By Gail Dutton, Contributing Editor
Big Pharma and small companies alike are failing when it comes to cGMP violations. The increasing number and complexity of global regulations, outsourcing, price pressures, and compressed time to market all contribute to these failures. Consequently, the number of compliance issues is expected to rise.
By Malcolm McLaughlin
Cleaning validation is a necessary and time-consuming part of manufacturing pharmaceuticals. The validation process can be expedited, and cost of validation can be lowered, if the cleaner supplier can provide support, allowing for pharmaceuticals to get to market faster and at a lower cost. This paper outlines the basics of cleaning validation, as well as discussing the kinds of support services you should seek from your supplier of critical cleaning products, in order to optimize your cleaning validation process.
By Chuck Reed, Weiler Engineering, Inc.
Maximized uptime, minimized changeover time, and efficient OEE are key factors that have influenced the acceptance of aseptic blow/fill/seal in the packaging of pharmaceutical liquids.
By Mark Mohr, CSafe Global
Healthcare product manufacturers, transportation providers, and distributors have a moral, and in most cases also a regulatory, responsibility to help ensure the product arrives to the end user intact. Protection of product efficacy demands use of the latest reliable technologies available. People's lives truly depend on it.
By Ariette van Strien, Senior Vice President, Commercial Operations, Marken
The dramatic shift in our industry from small molecule drugs to high-value biopharmaceuticals is increasing the need to focus on logistics and supply chain management.
By James Drinkwater
Biocontamination found in critical zones within processing environments can affect the whole process and sterility of the final products, potentially putting patients at risk. This can lead to significant financial costs and impact operational resources.
By G. McDonnell
Various sterilization methods (including gamma irradiation and ethylene oxide) have been widely used for terminal medical device sterilization. No single method offers the perfect sterilization solution for every application.