Good Manufacturing Practices (cGMP) - Advanced

21 CFR Part 211 Subpart G: Packaging and Labeling Control

This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on packaging and labeling control for drug manufacturing, processing, packing, or holding. These regulations are outlined in 21 Code of Federal Regulations (CFR) Part 211. This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on packaging and labeling control for drug manufacturing, processing, packing, or holding.

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CEU Credits: 0.1

Course Code: ELM-209

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.1

Effective Date: 09/06/2021

Curriculum for this course

Introduction

Overview

Who Should Take This Course?

Learning Objectives

Definitions

Module 1: Materials Examination and Usage Criteria (Sect. 211.122)

Written Procedures (a)

Approval or Rejection (b)

Maintenance and Storage (c)(d)(e)

Gang-Printed Labeling (f)

Special Control Procedures (g)(1-4)

Monitoring (h)

Module 2: Labeling Issuance (Sect. 211.125)(a-f)

Labeling Issuance (Sect. 211.125)(a-f)

Module 3: Packaging and Labeling Operations (Sect. 211.130)(a-e)

Packaging and Labeling Operations (Sect. 211.130)(a-e)

Module 4: Tamper-Evident Packaging Requirements for Over-the-Counter (OTC) Human Drug Products (Sect. 211.132)

General Requirements (a)

Requirements for Tamper-Evident Package (b)(1-2)

Labeling (c)(1)(i-iii)(2)

Request for Exemptions from Packaging and Labeling Requirements (d)(1-4)

OTC Drug Products Subject to Approved New Drug Applications (e)

Poison Prevention Packaging Act of 1970 (f)

Module 5: Drug Product Inspection (Sect. 211.134) (a-c)

Drug Product Inspection (Sect. 211.134) (a-c)

Module 6: Expiration Dating (Sect. 211.137) (a-h)

Expiration Dating (Sect. 211.137) (a-h)

Conclusion

Revision History

v1.1 Minor update on 01/08/2026 Quiz typo fixed. Quality number, Effective date, and IACET information added. Course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.

v1.0 Course released on 09/06/2021