Good Manufacturing Practices (GMP)

An in-depth introduction to GMP for pharmaceuticals.

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About this Course

This course provides an introduction to GMP for pharmaceuticals and the current U.S. FDA regulations. It reviews a brief history of GMP regulations and discusses the regulatory requirements for the quality management system, equipment, batch records, validation, packaging, labeling, holding, distribution, and audits.

There are many components to the GMP regulations, and this course provides a general introduction to many of these key elements. This course reviews manufacturing regulations 21 CFR 210 (Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding Drugs) and 21 CFR 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals 2021). It also discusses FDA guidance and applicable question and answer (Q&A) documents intended to assist industry.

Language Availability: English

Suggested Audiences: Distribution Staff, Labeling Staff, Other sponsor organization representatives that contract to GMP vendors and need to understand the regulations., Packaging Staff, Production and Manufacturing Technicians, Quality Professionals, Validation Staff

Organizational Subscription Price: $500 per year/per site
Independent Learner Price: $99 per person

Demo Instructions


Course Content

History and Overview of Good Manufacturing Practices (GMPs)

To best understand the Current Good Manufacturing Practice (CGMP) requirements, it is helpful to review the history and evolution of the regulations. This module covers key cases that helped form current GMPs, then reviews each section from key manufacturing regulations 21 CFR 210 and 211. It also describes the importance of the term “current” in the regulations.

Recommended Use: Required
ID (Language): 20408 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix

Requirements of the Quality System

A quality system is the foundation that allows an organization to adhere to Current Good Manufacturing Practices (CGMPs), which in turn allows it to consistently meet or exceed its customer’s specifications. This module describes the purpose and organization of a quality system in manufacturing, differentiates quality assurances and quality controls, reviews SOPs for key processes, and describes roles and responsibilities for individuals focused on quality.

Recommended Use: Required
ID (Language): 20409 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix

Personnel Requirements

Personnel are essential to the production of pharmaceuticals; without them the drug product would not be produced.  Staff must be properly trained and qualified. An organization adhering to CGMPs should clearly define, develop, demonstrate, and document all staff competencies working in the CGMP environment.

This module provides an overview of personnel requirements for CGMP. It discusses staff training, job descriptions, and qualifications. It also explores key personnel roles along with hygiene and wellness program considerations.

Recommended Use: Required
ID (Language): 20410 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix

Facility, Equipment Calibration, Maintenance, and Cleaning

A Good Manufacturing Practice (GMP) facility’s design is critical to the overall functioning of the manufacturing process. There are many different components to consider: from flow of staff and equipment, to the water system plumbing, as well as the electrical system and lighting.  Proper environmental monitoring is also critical to continuously verify microbiological and particulate counts. The heating, ventilation, and air conditioning (HVAC) system design must also be considered to ensure adequate air flow and filtration to ensure no cross contamination occurs.

This module reviews the FDA’s GMP requirements related to facility design, HVAC controls, facility cleaning, environmental monitoring, water systems, validation master plans, equipment and instrument calibration and maintenance, and cleaning programs and cleaning validation.

Recommended Use: Required
ID (Language): 20411 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix

Validation

There are specific regulatory requirements for the validation of software, processes, and analytical methods used in manufacturing. In this module, we will explore the procedures for software validation, process validation, and analytical method validation according to Current Good Manufacturing Practices (CGMPs). This module also reviews key regulations and requirements for validation and pitfalls to avoid.

Recommended Use: Required
ID (Language): 20412 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix

Batch Records and Other Documentation

Batch production records (also known as batch records) provide step-by-step instructions on how to manufacture a product, while also collecting the detailed information for the specific lot being made. A batch is synonymous with the lot produced.  There are many important parameters involved when making a batch following Current Good Manufacturing Practices (CGMPs). Each step is important and must be followed as prescribed.  Sampling instructions, time limits, and other sequences are typical of the detailed instructions captured within a batch record.  Once the batch is complete the quality unit reviews all the documentation to verify the product meets the pre-approved specifications and was manufactured according to the CGMPs.  Many documents and other records support the batch record and are reviewed and approved by the quality unit to release a product.

This module reviews the purposes and key components of batch records, and the associated CGMPs’ documentation requirements. The module concludes with a discussion on good documentation practices and document storage.

Recommended Use: Required
ID (Language): 20413 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix

Packaging, Labeling, Storage, and Distribution of Product

After manufacturing, the regulations require proper packaging, labeling, storage, and distribution of the drug product or substance. Standard operating procedures are necessary to define the operations and quality control parameters essential to maintain a state of control. Clear documentation within the batch record will assure regulatory agencies (such as the FDA) that regulatory requirements were upheld during the manufacturing process.

In this module, we examine the GMP requirements and procedures for packaging, labeling, storage, and distribution processes. The module highlights the required standard operating procedures, reviews typical FDA inspectional observations to avoid, and reviews requirements for stability testing and expiration dating.

Recommended Use: Required
ID (Language): 20414 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix

Audits and Inspections

Audits and inspections are a essential elements of the quality system. While being audited or inspected can create anxiety, it also promotes assurance that an organization adhering to current GMP regulations is following the regulations and procedures.

This module describes the purpose of an internal audit program and differentiates internal audits from external audits and inspections. It focuses on the various types of quality audits used in the GMP environment. It also discusses mock inspections and what an inspection preparedness program should include.

Recommended Use: Required
ID (Language): 20415 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix


FAQs

Who should take the Introduction to Good Manufacturing Practices course?

This course is designed for quality professionals; production and manufacturing technicians; packaging, distribution, and labeling staff; validation staff; and, any other sponsor organization representative that contract to GMP vendors and needs to understand the regulations. This course is also for any other staff looking to enter the GMP sector.

This course is an introduction to GMPs, so no previous experience with GMP is required prior to taking the course.

Which regulations does this course cover?

This course covers the key elements of the U.S. Food and Drug Administration (FDA) regulations for good manufacturing practices at 21 CFR 210 and 211.

How long does it take to complete the Introduction to Good Manufacturing Practices course?

This course consists of eight modules. Each module contains detailed content and quiz as well as images, supplemental materials, and case studies (when appropriate).

Modules vary in length, and learners may require different amounts of time to complete them based on their familiarity and knowledge of the topic. However, modules are each designed to take about 30 minutes to complete.

Is this course eligible for continuing medical education credits?

This course does not currently have CE/CME credits available.

What are the standard recommendations for learner groups?

This course is designed to be completed in its entirety and sequentially. A recommendation is to set all modules as “Required” for initial completion.