Good Manufacturing Practices (Gmp) Knowledge

Pharmaceutical

What you'll learn

Understand the importance of proper personnel and material flows, as well as how to design and manage laboratory and production environments to prevent risks

Understand and apply the fundamental principles of Good Manufacturing Practices in your daily operations.

Have a deeper awareness of how to maintain product quality, prevent contamination and mix-ups, and ensure the integrity of all documentation

Proficient in documenting and handling data, ensuring accuracy and traceability in compliance with the ALCOA principles.

Requirements

The course is for student or professional in the pharmaceutical field in order to learn or improve their skills.

Description

In this course, we will provide a comprehensive introduction to Good Manufacturing Practices (GMP) in the pharmaceutical industry. Whether you're new to GMP or looking to refresh your knowledge, this course will guide you through the critical principles and best practices that ensure high-quality, compliant manufacturing processes.We will begin by exploring the origins of GMP, its creation, and the objectives it seeks to achieve. You will learn why GMP standards are essential for maintaining product safety and quality in the pharmaceutical industry. Following that, we will dive into the importance of personnel within a pharmaceutical company, focusing on the role of each individual in maintaining high GMP standards. A key part of this will be understanding the difference between contamination and mix-ups—two issues often confused—and how to effectively prevent and control both in a GMP-compliant environment.Next, we’ll examine the expectations for health, dressing, and behavior according to GMP guidelines. This includes understanding personal hygiene, appropriate attire, and workplace conduct, all critical to maintaining a sterile and safe environment. We’ll then discuss the management of personnel and materials within the facility, covering best practices to ensure efficiency and prevent contamination risks.The course will also cover GMP requirements for equipment design, cleanliness, and maintenance, emphasizing the importance of equipment validation and preventive maintenance. Afterward, we will explore GMP standards for the Quality Control Laboratory, focusing on how contamination and mix-ups can occur in a lab setting and the distinct consequences of these issues in comparison to production environments.Finally, we’ll address the importance of proper documentation and record-keeping within GMP compliance. We will focus on Data Integrity, explaining how to ensure accurate and compliant records across all stages of the manufacturing process.This course is ideal for pharmaceutical industry professionals seeking a deeper understanding of GMP, quality assurance, and regulatory affairs professionals, as well as beginners interested in GMP compliance in regulated environments.

Overview

Section 1: Introduction

Lecture 1 Introduction

Lecture 2 Agenda

Section 2: The course

Lecture 3 GMP: Good Manufacturing Practices

Lecture 4 GMP structure

Lecture 5 GMP goals

Lecture 6 Personnel part I

Lecture 7 Personnel Part II

Lecture 8 Soft skills

Lecture 9 From theory to practise

Lecture 10 Training

Lecture 11 Contamination vs mix-up

Lecture 12 How to prevent mix-up

Lecture 13 Types of contamination

Lecture 14 Risk containment actions

Lecture 15 Health and Igiene

Lecture 16 Transition from dirty to clean areas

Lecture 17 Material flows

Lecture 18 Equipments

Lecture 19 Detergent,disinfectant, sanitizers

Lecture 20 Disinfectant effects

Lecture 21 Quality Control

Section 3: Data Integrity

Lecture 22 GMP documentation and Data Integrity

Lecture 23 ALCOA

Lecture 24 Data Integrity

Lecture 25 From theory to practise

Lecture 26 Conclusions

Quality Assurance, Quality Control or Production employee or students.