Probably the biggest concern for anyone implementing, deploying, and maintaining a quality management system (QMS) is the integration of risk-based thinking. While the concept of risk management is not new, previous practice was more reactionary, primarily focused on detection after the fact, root cause analysis, corrective actions, and preventing recurrence of the failure. Contemporary thinking places the emphasis on considering risks up front (prevention) and having a solid approach to address risk in planning, managing, and driving actions.
Manufacturers of sterile products must engage in critical thinking, asking “Why?” and “Why not?” questions, challenging and pushing the industry towards more effective means of quality and process control. In this way, we can ensure that we are prepared to meet the challenges of providing sterile pharmaceutical products that are not only safe and effective, but also are available and affordable for the patients who depend on them.
Cleaning manufacturing equipment to prevent cross contamination of pharmaceutical products is a fundamental aspect of GMPs. Validation of cleaning processes has been required within cGMP industries for a long time and is recognized as an important activity to establish that product cross contamination is controlled to ensure patient safety and product quality.
Successful implementation of quality by design (QbD) can lead to significant revenue growth and margins from the shortened development cycle. However, in our recent reports on the state of ICH Q8-11 guideline adoption in the industry, we confirmed that, despite the sound rationale of the new operating paradigms, industry uptake has been slow since the publication of the guidances nearly a decade ago.