Good Manufacturing Practice

GMP refers to the Good Manufacturing Practice regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective.

GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.

GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.

GMP is also sometimes referred to as "cGMP". The "c" stands for "current," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination, mixups, and errors, which may have been first-rate 20 years ago may be less than adequate by current standards.

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Webinars Related to GMPs

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Upcoming

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Concept and Discussion Papers

1 May 2017

Regulation Handbook: 21 CFR Parts 210 (General) & 211 (Finished Pharmaceuticals) Current Good…

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iSpeak Blog Posts Related to GMPs

Featured Conferences

Special Initiative

Training Courses Related to GMPs

GMP Fundamentals: Eleven-Part Bundle Series

Obtain a 10% Savings by Purchasing All Eleven Courses Overview ISPE is presenting an eleven-part series that will focus on the fundamentals of good manufacturing practices (GMPs). The series provides an overview of the regulations pertaining to GMPs and covers topics such as: manufacturing controls, product distribution, plant hygiene, documentation practices, buildings & facilities, organizational structure, and more. This offering gives users access to all eleven modules of the series and is intended to introduce GMPs for the new pharmaceutical employee or to provide an annual refresher for… View Course

CAPA / RCA / Investigations Training Course

Coming Soon 2024 - CAPA and Continuous Improvement using Process Performance & Product Quality Monitoring (PPPQMS), are elements of the Pharmaceutical Quality System (PQS), supported by ICH Q10. By practicing effective CAPA and PPPQMS a Pharmaceutical Quality System can realize Quality Management Maturity. View Course

GMP Fundamentals: Holding & Distribution

In this course, you will learn the requirements for storing, handling, and distributing finished products to ensure they are stored properly and not contaminated or altered during transport. For a limited time, registration fees are waived for this course. Interactive Course: What to Expect CEUs are provided once you achieve an 80% passing grade and complete the evaluation. Buy Now Return to Online Learning View Course

GMP Fundamentals: Packaging & Labeling Control

In this course, you will learn how to ensure the safety and quality of pharmaceutical products using fundamental principles and best practices. During this course, you will learn about the FDA's pharmaceutical packaging and labeling guidelines. You will gain an understanding of the basics of packaging and labeling operations, including production and inspection processes, documentation, and record-keeping. Interactive Course: What to Expect CEUs are provided once you achieve an 80% passing grade and complete the evaluation. Buy Now Return to Online Learning View Course

GMP Fundamentals: Production & Process Controls

This course offers an overview of Good Manufacturing Practices (GMP) for medical product production and process control. You will learn about GMP compliance, product design and development, process validation, control systems, and quality control procedures. Regulatory requirements, including FDA and international standards, will be covered. Upon completion, you will understand the fundamental principles and practices of GMP in medical product production. Interactive Course: What to Expect CEUs are provided once you achieve an 80% passing grade and complete the evaluation. Buy Now Return to… View Course

GMP Fundamentals: Control of Excipients, Components and Drug Product Containers/Closures

In this course, you will learn about the fundamentals and importance of GMP control in the pharmaceutical industry. Good Manufacturing Practices (GMP), is critical for ensuring the quality, safety, and efficacy of pharmaceutical products. This includes controlling excipients, components, and drug product containers/closures to meet specific standards and requirements, reducing the risk of contamination, degradation, or incorrect formulation. You will gain a deeper understanding of the role of GMP control in maintaining the integrity of the supply chain, and how following GMP guidelines helps… View Course

GMP Fundamentals: Buildings and Facilities

A “GMP Facility” is a building that is used in the production of pharmaceutical and medical device products. The proper design, layout, function and control of such facilities is essential in the manufacture of pure, safe and effective pharmaceutical products. In this course, learners will focus on understanding the building layout, safety, cleanroom conditions, as well as facility sanitation and ventilation of both production and support areas. In this On Demand course (part 4 of 11), you will learn the elements of GMP Buildings & Facilities, as required by regulation. Interactive Course… View Course

GMP Fundamentals: Equipment

GMP equipment is used in the production of pharmaceutical and medical device products. The proper design, function, qualification and control of such equipment is essential in the manufacture of pure, safe and effective pharmaceutical products. In this course learners will understand equipment design, size and location, cleaning & maintenance as well as the qualifications of GMP equipment. In this On Demand course (part 5 of 11), you will learn the elements of GMP equipment, as required by regulation. Interactive Course: What to Expect CEUs are provided once you achieve an 80% passing grade… View Course

GAMP® Data Integrity 21 CFR Part 11, 2-Day Training Course

The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing data integrity issues. As a result, industry guidance and enforcement strategies are evolving. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical, biotech, and medical device business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This… View Course

Pre-Approval Inspection Readiness Training Course

This new training course on the elements necessary to ensure readiness for pre-approval inspections provides strategy and tactics towards preparation than can be customized to individual organization requirements. View Course

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Good Manufacturing Practice

Good Manufacturing Practice

Pharmaceutical Engineering Magazine Articles

CMC Requirements for New Drug Registration in Latin America

Enabling More Efficient and Effective C&Q Through GEP

AI Governance and QA Framework: AI Governance Process Design

Software as a Service: The Journey to Becoming a Life Sciences SAAS Provider

ISPE Briefs: New Edition of Good Practice Guide on Maintenance Is Available

A Beginner’s Guide to IT System Inspection Readiness

Industry 4.0 & the Future of the Pharmaceutical Industry

Breaking with Tradition: Laying the Foundation for Validation 4.0

GMP Implementation of Online Water Bioburden Analyzers

Creating Effective Standard Operating Procedures

ISPE Comments to the Annex 2 PIC/S Draft Revision

Related Guidance Documents

Active Pharmaceutical Ingredients (1)

Compounding (1)