GTPs vs. cGMPs
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The document discusses regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) established by the U.S. Food and Drug Administration (FDA) under 21 CFR Part 1271. It provides an overview of the key requirements including establishment registration and listing, donor eligibility screening, adherence to current good tissue practice standards, inspection and enforcement, and the tiered regulatory framework for HCT/Ps. It also compares the new regulations to existing cGMP and quality system regulations.
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Introduction
Definition
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Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
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2) Key aspects of the new 21 CFR Part 1271 regulations including establishment registration and listing, donor eligibility, good tissue practice standards, and inspection authorities.
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Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
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The document discusses key changes and requirements regarding the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) and the European database on medical devices (Eudamed). Some of the main points discussed include:
- Eudamed will contain integrated electronic systems for European UDI, registration of devices and economic operators, scrutiny applications, certificates, clinical investigations, vigilance, and market surveillance.
- Traceability requirements will require manufacturers, distributors, and importers to cooperate to achieve appropriate traceability levels and identify economic operators in the supply chain.
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UDI consists of a unique device identifier (UDI) made up of a device identifier (DI) and production identifier(s) (PI). The DI is a static number assigned to each product model, while the PI contains variable information like serial number or lot number. UDI is displayed both visibly and in machine-readable form on medical devices and their packaging. Requiring UDI helps reduce medical errors, simplify data integration, and improve recall effectiveness. Exemptions may apply if direct marking could impact safety, performance, or additional processing is needed for single-use devices.
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The document summarizes changes to ISO 14155:2020 for clinical investigations involving medical devices. It notes that the standard now explicitly includes post-market investigations and software devices. Key changes include expanded risk-based monitoring allowing on-site or centralized approaches, new event escalation procedures, and emphasis on risk management throughout the clinical trial process. While GCP principles are becoming more aligned between ISO 14155 and ICH-GCP, some differences remain in adverse event reporting and how product risks and training are addressed.
Good manufacturing practices (GMP)
GMP regulations are designed to minimize risks in pharmaceutical production. They provide a framework to assure safety, identity, strength, quality and potency of drug products. GMPs require controlled production and adherence to regulations under the Federal Food, Drug and Cosmetic Act. The US GMP regulations are divided into parts 210 and 211, addressing building and facilities, equipment, packaging, labeling, holding, returns, and more. GMPs help ensure drug products are manufactured and controlled using quality standards appropriate for their intended use and to prevent adulteration.
FDA Warning letter
The document defines FDA warning letters and describes the process of FDA inspections that can lead to warning letters. It explains that warning letters notify companies of violations found during inspections and investigations. Companies must promptly correct issues and FDA will check that corrections are adequate. The document also describes different types of warning letters for various regulated industries and how to browse existing warning letters on the FDA website.
Getting to know 21 cfr 210 and 211 by micah thomas with speaker notes update ...
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This is a presentation I gave to Medical Alley in 2016 as an introductory to pharmaceutical regulations, to a largely medical device audience. I have updated it as of April 2021 to include current links and information. It may be helpful for training purposes. Please feel free to download it here or contact me at LinkedIn 'Micah Thomas' for a free PowerPoint copy with speaker notes.
https://www.linkedin.com/in/micahthomas/
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2) Key aspects of the new 21 CFR Part 1271 regulations including establishment registration and listing, donor eligibility, good tissue practice standards, and inspection authorities.
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Similar to GTPs vs. cGMPs
Good Manufacturing Practices
The document outlines the key aspects of current good manufacturing practices (cGMPs) that pharmaceutical manufacturers must follow. cGMPs come from the Food, Drug and Cosmetic Act and are enforced by the FDA. They help ensure safety and quality by requiring strict control over facilities, equipment, components, packaging, labeling, and processes. Key parts of cGMP regulations address organization, buildings, equipment, materials control, production, packaging, holding, distribution, and records. Failure to comply can result in serious legal and business consequences like product recalls or plant shutdowns.
FDA 2013 Clinical Investigator Training Course: How to put together an Applic...
This document provides an overview of a presentation by Dr. Donald Fink on preparing an Investigational New Drug (IND) application for submission to the Center for Biologics Evaluation and Research (CBER) at the FDA, focusing on the requirements for the Chemistry, Manufacturing and Controls (CMC) section of the application for cellular therapy products. The presentation outlines the key information to include in the CMC section regarding manufacturing processes, product characterization, release testing, and stability testing in order to demonstrate consistent production of the cellular therapy product. Contact information is also provided for individuals at CBER who can answer regulatory questions regarding IND submissions.
USFDA GUIDLINES
The document provides an overview of the Food and Drug Administration (FDA) in the United States. It discusses that the FDA regulates food, drugs, medical devices, cosmetics and more. It outlines the various centers and offices within the FDA focused on specific areas. It also summarizes some of the key acts and laws that provide the FDA's legal authority. Finally, it discusses cGMP guidelines and regulations under 21 CFR that pharmaceutical manufacturers must follow.
Understanding FDA Requirements Medical Devices
The medical device market is experiencing explosive growth. Currently valued at $90 billion, market growth will continue to accelerate as demographics and market drivers increase their pressure for new and innovative product offerings.
Moreover, a substantial investment of time and resources is required to properly evaluate a new product idea and estimate its potential for success. So when a company executive declines a seemingly good product idea, what is probably being declined is the expense of properly evaluating the idea, and after having paid these expenses, the prospect of embarking on an expensive commercialization effort that has a 90 percent chance of failing.
Planning Clinical Trial in USA.pdf
The United States has always been and remains to be the leading place
for the conduct of clinical trials. According to Clinicaltrials.gov, the largest
clinical trials registry, 32% of registered clinical trials were conducted in
the U.S. as of May 2022 (1). Factors such as the availability of qualified
healthcare professionals, high-quality infrastructure and facilities,
cutting-edge research, an efficient regulatory system, and a high
standard of ethics and participant protection make the U.S. the leading
country for clinical trials.
Clinical trials follow extensive preclinical research to test the safety and
efficacy of a new drug, medical device, or biological in humans. They are
usually divided into three phases: phases I, II, and III which are designed
to ascertain safety, pharmacokinetics, efficacy, dosage, and adverse
events. Figure 1 shows the typical route from discovery and preclinical
studies to the post-marketing phase (phase IV).Clinical trials represent the longest and most expensive step in bringing
drugs to the market and have the highest attrition rate, only 10% of drugs
that enter phase I trials are granted marketing approval. Therefore,
clinical trials should be conducted by experts that are
well-versed with all the regulations and guidelines in a particular region to
boost the chances of drug approval.
The United States Food and Drug Administration (US FDA) is the
regulatory body that approves and oversees the conduct of clinical trials
for drugs, medical devices, and biologicals that are intended to be
marketed in the U.S and is touted to have the most stringent standards
for drug approval. The primary role of the FDA is to protect public health
by ensuring that medicinal products and devices are safe and efficacious.
Therefore, it is necessary for sponsors/investigators or contract research
organizations (CRO) that are conducting clinical trials to be familiar with
regulations and guidances that govern the conduct of clinical trials.Conducting a clinical trial in the United States requires a deep understanding of the
regulations and guidelines set by the FDA. It is important to know what is needed for a
successful clinical trial, from selecting an appropriate study site to obtaining informed
consent from participants. Additionally, it is essential to understand the requirements for data
collection and analysis, as well as how to develop an effective protocol. Clinical trial services
in USA can provide guidance on all of these aspects and more, helping you ensure that your
clinical trial meets all necessary standards
Understanding FDA Regulations
This presentation provides an overview of the FDA regulatory landscape for medical devices. It discusses the FDA structure and centers, the classification system for devices, and the approval pathways of 510(k) clearance and premarket approval. It also covers investigational devices, combination products, and user fees. The goal is to help organizations understand the FDA requirements for entering the US medical device market.
Quality regulation for biological products current and future
The document discusses current and future regulation of biological products by the Korea Food and Drug Administration (KFDA). It provides an overview of the KFDA's functions in regulating biological product quality, registration processes, relevant laws and guidelines. It also discusses specific areas like viral product control and challenges in regulating this emerging field.
FDA Regulations
The document discusses current Good Manufacturing Practices (cGMP) regulations enforced by the FDA to ensure proper design, monitoring, and control of manufacturing processes and facilities. It provides an overview of key topics including:
- What cGMPs are and why they are important to assure drug quality and purity.
- Where cGMP regulations come from, including the Federal Food, Drug, and Cosmetic Act and sections in the Code of Federal Regulations (CFR) that pertain specifically to drug and device cGMPs.
- Some examples of cGMP requirements the FDA evaluates, such as those related to quality control responsibilities and personnel qualifications, as well as examples of evidence manufacturers can provide to demonstrate compliance.
FDA Regulations and Medical Device Pathways to Market
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
FDA Regulations and Medical Device Pathways to Market
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
Avoiding Pitfalls in the Regulatory Path - MaRS Best Practices
Innovating in the life sciences and health-care sector? You can’t escape the regulators! Before you make a costly mistake, learn from the experts who have been through the process before.
Whether you’re working on a therapeutic, an in vitro diagnostic or a medical device, come find out how to identify and mitigate challenges along the path to regulatory approval.
Gcp
Thank you for the summary. Here are a few key points I noticed:
- GCP provides an international quality standard for clinical research to protect participants and ensure reliable data.
- It has evolved in response to past abuses and aims to harmonize standards across countries/regions.
- Key roles include sponsors to design/manage studies, principal investigators to oversee local research, and staff to conduct study procedures.
- Regulations like the Code of Federal Regulations codify GCP principles to facilitate compliance.
Overall this helps explain the purpose and scope of Good Clinical Practice as an important framework in clinical research. The summary effectively distills the main points from the lengthy document.
Regulatory requirement for approval of Biologics
The document is a presentation on regulatory requirements for approval of biologics submitted by Arpitha B. M. to Dr. D. Manjula. It contains an introduction, history of biologics regulation citing key events, sources and types of biologics, differences between biologics and chemical drugs, the regulatory approval process including biological license application, and references. The presentation provides an overview of biologics, their regulation and approval process in India.
FDA classify Medical Devices and how to report device problems A Systematic R...
The typical time it takes to get a device to market is 3 to 7 years, compared to 12 years for pharmaceuticals. However, there are concerns that the Food and Drug Administration's Systematic Review Writing methods may not be adequate to satisfy the required guarantees of safety and efficacy.
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FDA 2013 Clinical Investigator Training Course: FDA Structure and Mandate
FDA 2013 Clinical Investigator Training Course: FDA Structure and Mandate
Leonard Sacks, Office of Medical Policz CDER, FDA
DESIGN OF IMPLANTABLE DEVICE – UNDERSTANDING THE PREMARKET REVIEW PROCESS AN...
1) The document provides an overview of the FDA premarket review process for medical devices, with an emphasis on biocompatibility evaluation and regulations regarding device materials.
2) Key aspects of the premarket review process are outlined, including device classification and types of premarket submissions. Biocompatibility testing requirements are discussed, with tests selected based on the intended use and patient exposure to the device.
3) Recognized standards for materials and biocompatibility testing are reviewed, with the importance of evaluating the final device rather than raw materials emphasized. Useful online FDA resources are also presented.
Chap2 CTPMR, 2nd Ed. 2016
This document discusses the FDA's perspective on regulating cellular therapies. It provides the following key points:
1. The FDA regulates cellular therapies as drugs, biological products, and human cells/tissues under various regulations including cGMP, biological product regulations, labeling regulations, and HCT/P regulations.
2. Cellular therapies present challenges for development and regulation due to their complex nature involving living cells.
3. The document provides tips for navigating FDA regulations during development, including being data-driven, providing complete documentation, being informed of FDA resources, communicating with the FDA, and planning ahead.
The Rough Waters of the Regulatory Environment
A regulatory strategy is critical to the commercialization of biomedical technologies. In particular, technologies such as new drugs and medical devices have more regulatory needs, and the strategy should be considered simultaneous to a commercialization pathway.
Webinar: Reviewing Research Involving Medical Devices
Quorum Review IRB presented a live webinar in September 2014 covering the details of IRB review for medical device studies and their special considerations.
Digital Scholar Webinar: Clinicaltrials.gov Registration and Reporting Documents
Digital Scholar Webinar: Clinicaltrials.gov Registration and Reporting DocumentsSC CTSI at USC and CHLA
The document provides information about clinicaltrials.gov registration and reporting requirements. It discusses that the U.S. Department of Health and Human Services, National Institutes of Health (NIH) requires registration of applicable clinical trials on ClinicalTrials.gov. Registration must occur within 21 days of enrolling the first participant, and results must be reported within 12 months of trial completion. The document reviews the registration process, what types of trials must be registered, responsibilities of the responsible party, and penalties for noncompliance.Similar to GTPs vs. cGMPs (20)
FDA 2013 Clinical Investigator Training Course: How to put together an Applic...
FDA 2013 Clinical Investigator Training Course: How to put together an Applic...
Quality regulation for biological products current and future
Quality regulation for biological products current and future
FDA Regulations and Medical Device Pathways to Market
FDA Regulations and Medical Device Pathways to Market
FDA Regulations and Medical Device Pathways to Market
FDA Regulations and Medical Device Pathways to Market
Avoiding Pitfalls in the Regulatory Path - MaRS Best Practices
Avoiding Pitfalls in the Regulatory Path - MaRS Best Practices
FDA classify Medical Devices and how to report device problems A Systematic R...
FDA classify Medical Devices and how to report device problems A Systematic R...
FDA 2013 Clinical Investigator Training Course: FDA Structure and Mandate
FDA 2013 Clinical Investigator Training Course: FDA Structure and Mandate
DESIGN OF IMPLANTABLE DEVICE – UNDERSTANDING THE PREMARKET REVIEW PROCESS AN...
DESIGN OF IMPLANTABLE DEVICE – UNDERSTANDING THE PREMARKET REVIEW PROCESS AN...
Webinar: Reviewing Research Involving Medical Devices
Webinar: Reviewing Research Involving Medical Devices
Digital Scholar Webinar: Clinicaltrials.gov Registration and Reporting Documents
Digital Scholar Webinar: Clinicaltrials.gov Registration and Reporting Documents
GTPs vs. cGMPs
- 1. WR Tolbert & Associates Consultants to the Biopharmaceutical Industry 11483 Cypress Woods Drive San Diego, CA 92131-3535 858-693-8163 wrt@wrtolbert.com / www.wrtolbert.com
- 2. Dogs Bark, Cows Moo, Regulators Regulate... Frank Young, M.D. former FDA Commissioner
- 20. 21 CFR Part 1271
- 21. Regulatory Requirements for HCT/P’s
- 49. WRT&A
- 50. Material and Supply Flow WRT&A
- 51. WRT&A
- 52. WRT&A