
Developing a preliminary concept of Good Manufacturing Practices
Assessing some formal definitions, aim and advantages of complying GMPs.
Learn how GMP compliance ensures a reliable medication by defining adulteration, verifying five characteristics, validating processes, qualifying equipment, training staff, and managing deviations.
Learn how SOPs underpin GMPs by ensuring documentation and reproducible execution. Verify outcomes through records and external controls to meet quality standards.
Realizing routinely activities that help daily complying of GMPs.
Explore the negative consequences of GMP non-compliance through three real case studies, highlighting adulterated products, recalls, data integrity failures, and regulatory actions.
Trace the historical development of GMPs from early food safety failures to modern standards, including the 1906 Pure Food and Drug Act, thalidomide, and global regulatory evolution.
This is not just one more course that rehearses the Pharmaceutical Good Manufacturing Practices (GMP) guidelines: with it you will realize why it is important to implement and follow them correctly.
The course explains why GMPs must be implemented and how you can fulfill them in daily activities. Also, through case studies, it allows you to realize the negative consequences for firms and patients when GMPs are not properly followed.
Throughout 8 video classes, complementary readings (included) and quizzes at the end of each topic, you will be able to analyze, discuss and confirm the importance of warranting the five reliability characteristics of medications, from the time when the raw materials reach the warehouse up to the finished product is distributed. In addition, you will reinforce the importance of having procedures and how to generate their content effectively.
The value of this course is that it explains why GMPs ensure that medications acquire and maintain their five reliability characteristics and what to do in daily activities to prevent their adulteration.
The program includes the following topics: 1) GMPs intuitive concept; 2) Basics; 3) How complying GMPs; (4) Standard Operating Procedures; 5) Complying GMPs 'at floor'; 6) Case studies, and 7) Historical background of GMPs.