Compliance Management Featured Articles

  1. The Critical Role Of Residue Removal In Cleanroom Biosafety Cabinets 3/28/2024

    Learn about the significance of residue removal, how it is effectively performed in cleanrooms to ensure the compliance of biosafety cabinets, and the impact of proper residue removal.

  2. Managing GxP Environmental Systems To Ensure Data Integrity 3/9/2017

    In the life science industries — pharma research, manufacturing, medical devices and biotech — guidance and regulatory enforcement strategies are being re-evaluated with a focus on data integrity.

  3. Pharma's Quest For Consistent Quality 5/19/2015

    The preliminary findings from the International Society of Pharmaceutical Engineering’s (ISPE’s) Quality Metrics Pilot Program were revealed at the association’s recent Quality Metrics Summit. How will this data help the pharma industry create a universally accepted set of manufacturing quality standards and what challenges did the pilot uncover?

  4. Shifting Pharma's Mindset: Viewing Quality As Value Creator, Not Cost 5/14/2015

    The pharma industry is quickly, and fortunately, realizing that the value that quality creates can far outweigh the cost savings associated with not investing in it.

  5. Solving The OOS Problem With Continuous Manufacturing

    With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec.

  6. Incorporating Lean Principles Into Pharmaceutical QC Laboratory Design

    This article presents a case study based on an international workshop hosted by Novartis Vaccines to prepare guidelines for incorporating lean principles into pharmaceutical quality control laboratory design. By Mike Dockery, Federico Gabardi, Javier Garay, Jim Gazvoda, Luke Kimmel, Pietro Orombelli, Christophe Peytremann, Tom Reynolds, Tanya Scharton-Kersten, Graham Shoel, and Jeanne Sirovatka

  7. Calibration Risk Assessment: Where Do You Start?

    I have a question about Risk Assessment analyses for product impact from sensing instruments that have gone out of calibration, specifically in GxP-compliant applications.

    Do you have any recommendations on books, training courses, or other resources for managing this?