Introduction To Good Manufacturing Practice (GMP)

intro to GMP online training

Duration :


1 hour(s)

Skill level:




Final exam:


Certificate of Completion:


CEU / CPD Accreditation:



Successful completion provides learners with a dated, traceable and downloadable certificate for the course : 

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.


The quality of pharmaceutical products is subject to a lot of scrutiny and meticulousness regarding quality because anything less than the best possible quality will result in financial losses and regulatory issues for companies. Good Manufacturing Practice (GMP) is a set of guidelines used to ensure consistency in the manufacture of quality healthcare products. These guidelines cut across the different facets and departments involved in the manufacturing process including sourcing for and purchasing raw materials, training personnel, validating and monitoring systems, and documentation. This course provides a detailed introduction to the concept, helping participants. understand why some regulations are in place. You will also learn about the roles of the WHO and other regulatory agencies in enforcing GMP.


In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.





Introduction: Good Manufacturing Practice (GMP): Definitions and Scope


  • Definition
  • Why is GMP important?
  • What is GMP?


Lesson 1: Importance Of Organization and Personnel in GMP


  • Introduction
  • Personnel: Qualifications and Experience
  • Personnel Training
  • Personal Hygiene and Health
  • Personal Responsibility
  • Consultants


Lesson 2: Buildings, Surroundings, and Facilities


  • Ancillary Areas
  • Storage Areas
  • Weighing Areas
  • Production Areas
  • Quality Control Areas


Lesson 3: Equipment


  • Introduction
  • Design, Size, Location, and Construction of Equipment
  • Design
  • Size
  • Location
  • Construction
  • Equipment Identification
  • Equipment Log
  • Cleaning and Maintenance of Equipment


Lesson 4: Materials Management System


  • Introduction
  • Purchasing
  • Raw Materials
  • Package Materials



Lesson 5: Quality Management System



Lesson 6: Manufacturing Operations and Control

  • Identity
  • Strength
  • Safety


Lesson 7: Documentation and Records

  • Steps in Total PMD Program
  • Guidelines for Designing and Implementing PMD Program
  • Definition of Documentation
  • Objectives of Documentation
  • Importance of Documentation
  • Preparation, Issue, and Use of Documents
  • Product Traceability
  • Storage and Retention of Documents and Records
  • Storage and Retrieval of Documents
  • Disposal of Document


Lesson 8: Pharmaceutical Validation


  • Introduction
  • Scope of Validation
  • Analytical Test Method
  • Instrument Calibration
  • Process Utility Services
  • Raw Materials and Packaging Materials
  • Equipment
  • Facilities
  • Product Design
  • Cleaning
  • Operators
  • Importance of Validation
  • Reduction of Quality Costs
  • Preventive Costs
  • Appraisal Costs
  • Internal Failure Costs
  • External Failure Costs
  • Process Optimization
  • Assurance of Quality
  • Safety
  • Limitations of Validation



Lesson 9: Outsourcing


  • Introduction
  • Manufacturing and Packaging Outsourcing
  • Contract Giver
  • Contract Acceptor
  • The Contract
  • Analytical Outsourcing
  • Other Services Outsourcing



Lesson 10: Post Operational Activities


  • Introduction
  • Distribution
  • Recalled Products
  • Returned Products
  • Complaints and Adverse Events
  • Adverse Events
  • Drug Product Salvaging


Lesson 11: Site and Plant Security


  • Introduction
  • Security Personnel
  • Security Manager
  • Security Staff
  • Entry to Site
  • Entry to Plant Buildings
  • Internal Security
  • Current Issues


Lesson 12: Pharmaceutical Audits


  • Introduction
  • Internal Audits
  • External Audits
  • Regulatory Audits
  • Designing of Internal Audit System
  • Implementing Internal Audit System
  • How Should the Department Prepare for the Audit?



Lesson 13: Safety and Environmental Protection


  • Introduction
  • Safety
  • Environmental Protection and Procedures








Ellena Jefferson
Dr. Ellena J. Jefferson
Dr. Jefferson is a CAPA Manager at Janssen Pharmaceuticals where she serves as a Training and Quality Advisor with ICONIC plc, a global provider for consulting and outsource development in the pharmaceutical industry. She holds a Masters of Science in Research Administration, Magna Cum Laude from the University of Central Florida. Dr. Jefferson is a fixer who continuously strives for excellence as a way of life; not just as a job.


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