Managing QbD From A CMO Perspective
The concepts and methods of Quality by Design (QbD), which the automobile, airline, and electronics industries have utilized to enhance the quality and reliability of their finished products, are gaining traction in pharmaceutical manufacturing. QbD enables pharmaceutical and biotechnology companies to identify, analyze, and control the sources of variation in manufacturing processes that can lessen the quality of drugs and other therapeutic products.
WHITE PAPERS & CASE STUDIES
Detection of Microbial Contamination in Sterile Containers using Headspace Analysis
Sterility testing in the pharmaceutical industry has long been based on growth media culture methods. The general approach is to incubate for 14 days and then determine potential contamination with a visual inspection of the media sample
Container Closure Integrity of Sterile Vials During Deep Cold Storage
Certain sterile pharmaceutical products require deep cold storage, either at dry ice (-80°C) or even cryogenic (−196 °C) temperatures.
Nitrogen Purge Optimization and Validation of Sterile Liquid Filling Lines
Sterile liquid filling lines are increasingly being implemented with nitrogen purge capability during filling.
Container Closure Integrity Testing in Lieu of Sterility Testing in Stability Protocols
When the Food and Drug Administration published “Guidance for Industry: Container and Closure System Integrity in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products”
Improve Your Facility Monitoring System To Comply With Regulatory Requirements
A facility monitoring system (FMS) is a process monitoring tool that collects data from sensors such as optical particle counters, differential pressure sensors, and temperature probes in realtime. Acronyms are independent monitoring system (IMS) or environmental monitoring system (EMS). Software presents that data as information; real-time alarms notify facility operators of alert limits to enable an immediate response to an unwanted event or excursion. Reports and trend graphs can be produced.
How To Increase Regulatory Flexibility And Tablet Production Efficiency
The goal of every pharmaceutical developer is to create quality products which generate consumer satisfaction, require low cost, and have low risk. Quality starts from the moment of conception of an idea and continues throughout production.