Risk Management Featured Articles
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Drug Shortages Highlight Quality Problems
6/5/2015
On the same day the Wall Street Journal published an article highlighting the issue of drug shortages in the US, CDER Director, Dr Janet Woodcock, delivered a keynote at the ISPE Quality Manufacturing Conference. Dr. Woodcock discussed initiatives by the FDA to overcome issues with manufacturing quality, a leading reason for drug shortages in the US.
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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.
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The Impact of Well-Designed Weighing Processes On Product Quality
4/22/2015
Companies involved in the production of pharmaceutical products are well aware of the importance of consistency and accuracy in manufacturing processes. Batches that fail quality inspections waste time, labor, effort, and resources. This further leads to a loss in profits and market reputation, as well as compromises human health and safety.
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Best Practices In Biomanufacturing Supplier Relations: Reducing Raw Materials Risks
9/17/2014
Quality management is a matter of increasing importance to the biopharmaceutical manufacturing industry. In recent years, facilities have been gravitating toward quality-related analytical programs, and our data tells us they are also getting tougher on suppliers.
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FAQ's: Regulated Films For Containment Solutions
9/11/2014
At ILC Dover, we are always "creating what’s next" by listening carefully to our customers. In response to customer input and emerging regulations, we've developed a robust new film to support our DoverPac® Containment Solutions line. This revolutionary product, ArmorFlex® 110, delivers permanent static dissipative properties while meeting FDA and 2002/72/EC requirements for food contact.
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Analytical QbD at Teva: Knowledge Is Power Only When You Share It
7/3/2014
Rosario LoBrutto, is currently Senior Director, Head of Development Parenterals at Teva. Throughout his career he has designed, coordinated, and implemented QbD programs and provided risk management trainings to product development units (quality, analytical, formulation, process chemists), and quality control, regulatory, and operations units. He understands the value of risk assessment and strategy for proactive failure reduction as opposed to reactive trouble shooting. In his interpretation of the ICH Harmonised Tripartite Guideline for Pharmaceutical Development Q9, a guidance document for QbD, LoBrutto breaks the QbD process down into three phases of risk facilitation as it relates to analytics.
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Human Error Is The Leading Cause Of GMP Deviations – Or Is It?
5/1/2014
Think of your company’s deviations. Concentrate on their most common root cause – the one you see most often and have the hardest time fixing. My high-tech-mind-reading-helmet tells me your answer is human error, correct? Magicians aren’t supposed to reveal their tricks, but this one really isn’t much of a trick. Every company wrestles with human error. We know humans have error rates – we’re not perfect. But how many is too many?
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Biopharma Quality Management Best Practices: An Approach To Quality Initiatives
4/1/2014
Quality management is an increasingly important focus for biopharmaceutical manufacturers looking to avoid production problems and failures. And it’s increasingly becoming a multifaceted, industrywide concern as regulators take a closer look. With this in mind, it’s useful to see how the industry is approaching quality management in terms of the initiatives being pursued.
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Out With The Old, In With The New: GSK’s Smart Workplace
2/24/2014
By eliminating the confines of the traditional workspace, companies can encourage better employee interaction and collaboration. Will this be the key for an industry counting on innovation to lead it into the future?
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QbD: Lessons Learned From An FDA Filing
2/24/2014
Implementing quality by design offers not only a proactive approach to product development, but also the opportunity to streamline your filing process.