By Joanna Gallant
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?
By Giuseppe Bonfiglioli, Bonfiglioli Engineering
Production of tablets and capsules is carried out in cleanrooms and under stringent procedures as per GMP requirements. However, the process also relies on machines and machine operators, therefore, misappropriate handling can result in a faulty blister pack containing micro leaks in the packaging, allowing air and moisture to enter the blister and damage the product.
By Karen Bell, Product Marketing Manager, Revitas
Generic pharmaceutical manufacturers are facing a business dichotomy: The overall market for generic drugs is growing but at a slower pace as the number of branded drugs entering the market is shrinking, diminishing opportunities to capitalize on expiring patents. Consequently manufacturers face numerous challenges that can significantly impact operational efficiencies and revenue growth.
By Tara S. Hundley, Anton Paar USA
For those of you who work with any analytical lab or process instruments, you know that staying in compliance with global regulations has become burdensome in the past decade. Everyone is fixated on streamlining production processes and reducing the bottom line. This means getting new instruments into the work flow as soon as possible; but to do so you need to know everything there is to know about equipment and instrument qualification. In the overall pharmaceutical manufacturing process, you may be just one cog on the gear of productivity, but without some help, you could go from cog to clog very quickly.
The 4th Traceability and The Drug Quality and Security Act Summit, May 15 and 16, 2014, at the Sonesta Hotel in Philadelphia, PA, brings together a cross section of supply chain, serialization, traceability, security, and brand protection experts to discuss the impact of the DQSA, best practices to optimize and protect your supply chain, and how to provide business value through serialization and pedigree beyond regulatory compliance. Register today with discount code "C452LCS". Learn more.