Susan Marshall, P.E., BSChE, MBA

Course Outline

This course provides an introduction to the FDA Current Good Manufacturing Practices (CGMPs) for Pharmaceuticals.  CGMPs are the foundation for producing drugs and medicines in a manner compliant with the FDA requirements.  CGMPs, also called “Part 210 & 211”, are the mandatory requirements for manufacturing any product identified as a drug. 

This course includes a multiple choice quiz at the end, which is designed to enhance the understanding of the course materials.

Learning Objective

At the conclusion of this course, the student will:

• Be aware of the FDA CGMPs for pharmaceuticals;
• Understand the overall intent of the FDA CGMPs for pharmaceuticals;
• Learn the definition of a drug;
• Learn the contents of the general pharmaceutical CGMPs, 21 CFR Part 210;
• Learn the 11 subparts of the pharmaceutical CGMPs, 21 CFR Part 211;
• Be familiar with where to find the CGMPs at www.fda.gov;
• Learn the CGMP requirements for Buildings & Facilities, Equipment, and Production;
• Learn the CGMP requirements for Packaging, Label Control, Warehousing, and Distribution; and
• Understand the criticality of records and documentation.

Intended Audience

This course in intended for chemical engineers, process engineers, mechanical engineers, facility & utility engineers, maintenance engineers, safety engineers, quality engineers, validation engineers, and management responsible for any part of the manufacturing of drug or medicinal products, including buildings, facilities, utilities, maintenance, raw materials, packaging, labeling, warehousing, storing, testing, and distribution.

Benefit to Attendees

Attendees of this course will be introduced to the Part 210 & 211 CGMPs pertinent to the manufacturing of drug, medicinal, and pharmaceutical products.

Course Introduction

The FDA has defined the mandatory requirements for manufacturing drug and pharmaceutical products in 21 CFR Part 210 & 211, which are called “Current Good Manufacturing Practices (CGMPs) for Pharmaceuticals”. These requirements are intended for the manufacturers to prove their drug products perform as intended and are safe for patients.  The CGMPs are available to everyone and can be found at www.fda.gov. Despite the title, CGMPs reach far beyond the manufacturing or production floor.  CGMPs contain requirements for buildings, facilities, equipment, packaging, labeling, warehousing, storage, raw materials, distribution, laboratory controls, and more.  Documented evidence and detailed records are required as proof the drug products are being manufactured in compliance with CGMPs.

Course Content

The course content is in a PDF file:

Introduction to the FDA Current Good Manufacturing Practices (CGMPs) for Pharmaceuticals

Please click on the above underlined hypertext to view, download or print the document for your study. Because of the large file size, we recommend that you first save the file to your computer by right clicking the mouse and choosing "Save Target As ...", and then open the file in Adobe Acrobat Reader. If you still experience any difficulty in downloading or opening this file, you may need to close some applications or reboot your computer to free up some memory.

Course Summary

The FDA’s requirements for “Current Good Manufacturing Practices for Pharmaceuticals” (CGMPs) have requirements far beyond the manufacturing floor.  CGMPs contain requirements for buildings, facilities, equipment, packaging, labeling, warehousing, storage, raw materials, distribution, laboratory controls, and more.  Documented evidence and detailed records are required are the foundation of proving the drug products are being manufactured in compliance with CGMPs.

Related Links

Facts About FDA Current Good Manufacturing Practices (CGMP)
https://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm169105.htm

21 CFR Part 210
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=210.1

21 CFR Part 211
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211

Quiz

Once you finish studying the above course content, you need to take a quiz to obtain the PDH credits.