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Introduction To Good Manufacturing Practice

Introduction To Good Manufacturing Practice

Description:

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.

 

Curriculum

 

 

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
  • Planned Preventive Maintenance Program (PPMP)
  • Sample Documents
  • Equipment Description List
  • SOP on Cleaning, Operation, and Maintenance of Equipment
  • SOP on Records of Calibration

 

Lesson 4: Materials Management System

 

  • Introduction
  • Purchasing
  • Raw Materials
  • Package Materials

 

 

Lesson 5: Quality Management System

 

  • Objectives of Quality Management
  • Quality Management System
  • Quality
  • Quality by Design and Product Development
  • Risk Management and Risk Assessment
  • Corrective and Preventive Action (CAPA)
  • The Quality Unit

 

Quality Control

 

Quality Assurance

 

  • Six-system Inspection Models
  • Application of Q.M.S
  • Part A: Management Responsibilities (5 subparts)
  • Part B: Resources (4 subparts)
  • Part C: Manufacturing Operations (5 subparts)
  • Part D: Evaluation Activities (6 subparts)
  • Quality Assurance
  • Quality of the product
  • Identity
  • Strength
  • Safety
  • Purity and
  • Efficacy
  • All matters/Wide-ranging concept
  • Ultimate User
  • Sum of Total Organized Arrangement
  • Responsibilities

 

 

Lesson 6: Manufacturing Operations and Control

 

  • Introduction
  • Identity
  • Strength
  • Safety
  • Purity
  • Staff
  • Sanitation of Manufacturing Premises
  • Mix-ups and Cross-contamination
  • In Pharmaceutical Manufacturing
  • Sources of Contamination and Mix-ups
  • Controlling of Contamination and Mix-ups
  • Trained People
  • Technical or Organizational Measures
  • Processing of Entering of Intermediate and Bulk Products
  • Packaging Operations
  • P.Q.C in Manufacturing and Packaging
  • For Manufacturing and Operations
  • For Packaging Operations

 

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

 

Conclusion

 

Glossary

 

Quiz

Author:

Introduction To Good Manufacturing Practice
Dr. Faheem S. Khawaja
Dr. Faheem S. Khawaja (PharmD, MS) is an E-Learning content specialist, working as a Research Manager at Prime Foundation Pakistan, with 5 years of professional experience in healthcare and academia with a research interest in pharmaceutical nanotechnology and drug delivery systems. He is a highly capable and motivated Healthcare professional with superior analytical and problem-solving skills. Faheem possesses extensive knowledge of Pharmaceuticals and their regulatory bodies, database design, and medical informatics.

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General info:

Duration :

10

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

Reviews:

GMP guidelines present a better way of ensuring the quality of final products in manufacturing. Our team now understands that it is not as much the final evaluation of these products but a commitment to the highest possible standard of operation that maintains quality.

Michelle V

-

Director of Operations

$150 $150


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Introduction To Good Manufacturing Practice

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