Five Areas To Focus Your QRM Strategy For Sterile Drug Products

While we can't entirely eliminate deviations when it comes to driving a car, it is imperative within a drug manufacturing process to actively mitigate risks. It is a responsibility we owe to patients relying on life-changing medicines. A little more groundwork, investment, and guidance upfront can streamline the journey toward producing efficacious, safe, high-quality drug products that meet regulatory requirements and reach the market promptly, saving both time and money in the long run.

This e-book is based on a recent survey highlighting the challenges encountered by drug manufacturing process developers. Explore five areas that can form part of a Quality Risk Management (QRM) strategy to ensure the compliant manufacturing of sterile drug products: PUPSIT in a contamination control strategy, reducing human error and the evolution of training, assuring single-use system integrity, when to perform filter validation, and data integrity compliance and filter integrity test instruments.