The document discusses guidelines for supplemental new drug applications (sNDAs) according to the US FDA. It outlines three categories of variations - major, moderate, and minor - based on their potential impact. Major changes require prior approval and could impact safety or efficacy. Moderate changes require submission 30 days before distribution or upon FDA receipt. Minor changes only require description in the annual report. The document provides examples of changes in manufacturing sites, processes, specifications, container closure systems, and labeling that would fall under each category. Close monitoring and reporting of any post-approval changes is recommended to ensure the quality, safety and efficacy of pre-qualified products are not adversely affected.
This document discusses out of specification (OOS) results and the processes for investigating them. It covers:
1) What OOS is and when investigations are conducted.
2) The initial laboratory investigation and the responsibilities of the analyst and supervisor.
3) Full-scale investigations which include reviewing manufacturing, production, sampling, and initial lab results.
4) Supplementary laboratory testing like re-testing and re-sampling to identify the source of errors.
5) Analyzing the investigated results to determine the possible causes of OOS results.
This document discusses quality risk management (QRM) in the pharmaceutical industry. It begins by introducing QRM and its importance in ensuring quality systems. The document then outlines the scope of QRM, including its application across various stages of drug development and manufacturing. The core principles and process of QRM are described, including risk assessment, control, communication, and review. Various risk management tools are also introduced. Finally, the document discusses integrating QRM into industry and regulatory operations to facilitate consistent decision making.
The Center for Drug Evaluation and Research (CDER) is responsible for protecting and promoting public health by ensuring the safety and effectiveness of human drugs. CDER oversees new drug development and reviews marketing applications, monitors drug safety after approval, and ensures quality in manufacturing. CDER's mission is to ensure that drugs are safe and effective for their intended use through activities like reviewing new drug applications, communicating drug information to health professionals and consumers, and facilitating innovation in drug development.
The document summarizes the requirements and process for submitting a New Drug Application (NDA) to the U.S. FDA for approval to market a new drug product. An NDA must provide extensive documentation about the drug's safety and efficacy established through clinical and non-clinical trials, as well as details on manufacturing processes and quality controls. The application contains multiple technical sections that thoroughly describe the drug's chemistry, manufacturing, pharmacology, clinical data and results. If approved, the NDA permits legal marketing of the new drug in the United States.
This document discusses change control in the pharmaceutical industry. It begins by defining change control as a formal system to review proposed or actual changes that could affect facilities, systems, equipment, or processes. The functions of change control are then outlined as identifying, reviewing, approving, validating, analyzing, and monitoring changes. The areas of change that would require control are described, including manufacturing, quality control, research and development, engineering, and marketing. Finally, the document states that written procedures and documentation like standard operating procedures and change control forms are necessary parts of the change control system.
The document discusses the European Medicines Agency (EMEA), which is responsible for evaluating and supervising medicines in the European Union. It describes the various committees within EMEA, including the Committee for Medicinal Products for Human Use (CHMP) which authorizes medicines, the Committee for Orphan Medicinal Products (COMP) which designates orphan drugs for rare diseases, and others focused on veterinary medicines, herbal medicines, and pharmaceutical regulation. The EMEA ensures that authorized medicines meet quality, safety, and efficacy standards and monitors medicines once they reach the market.
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
The document discusses guidelines for supplemental new drug applications (sNDAs) according to the US FDA. It outlines three categories of variations - major, moderate, and minor - based on their potential impact. Major changes require prior approval and could impact safety or efficacy. Moderate changes require submission 30 days before distribution or upon FDA receipt. Minor changes only require description in the annual report. The document provides examples of changes in manufacturing sites, processes, specifications, container closure systems, and labeling that would fall under each category. Close monitoring and reporting of any post-approval changes is recommended to ensure the quality, safety and efficacy of pre-qualified products are not adversely affected.
This document discusses out of specification (OOS) results and the processes for investigating them. It covers:
1) What OOS is and when investigations are conducted.
2) The initial laboratory investigation and the responsibilities of the analyst and supervisor.
3) Full-scale investigations which include reviewing manufacturing, production, sampling, and initial lab results.
4) Supplementary laboratory testing like re-testing and re-sampling to identify the source of errors.
5) Analyzing the investigated results to determine the possible causes of OOS results.
This document discusses quality risk management (QRM) in the pharmaceutical industry. It begins by introducing QRM and its importance in ensuring quality systems. The document then outlines the scope of QRM, including its application across various stages of drug development and manufacturing. The core principles and process of QRM are described, including risk assessment, control, communication, and review. Various risk management tools are also introduced. Finally, the document discusses integrating QRM into industry and regulatory operations to facilitate consistent decision making.
The Center for Drug Evaluation and Research (CDER) is responsible for protecting and promoting public health by ensuring the safety and effectiveness of human drugs. CDER oversees new drug development and reviews marketing applications, monitors drug safety after approval, and ensures quality in manufacturing. CDER's mission is to ensure that drugs are safe and effective for their intended use through activities like reviewing new drug applications, communicating drug information to health professionals and consumers, and facilitating innovation in drug development.
The document summarizes the requirements and process for submitting a New Drug Application (NDA) to the U.S. FDA for approval to market a new drug product. An NDA must provide extensive documentation about the drug's safety and efficacy established through clinical and non-clinical trials, as well as details on manufacturing processes and quality controls. The application contains multiple technical sections that thoroughly describe the drug's chemistry, manufacturing, pharmacology, clinical data and results. If approved, the NDA permits legal marketing of the new drug in the United States.
This document discusses change control in the pharmaceutical industry. It begins by defining change control as a formal system to review proposed or actual changes that could affect facilities, systems, equipment, or processes. The functions of change control are then outlined as identifying, reviewing, approving, validating, analyzing, and monitoring changes. The areas of change that would require control are described, including manufacturing, quality control, research and development, engineering, and marketing. Finally, the document states that written procedures and documentation like standard operating procedures and change control forms are necessary parts of the change control system.
The document discusses the European Medicines Agency (EMEA), which is responsible for evaluating and supervising medicines in the European Union. It describes the various committees within EMEA, including the Committee for Medicinal Products for Human Use (CHMP) which authorizes medicines, the Committee for Orphan Medicinal Products (COMP) which designates orphan drugs for rare diseases, and others focused on veterinary medicines, herbal medicines, and pharmaceutical regulation. The EMEA ensures that authorized medicines meet quality, safety, and efficacy standards and monitors medicines once they reach the market.
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
The document provides guidelines for handling out of specification test results as outlined by the USFDA. It defines an out of specification result as one that falls outside the defined test limits. It discusses the USFDA's OOS guidelines published in 2006 and notes that quality units should have a defined SOP for addressing OOS results. The SOP scope should be well defined and investigations into OOS results should be thorough, timely, unbiased, well documented, and scientifically sound. Laboratory investigations should check for errors and, if none are found, a phase II investigation including retesting and investigation at the plant may be initiated. Tools like 5M, 5 whys, DMAIC and root cause analysis should be used to identify
Approval and Application Process involved in Investigational New Drug (IND)Nipun Gupta
1. Introduction
During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
2. Drug development team
3. Investigational new drug application (INDA)
4. Format and content of IND
5. Preclinical testing
6. The development process IND
application and safety
7. Clinical research
8. New drug application
9. Abbreviated new drug application
10. Changes to an approved NDA or ANDA
11. Difference between NDA and ANDA
The document discusses the requirements and contents of an Investigational Medicinal Product Dossier (IMPD) which provides information on the quality, manufacture, and control of investigational medical products (IMPs) used in clinical trials in the European Union. An IMPD includes summaries of nonclinical and clinical data and is required for authorization to perform clinical trials in EU member states. It must provide an overall risk-benefit assessment of the proposed trial based on nonclinical and clinical analyses. A simplified IMPD may be acceptable in some cases such as if the IMP is already authorized. The IMPD covers quality data, nonclinical pharmacology and toxicology data, previous clinical experience, and an overall risk assessment.
ICH Q10 provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes a quality management system for the pharmaceutical industry. The objectives of the Q10 model are to achieve product realization, establish and maintain a state of control, and facilitate continual improvement. ICH Q10 covers pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. It is intended to enhance existing good manufacturing practice requirements and be used together with them.
This document discusses in-process quality control (IPQC) tests for ointments. It describes IPQC as the process of controlling quality parameters during manufacturing from raw materials to final packaging. It then lists and describes 11 common IPQC tests conducted on ointments, including tests for appearance, drug content, pH, sensitivity, spreadability, absorption rate, extrudability, sterility, viscosity, medicament release rate, and uniformity of weight. The tests are designed to ensure the quality, safety and efficacy of ointment products during production.
This document discusses supplemental new drug applications (SNDA) which are submitted to the FDA for approval of changes to approved drugs. It defines what types of changes require an SNDA, including manufacturing changes, formulation changes, and labeling changes. It categorizes changes as major, moderate, or minor based on their potential impact on quality, safety, or efficacy. Major changes require prior approval, moderate changes require 30 days' notice, and minor changes are reported annually. Examples are provided for each category of change.
This document provides an overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It defines ICH as a program involving regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration. The document outlines ICH's objectives, members, structure, guidelines, and quality guidelines related to good manufacturing practices, specifications, analytical validation, stability testing, and impurities.
The document discusses electronic common technical document (eCTD), which is the electronic equivalent of the common technical document for submitting regulatory information to health authorities. It describes what eCTD is, why it is used, its history and adoption by different regions. It also explains the modules, components and general considerations for compiling an eCTD submission. Specific requirements for submitting to the EU and US are provided. Challenges of implementing eCTD include the need for tools, training and adapting to changes in the submission process.
The document provides information about abbreviated new drug applications (ANDAs), which are designed to allow approval of generic drug products that are equivalent to already approved brand name drugs. An ANDA must show a generic drug is comparable to the reference drug in dosage form, strength, quality and performance. It does not require preclinical and clinical trials but must demonstrate bioequivalence through bioavailability and bioequivalence studies. The ANDA contents and review process are outlined according to the Common Technical Document format in five quality, nonclinical, and clinical modules.
This document provides guidelines for developing specifications for new drug substances and products according to ICH Q6A. It discusses universal and specific tests/criteria that should be included for drug substances and products, such as identification, description, assay, impurities, dissolution, disintegration, content uniformity, and microbial limits. The document gives acceptance criteria and justification for key tests like dissolution, discussing how to set Q values and limits based on biobatch results and BCS classification. It also provides guidance on other tests for oral liquids, parenterals and solid dosage forms.
This document discusses various quality control and documentation procedures in the pharmaceutical industry. It includes 3 key points:
1. It discusses the importance of documentation in defining specifications, methods, providing an audit trail and ensuring authorized personnel have necessary information. This includes documents like specifications, batch production records, SOPs etc.
2. It describes procedures for developing key documents like master formulas, batch manufacturing records, audit plans and reports. This ensures uniform processes and allows tracing of batch history.
3. It discusses quality audits which systematically examine if quality activities comply with arrangements and objectives. This includes internal audits as well as those imposed by regulators or customers.
PIC/S is a combine term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries
harmonized relation among regulatory authorities and governments
members
history
role
objective and function
guidlines
This document provides an overview of quality risk management. It defines key terms like risk, hazard, risk assessment, and risk management. It describes the ICH guidelines related to quality risk management and explains the scope, principles, flow chart, and tools of quality risk management. The tools discussed include FMEA, FMECA, FTA, HACCP, and basic risk management methods. The document aims to introduce the topic of quality risk management.
- The document presents information on the New Drug Application (NDA) process required by the FDA to obtain approval to market a new drug product in the United States.
- An NDA provides extensive data from non-clinical and clinical studies to establish the safety, efficacy, and appropriate labeling of the drug. It includes chemistry, manufacturing, and controls information as well as clinical data from Phase I-III trials.
- The goals of an NDA are to determine if the drug's benefits outweigh its risks, if its proposed labeling is appropriate, and if the methods used to manufacture and ensure the drug's quality are adequate.
D&C Act 1940 Schedule Y - A Presentation by Akshay AnandAkshay Anand
The document discusses the Drugs and Cosmetics Act of 1940 and Rules of 1945, specifically Schedule Y which governs new drugs. It covers the history of the act, introduction to Schedule Y, rules that govern drugs listed in Schedule Y, and steps involved in the process. The conclusion thanks the reader.
The document discusses the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH aims to harmonize regulations for pharmaceutical drug development and registration among regions to ensure safety and efficiency. It provides guidelines on topics like carcinogenicity testing, genotoxicity testing, and toxicokinetics. The ICH involves regulatory authorities and the pharmaceutical industry from the European Union, Japan, and the United States who work together to establish common technical guidelines.
An out of specification (OOS) occurs when analytical results fall outside established specification ranges. There are guidelines from organizations like MHRA, CDER, and PIC/S for handling OOS events. OOS can occur during stability studies, finished products, or raw materials due to laboratory errors, process issues, or sample homogeneity problems. Investigations follow a phased approach starting with the quality control laboratory and then involving manufacturing operations if needed. The fate of an OOS batch may include reprocessing, reworking, or destruction depending on the investigation conclusions.
This document provides an overview of the new drug application (NDA) process for obtaining approval to market a new pharmaceutical drug in the United States. It describes the history of NDAs, the application requirements, FDA review process, possible outcomes, and an example of a drug that was initially not approved but later was approved after further use and review in other countries. The overall purpose of the NDA process is to ensure new drugs meet standards of safety and effectiveness before being approved for use and sale.
This document provides information about Investigational New Drug (IND) applications submitted to the FDA to request permission to study an unapproved drug in clinical trials. It discusses the types of INDs (investigational use, emergency use, treatment use), contents required in an IND submission, and circumstances where an IND is or is not required. The key purposes of an IND are to provide safety data from animal studies to begin human trials and to describe the initial proposed clinical study for FDA review before starting research.
Guidance for industry for IND applicationBharat Kumar
This document provides guidance on submitting an Investigational New Drug (IND) application to the FDA to request permission to begin human testing. It discusses the different types of INDs, including commercial, research, emergency use, and more. The document outlines the key components of an IND application, including preclinical data, manufacturing information, clinical protocols, regulations that apply, and ongoing reporting requirements like annual reports. It also discusses the IND review process, including clinical holds, amendments, and withdrawal of an IND. The overall purpose is to ensure the safety of human subjects and that the investigational product is reasonably safe to begin initial human testing.
The document provides guidelines for handling out of specification test results as outlined by the USFDA. It defines an out of specification result as one that falls outside the defined test limits. It discusses the USFDA's OOS guidelines published in 2006 and notes that quality units should have a defined SOP for addressing OOS results. The SOP scope should be well defined and investigations into OOS results should be thorough, timely, unbiased, well documented, and scientifically sound. Laboratory investigations should check for errors and, if none are found, a phase II investigation including retesting and investigation at the plant may be initiated. Tools like 5M, 5 whys, DMAIC and root cause analysis should be used to identify
Approval and Application Process involved in Investigational New Drug (IND)Nipun Gupta
1. Introduction
During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
2. Drug development team
3. Investigational new drug application (INDA)
4. Format and content of IND
5. Preclinical testing
6. The development process IND
application and safety
7. Clinical research
8. New drug application
9. Abbreviated new drug application
10. Changes to an approved NDA or ANDA
11. Difference between NDA and ANDA
The document discusses the requirements and contents of an Investigational Medicinal Product Dossier (IMPD) which provides information on the quality, manufacture, and control of investigational medical products (IMPs) used in clinical trials in the European Union. An IMPD includes summaries of nonclinical and clinical data and is required for authorization to perform clinical trials in EU member states. It must provide an overall risk-benefit assessment of the proposed trial based on nonclinical and clinical analyses. A simplified IMPD may be acceptable in some cases such as if the IMP is already authorized. The IMPD covers quality data, nonclinical pharmacology and toxicology data, previous clinical experience, and an overall risk assessment.
ICH Q10 provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes a quality management system for the pharmaceutical industry. The objectives of the Q10 model are to achieve product realization, establish and maintain a state of control, and facilitate continual improvement. ICH Q10 covers pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. It is intended to enhance existing good manufacturing practice requirements and be used together with them.
This document discusses in-process quality control (IPQC) tests for ointments. It describes IPQC as the process of controlling quality parameters during manufacturing from raw materials to final packaging. It then lists and describes 11 common IPQC tests conducted on ointments, including tests for appearance, drug content, pH, sensitivity, spreadability, absorption rate, extrudability, sterility, viscosity, medicament release rate, and uniformity of weight. The tests are designed to ensure the quality, safety and efficacy of ointment products during production.
This document discusses supplemental new drug applications (SNDA) which are submitted to the FDA for approval of changes to approved drugs. It defines what types of changes require an SNDA, including manufacturing changes, formulation changes, and labeling changes. It categorizes changes as major, moderate, or minor based on their potential impact on quality, safety, or efficacy. Major changes require prior approval, moderate changes require 30 days' notice, and minor changes are reported annually. Examples are provided for each category of change.
This document provides an overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It defines ICH as a program involving regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration. The document outlines ICH's objectives, members, structure, guidelines, and quality guidelines related to good manufacturing practices, specifications, analytical validation, stability testing, and impurities.
The document discusses electronic common technical document (eCTD), which is the electronic equivalent of the common technical document for submitting regulatory information to health authorities. It describes what eCTD is, why it is used, its history and adoption by different regions. It also explains the modules, components and general considerations for compiling an eCTD submission. Specific requirements for submitting to the EU and US are provided. Challenges of implementing eCTD include the need for tools, training and adapting to changes in the submission process.
The document provides information about abbreviated new drug applications (ANDAs), which are designed to allow approval of generic drug products that are equivalent to already approved brand name drugs. An ANDA must show a generic drug is comparable to the reference drug in dosage form, strength, quality and performance. It does not require preclinical and clinical trials but must demonstrate bioequivalence through bioavailability and bioequivalence studies. The ANDA contents and review process are outlined according to the Common Technical Document format in five quality, nonclinical, and clinical modules.
This document provides guidelines for developing specifications for new drug substances and products according to ICH Q6A. It discusses universal and specific tests/criteria that should be included for drug substances and products, such as identification, description, assay, impurities, dissolution, disintegration, content uniformity, and microbial limits. The document gives acceptance criteria and justification for key tests like dissolution, discussing how to set Q values and limits based on biobatch results and BCS classification. It also provides guidance on other tests for oral liquids, parenterals and solid dosage forms.
This document discusses various quality control and documentation procedures in the pharmaceutical industry. It includes 3 key points:
1. It discusses the importance of documentation in defining specifications, methods, providing an audit trail and ensuring authorized personnel have necessary information. This includes documents like specifications, batch production records, SOPs etc.
2. It describes procedures for developing key documents like master formulas, batch manufacturing records, audit plans and reports. This ensures uniform processes and allows tracing of batch history.
3. It discusses quality audits which systematically examine if quality activities comply with arrangements and objectives. This includes internal audits as well as those imposed by regulators or customers.
PIC/S is a combine term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries
harmonized relation among regulatory authorities and governments
members
history
role
objective and function
guidlines
This document provides an overview of quality risk management. It defines key terms like risk, hazard, risk assessment, and risk management. It describes the ICH guidelines related to quality risk management and explains the scope, principles, flow chart, and tools of quality risk management. The tools discussed include FMEA, FMECA, FTA, HACCP, and basic risk management methods. The document aims to introduce the topic of quality risk management.
- The document presents information on the New Drug Application (NDA) process required by the FDA to obtain approval to market a new drug product in the United States.
- An NDA provides extensive data from non-clinical and clinical studies to establish the safety, efficacy, and appropriate labeling of the drug. It includes chemistry, manufacturing, and controls information as well as clinical data from Phase I-III trials.
- The goals of an NDA are to determine if the drug's benefits outweigh its risks, if its proposed labeling is appropriate, and if the methods used to manufacture and ensure the drug's quality are adequate.
D&C Act 1940 Schedule Y - A Presentation by Akshay AnandAkshay Anand
The document discusses the Drugs and Cosmetics Act of 1940 and Rules of 1945, specifically Schedule Y which governs new drugs. It covers the history of the act, introduction to Schedule Y, rules that govern drugs listed in Schedule Y, and steps involved in the process. The conclusion thanks the reader.
The document discusses the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH aims to harmonize regulations for pharmaceutical drug development and registration among regions to ensure safety and efficiency. It provides guidelines on topics like carcinogenicity testing, genotoxicity testing, and toxicokinetics. The ICH involves regulatory authorities and the pharmaceutical industry from the European Union, Japan, and the United States who work together to establish common technical guidelines.
An out of specification (OOS) occurs when analytical results fall outside established specification ranges. There are guidelines from organizations like MHRA, CDER, and PIC/S for handling OOS events. OOS can occur during stability studies, finished products, or raw materials due to laboratory errors, process issues, or sample homogeneity problems. Investigations follow a phased approach starting with the quality control laboratory and then involving manufacturing operations if needed. The fate of an OOS batch may include reprocessing, reworking, or destruction depending on the investigation conclusions.
This document provides an overview of the new drug application (NDA) process for obtaining approval to market a new pharmaceutical drug in the United States. It describes the history of NDAs, the application requirements, FDA review process, possible outcomes, and an example of a drug that was initially not approved but later was approved after further use and review in other countries. The overall purpose of the NDA process is to ensure new drugs meet standards of safety and effectiveness before being approved for use and sale.
This document provides information about Investigational New Drug (IND) applications submitted to the FDA to request permission to study an unapproved drug in clinical trials. It discusses the types of INDs (investigational use, emergency use, treatment use), contents required in an IND submission, and circumstances where an IND is or is not required. The key purposes of an IND are to provide safety data from animal studies to begin human trials and to describe the initial proposed clinical study for FDA review before starting research.
Guidance for industry for IND applicationBharat Kumar
This document provides guidance on submitting an Investigational New Drug (IND) application to the FDA to request permission to begin human testing. It discusses the different types of INDs, including commercial, research, emergency use, and more. The document outlines the key components of an IND application, including preclinical data, manufacturing information, clinical protocols, regulations that apply, and ongoing reporting requirements like annual reports. It also discusses the IND review process, including clinical holds, amendments, and withdrawal of an IND. The overall purpose is to ensure the safety of human subjects and that the investigational product is reasonably safe to begin initial human testing.
The document summarizes the process for obtaining an Investigational New Drug Application (IND) from the FDA to conduct clinical trials of an experimental drug. It outlines what is included in an IND submission such as preclinical data, clinical protocols, manufacturing information, and previous human experience. It also describes the FDA review process and requirements for annual reports during the clinical trial period. The overall goal of an IND is to demonstrate an experimental drug's safety for initial testing in humans while obtaining approval to conduct clinical research.
The document discusses the key principles and requirements of an Investigational New Drug (IND) application submitted to the FDA. An IND application seeks permission to begin clinical trials of an experimental drug and must demonstrate the drug is reasonably safe for initial human use based on animal toxicology studies. The IND submission includes a general investigational plan, protocols, chemistry/manufacturing data, pharmacology/toxicology information, and an investigators brochure providing safety and efficacy data from animal studies. The FDA reviews the IND to ensure research subjects will not be subjected to unreasonable risks before allowing clinical trials to begin.
This document discusses the requirements for an investigational new drug (IND) application. An IND is required to initiate clinical trials of an unapproved drug and must contain information on animal studies, manufacturing, and clinical trial protocols. The core battery of safety pharmacology studies evaluates effects on major organ systems like the cardiovascular, central nervous, and respiratory systems. These studies are designed to identify potential adverse effects and safety risks before human clinical trials.
This document provides an overview of the Investigational New Drug (IND) application process. It discusses how an IND is required to begin clinical trials on new drugs and allows pharmaceuticals to be transported between states for research purposes. The document outlines the various stages of pre-clinical and clinical testing, including pre-clinical studies in animals to establish safety, and the three phases of human clinical trials. It provides details on the key components of an IND application, including chemistry and manufacturing information, clinical protocols, and safety data from non-clinical studies. The overall goal of an IND is to obtain permission from the FDA to begin human clinical trials by demonstrating the new drug and trial design will not place subjects at unreasonable risk.
This document provides an overview of the Investigational New Drug (IND) application process. It discusses how an IND is required to begin clinical trials on new drugs and allows pharmaceuticals to be transported between states for research purposes. The document outlines the various stages of pre-clinical and clinical testing, including pre-clinical studies in animals to establish safety, and the three phases of human clinical trials. It provides details on the key components of an IND application, including chemistry and manufacturing information, clinical protocols, and safety data from non-clinical studies. The overall goal of an IND is to obtain permission from the FDA to begin human clinical trials by demonstrating the new drug and trial design will not place subjects at unreasonable risk.
The document provides information on Investigational New Drug (IND) enabling studies and the IND application process. Some key points:
- An IND application is required to ship an experimental drug across state lines for clinical trials before marketing approval. The FDA reviews the IND for safety.
- An IND application contains information on animal studies, chemistry/manufacturing, and clinical trial protocols. It must demonstrate the drug is reasonably safe for initial human testing.
- An IND application must follow specific guidelines, including summaries of pharmacology/toxicology studies, chemistry/manufacturing details, clinical protocols, and responsibilities of investigators and sponsors. It allows the drug to enter Phase I clinical trials upon
Investigational new drug application must be submitted after discovering a new drug and before beginning of clinical trials. Here given a brief note on the topic.The topics included are types of IND, criteria for application, Information in IND application, resources for IND application, laws.regulations, policies and procedures, IND forms and instructions, IND content requirements and review of IND
The document discusses regulations for clinical trials in India. It begins by explaining that an Investigational New Drug Application (IND) provides an exemption that allows investigational drugs to be transported across state lines for clinical trials. It then describes the process of submitting an IND to the FDA, including providing animal studies data, manufacturing information, clinical protocols, and investigator information. It notes that the FDA has 30 days to review submitted INDs. Finally, it summarizes that in India, an application for clinical trials should be submitted to the DCGI along with chemistry, manufacturing, animal study data and other required documents and trial protocols, and trials can only begin after approval from the DCGI and ethics committee.
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
The document discusses an Investigational New Drug Application (IND), which is a submission to the FDA requesting permission to study an experimental drug in clinical trials. An IND provides safety data from animal studies and details of the proposed clinical trials. It includes information on the drug's chemistry, manufacturing, pharmacology and any previous human experience. The IND process allows a drug to move through preclinical and clinical testing in humans while being monitored by the FDA to ensure the protection of clinical trial subjects.
The document provides an overview of the drug development and approval process at the US Food and Drug Administration (FDA). It describes the FDA's structure and responsibilities in regulating drugs, medical devices, food, cosmetics, and other products. The key stages of drug development include drug discovery, pre-clinical testing, clinical trials (Phase I-III), and new drug application. FDA approval is required through this rigorous process to ensure safety and effectiveness before a new drug can reach consumers.
The new drug approval process involves several phases of laboratory and clinical testing that can take over a decade and cost hundreds of millions of dollars. Only about 1 in 1000 compounds that enter pre-clinical testing are approved for human testing. After pre-clinical animal testing, companies submit an Investigational New Drug (IND) application to the FDA to request permission for human clinical trials. If approved, the drug then enters three phases of clinical trials involving several hundred to thousands of human subjects to evaluate safety, efficacy, and proper dosing. If phase 3 trials are successful, companies submit a New Drug Application (NDA) to the FDA for review and potential approval allowing marketing and post-market safety surveillance.
An Investigational New Drug (IND) application is submitted to the FDA to obtain permission to begin human clinical trials of an experimental drug. The IND application includes data from previous animal studies, the chemical structure and manufacturing process of the drug, and details of the proposed clinical trials. There are different types of IND applications, including commercial INDs for drugs intended to be marketed, research INDs for scientific study of unapproved drugs, and emergency use INDs that allow use of experimental drugs in emergency situations. The FDA reviews IND applications to ensure the safety of research subjects in the proposed clinical trials.
The document discusses the process for submitting a New Drug Application (NDA) to the FDA for approval of a new pharmaceutical. It explains that an NDA contains extensive information on the drug's safety and efficacy established during clinical trials. The FDA assembles review teams to evaluate the NDA across several technical sections including chemistry, non-clinical studies, clinical data, and labeling. The review process involves determining if the application is complete and classifying it for either priority or standard review, with priority given to drugs that would significantly improve treatment options.
The document discusses the process for approval of a new drug from development through marketing. It takes 10-15 years on average and costs over $2.6 billion to get a new drug approved. Key steps include:
- Preclinical research to identify biological targets and compounds
- FDA approval to begin clinical trials in three phases involving thousands of subjects to test safety, efficacy, and dosing
- New Drug Application submission including all clinical trial data for FDA review and approval
- Post-marketing studies and generic approval after patents expire
The document discusses the Investigational New Drug (IND) application process with the FDA. An IND application allows a company to ship an experimental drug across state lines and begin clinical trials. It must include preclinical data to show the drug is safe for initial human use as well as protocols for proposed studies. The FDA reviews the IND for 30 days before clinical trials may begin to ensure subject safety. The overall goal of an IND is to facilitate testing of new drugs while protecting clinical trial participants.
The document discusses the requirements and process for submitting a New Drug Application (NDA) to the FDA for approval of a new pharmaceutical product. An NDA must demonstrate through clinical trials and other evidence that the drug is safe and effective for its intended use. It contains extensive technical information about the drug's chemistry, manufacturing, nonclinical and clinical pharmacology studies. After preclinical testing in labs and animals, companies undertake three phases of clinical trials in humans before submitting a full NDA application with all data to the FDA for review. If approved, the drug can be marketed in the US. The overall goal is to provide the FDA enough information to determine that the benefits of the drug outweigh the risks for its proposed use.
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Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
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Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
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Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
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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 lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
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. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Kat...rightmanforbloodline
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Kat...
Ind content & format of an ind application
1. IND CONTENT & FORMAT OF AN
IND APPLICATION
SANDESH KU. PATTANAIK
Regd.No.-12001898
2. • Cover sheet (FORM FDA 1571)
• Table of contents
• Introductory statement and a general investigational plan
• Investigators brochure
• Protocols
• Chemistry , manufacturing and control information
• Pharmacology and Toxicology information
• Previous human experience with the investigational drug
• Other Important Information
• Relevant Information
3. Cover sheet (FORM FDA 1571)
• A signed Form FDA 1571 is required for the submission of an IND to the FDA.
• Sponsors should complete the form, but not modify the security settings or make
other changes to the form since the approved, secured, posted form has been
tested and allows for automated processing of submissions to the Center for
Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation
and Research (CBER).
• all information is present and correct.
• application number is present and correct
• Provide the IND number if it was previously assigned. If an IND number has not
been assigned, leave the field blank.
• For IND numbers less than six digits, the IND number should be preceded using
zeros (i.e., for IND 12345enter 012345).
• For name(s) of drug (21 CFR 312.23(a)(1)(i)),list the generic name(s) and trade
name
• Provide the dosage form, the unique ingredient identifier term and code for
active substances
4. Table of contents
• A sponsor-investigator is required to provide a table of contents and should
provide pagination and tabbed breaks between sections to allow FDA
reviewers to more easily navigate the submission.
5. Introductory statement and a
general investigational plan
• The introductory statement must include the investigational drug’s name and
all of its active ingredients, pharmacologic class, structural formula (if known),
formulation of the dosage form to be used, the route of administration, and the
broad objectives of the proposed clinical trial. There also must be a brief
summary of previous human experience with the investigational drug including
any investigational and marketing experience in other countries.
• The general investigational plan must be summarize the
1. rationale supporting the proposed clinical trial
2. Purpose of the study
3. Indication to be studied
4. Types of trials to be initiated
5. Number of study subjects
6. Risks involved
6. Investigators brochure
• The purpose of the investigator’s brochure is to make particularly vital
information regarding the investigational drug available to the other
investigators involved, who may be located at different geographic locations
• A summary of the chemical, toxicological, and pharmacokinetic aspects of an
investigational drug including any information on its safety and efficacy
obtained from any prior clinical trials, and a description of any anticipated
risks, side effects, precautions, and special monitoring.
7. • It describes the objective of the study
• the trial design
• how subjects would be selected
• how the trail is to be conducted.
Protocols
8. Chemistry , manufacturing and control
information
• Determines the adequacy of methods used to
• manufacture and assay investigational
• compound
• Safety concerns
• Describe drug substances
• Method of preparation
• Reagent and solvents
• Acceptable limits and analytical methods
• ensure quality and purity of drug.
9. Pharmacology and Toxicology
information
• The sponsor-investigator must provide adequate information about the
pharmacological and toxicological studies of the investigational drug
involving lab animals or in vitro to support the sponsor-investigator’s
conclusion that it is reasonably safe to conduct the proposed clinical trial
• should include a discussion of the rationale for the investigational drug’s
intended dose, duration, schedule, and route of administration in the
proposed trial.
10. Previous human experience with the
investigational drug
• If there has been previous human experience with the investigational drug, the
sponsor investigator is required to provide a summary of this information.
• If the investigational drug has been investigated or marketed previously, either
in the United States or other countries, detailed information relevant to the
safety of the proposed trial or the trial’s rationale must be provided.
• Any published material relevant to the safety of the proposed trial or to an
assessment of the drug’s effectiveness for its proposed investigational use
should be provided
• if the drug or drug combination has not been investigated previously, then
sponsor-investigator should contact the review division.
11. Other Important Information
• In certain circumstances, a sponsor-investigator may be
required to provide:
1. Drug dependence and abuse potential: If the investigational drug is a
psychotropic substance or otherwise has abuse potential, then
information describing related clinical trials and experience as well as
any appropriate animal data must be submitted
2. Radioactive drugs : Sufficient data from animal studies or human clinical
trials must be submitted to allow a reasonable calculation of radiation-
absorbed dose to the whole body and critical organs upon
administration to human subjects
12. Relevant Information
• If a device is to be used in conjunction with the investigational drug (e.g., a
nebulizer for an inhaled drug or a pump for continuous infusion for home
use), the FDA may require under 21 CFR 312.23(a)(11) other relevant
information on the manufacturer and model of the device to be employed
and a general description of relevant conditions of use (e.g., carrier gas, flow
rate, temperature), and whether the device is FDA-approved or cleared for its
intended use in the trial.