Good Manufacturing Practices (cGMP) - Advanced

21 CFR Part 211 Subpart C – Building and Facilities

This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on Building and Facilities for drug manufacturing, processing, packing, or holding. These regulations are outlined in 21 Code of Federal Regulations (CFR) Part 211. A link to these regulations on the FDA’s website is available in the Resources tab of this course. The purpose of this course is to present the regulations in a clear and concise manner in order to provide participants with the necessary information required to maintain the safety and efficacy of drug products.

CEU Credits: 0.1

Course Code: ELM-205

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Introduction

Overview

Who Should Take This Course?

Learning Objectives

Definitions

Module 1: Design and Construction Features (Sect. 211.42)

Space, Size and Location (a)(b)

Preventing Contamination and Mixups (c) (1 – 10)(i-vi)

Special Considerations for Penicillin (d)

Module 2: Lighting (Sect. 211.44)

Lighting (Sect. 211.44)

Module 3: Ventilation, Air Filtration, Air Heating and Cooling (Sect. 211.46)

General Requirements (a)(b)

Air Filtration Systems (c)

Special Considerations for Penicillin (d)

Module 4: Plumbing (Sect. 211.48)

Potable Water (a)

Drains (b)

Module 5: Sewage and Refuse (Sect. 211.50)

Sewage and Refuse (Sect. 211.50)

Module 6: Washing and Toilet Facilities (Sect. 211.52)

Washing and Toilet Facilities (Sect. 211.52)

Module 7: Sanitation (Sect. 211.56)

General Requirements (a)

Sanitation Procedures (b)(c)(d)

Module 8: Maintenance (Sect. 211.58)

Maintenance (Sect. 211.58)

Conclusion

Final Assessment

Certification

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP

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