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Are you still struggling to implement a Contamination Control Strategy as per new EU Annex-1?

Keeping sterile drug products from being contaminated has long been a challenge for the pharmaceutical industry. Recalls and regulatory actions on drug products are frequently caused by product contamination and the failure to develop and maintain a state of control for microbiological as well as particulate contamination.

The new Annex 1 offers a path for improved contamination control. It outlines a means to accomplish this with a comprehensive, all-inclusive Contamination Control Strategy (CCS), that “… should be implemented across the facility in order to define all critical control points and assess the effectiveness of all the controls (design, procedural, technical and organizational) and monitoring measures employed to manage risks associated with contamination.” It describes how various elements need to be considered in a holistic way while building such Contamination Control Strategy. Even if companies are currently assessing, controlling, and monitoring the contamination sources individually, the revised Annex-1 proposes they look at their collective effectiveness together. The benefits of this holistic approach are:

  • A comprehensive program that ensures proportional attention to all critical control points,

  • A holistic program that builds awareness of various contamination sources, how they are interconnected and their combined impact on product and patient risks.

  • A reduction of ineffective control efforts and individual subjectivities, allowing for better allocation of resources, optimal benefit, and continuous improvement.

In order to address the contamination concerns, the new guideline expects a better use of knowledge acquired about the risks associated with the products and processes as well as the organization's expertise of contamination control. As a result, this entire program revolves around the employees. This is also clear from this document's extensive "Personnel" section.

So, it’s the time to ponder whether your team at shop floor is geared up to embrace this change?

The contamination control modules offered by INOVR helps users comprehend the numerous causes of microbiological and particulate contamination as well as strategies for keeping them under control. The benefit of virtual reality training is that participants can visualize microscopic particles that are invisible to the naked eye. This aids in improving knowledge retention while also fostering a deeper comprehension of the subject. Additionally, users can complete the trainings at any moment during their free time and receive certifications. Thanks to the convenience of auto-guided courses (which do not require a physical trainer). This helps individuals to participate in such trainings more frequently and become proficient with practice options.

Please reach out to our team if you want to learn more on this.

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