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Importance of GMP Compliance Training

Written By Manisha Reddy K

Importance of GMP Compliance Training

According to World Health Organization (WHO), Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled, according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

Importance of GMP

GMP is a critical concept in pharmaceutical industry. Many countries have legislated GMP procedures for the manufacturing units, with an aim to ensure the quality of medicines and thereby safeguard the health of patients. If the manufacturers fail to comply with the standards, their license may be cancelled or their product may be banned, and they may be charged for negligence/ non-compliance.

A Recent Case of Non-compliance With GMP

Generic Drug Manufacturer Ranbaxy Pleads Guilty and Agrees to Pay $500 Million to Resolve False Claims Allegations, cGMP Violations and False Statements to the FDA.
(source: The United States Department of Justice)

Is GMP Training Beneficial?

Compliance with GMP requires a well-trained and qualified work force. Training is a compliance requirement, but it also leads to multiple operational benefits in the form of fewer errors, reduced waste and more efficient performance. Every employee involved in manufacturing, packaging, holding, storing, transferring, etc. of any drug must be trained on GMPs for long-lasting benefits.

GMP training is beneficial to organizations in multiple ways. It is used to:

  • Raise awareness among the key (responsible) people about the benefits of following GMPs
  • Educate your employees on the best practices to comply with GMP and how to avoid the ‘compliance pain’ in your organization

Why Elearning for Training?

E-Learning has proven to be a promising solution for compliance trainings.

One-time solution: You pay for an eLearning course once and you can use it to train your employees not once, but as many times as you wish. It can be taken by multiple employees with no complications.

Flexibility of place and time: eLearning gives employees the flexibility to take the course anywhere and anytime.

Training for specific job functions: Separate eLearning courses can be designed to meet the requirements of specific job functions. This way you can avoid the ‘All-in-one’ training sessions attended by all employees; you can also reduce the unnecessary cost and time of long training sessions.

Works as a refresher training:The eLearning courses can be used as refresher training, to re-qualify the employees for their job role, on regular intervals with minimal/no cost.

Case studies: eLearning course can include case studies, to explain what happened due to non-compliance and what should be done to avoid it. Employees can be assessed based on their work situations and detailed feedbacks can be given, to enhance learning.

Training process and equipment enhancements: There are regular process and equipment enhancements in organizations, which reflect the manufacturing practices. E-learning can be an easy solution, as the course content can be edited at negligible cost.

A screenshot of GMP slide from one of our compliance courses:

 ScreenShot from a GMP Compliance Course

Initially when an organization wants to train their employees on GMPs, they can go for Instructor Led Training (ILT), and later they can use blended (ILT & eLearning) or eLearning for continuous and improved benefits.

View Presentation on Effective Compliance Training Program - Ways to Reduce Compliance Risks

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