequency;
g. Description of the conditions
of storage
a. Number of batches and
batch sizes;
b. Tests and acceptance
criteria;
c. Container closure
system(s);
d. Testing frequency; and
e. Storage conditions (and
tolerances) of samples.
Minimum requirements:
33. 3.2.P.8.3
Stability Data
GCC Guidelines Health Canada
• Results to be provided in tabular
format. Separate table for each batch.
• Results to be provided in
tabular, graphical, or narrative.
• Actual numerical results should be
provided. Vague statements -“within
limits” or “conforms” shall not be
mentioned.
• Actual numerical results should
be provided. Vague statements
-“within limits” or “conforms”
shall not be mentioned.
• If significant change observed between
three and six months’ testing at
accelerated storage condition, re-test
period to be proposed based at long-
term storage condition.
• If significant change observed
between three and six months’
testing at accelerated storage
condition, intermediate
condition testing
recommended.
• - • Impurities observed above the
reporting threshold should be
reported and identified by
name if known, or by retention
time or applicable code if
unknown.
34. 3.2. A Appendices
3.2.A.1 Facilities
and Equipment
3.2.A.2
Adventitious
Agents Safety
Evaluation
3.2.A.3 Excipients
35. 3.2.R Regional
Information
3.2. R UAE CANADA
3.2.R.1 Alcohol Content
Declaration
PRODUCTION
DOCUMENTATION
R.1.1 Executed
Production Documents
R.1.2 Master
Production Documents
(MPDs)
3.2.R.2 Porcine/Pork-
content/origin
Medical devices
3.2.R.3 The diluents and
colouring agents
in the product
formula
Acceptable
compendial
monographs
37. Different
Scenarios-UAE
How to submit the information in Quality module if a drug
product contains more than one drug substance?
one complete “3.2.S” section should be provided for one
drug substance, followed by other complete “3.2.S” sections
for each drug substance.
For a drug product with multiple strengths:
one complete “3.2.P” section should be provided with the
information for the different strengths provided within the
subsections. One complete copy of the dossier should be
provided for each strength.
For a drug substance from multiple manufacturers:
one complete “3.2.S” section should be provided for the
drug substance from one manufacturer, followed by other
complete “3.2.S” sections for each drug substance
manufacturer.
38. Different
Scenarios-UAE
For a drug product with multiple container closure
systems (e.g. bottles and unit dose blisters):
one complete “3.2.P” section should be provided with the
information for the different presentations provided within
the subsections.
For multiple drug products (e.g. tablets and a parenteral
product):
A separate dossier is required for each drug product.
For a drug product supplied with reconstitution diluent(s):
the information on the diluent should be provided in a
separate part “3.2.P” if the diluent is co-packaged with the
drug product.
if the diluent is not co-packaged with the drug product, the
compatibility of the diluent with the drug product should be
discussed in 3.2.P.2.6.
39. References:
Registration of a Conventional Pharmaceutical Product E-CTD Requirements-UAE.
GCC Guidelines for Stability Testing of API & FPP
The GCC Data Requirements for Human Drugs Submission.
GUIDANCE DOCUMENT:Quality (Chemistry and Manufacturing) Guidance: New Drug
Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)-Health Products
and Food Branch-Canada.
WHO good manufacturing practices for sterile pharmaceutical products-Annex 6