I can't tell you how much I've looked forward to you opening this newsletter! At first glance, you'll notice we have a brand new look. Our team has worked diligently for months to narrow down topics, design potential formats, and screen new writers in order to ring in the new year with style.
I'd like to thank many of you for taking time to talk with myself and the Pharmaceutical Online team during the past year. Your input drives our decisions, and it played a big part in the topics and content we've chosen. Each issue will now feature valuable insights and solutions that fall under seven categories: liquid-dose manufacturing, solid-dose manufacturing, packaging, QA/QC, inspection, logistics, and critical environments. We hope you like our new format and find information that you can use in your day-to-day work. Please email me and let me know what you think! I also invite you to share any trends or challenges you'd like to see covered in future issues.
By Anil Doshi, R.Ph., Ph.D., President, Infinity Pharmaceutical Consulting
Any pharmaceutical company that initiates and implements QbD (ICH Q8, Q9, and Q10) effectively and efficiently, will fully leverage a competitive advantage in 21st century. The prudent implementation of this strategy, based on good science and an accurate grasp of the available regulatory knowledge, will create transformational value by providing high product quality assurance for patients, more efficient regulatory oversight, and cost savings for the company.
There are a few questions to ask yourself when determining which liquid filling machine is right for your project. As each machine is unique in its filling techniques and performance abilities, certain questions that are asked will help to narrow down the choices and select a machine that will best suit your application.
While a delayed flight can be a major inconvenience for passengers, for extremely valuable pharmaceutical shipments that must be kept at a narrow band of controlled temperature, delays can be catastrophic.
Due to the movement toward 100% inspection of raw materials, increased production volumes, as well as lean manufacturing, pharma manufacturers are seeking ways to improve product quality and lower costs in analytical testing of raw materials.
Given the high cost of conducting global clinical trials, and the even higher cost of failure, regulatory agencies and pharmaceutical companies alike now demand that every party involved in the pharmaceutical supply chain — transportation and logistics providers included — conform to GxP guidelines.
When facing a microbial contamination challenge, whether from multidrug-resistant organisms in a hospital or in bio-pharmaceutical production facilities, not all hydrogen peroxide-based decontamination systems are the same. Differences in the technology lead to differences in microbial efficacy and clinical impact.
Aseptic manufacturing processes have evolved over a long period of time and are capable of producing high-quality parenteral products. The current growth in sterile biopharmaceutical products brings challenges as well as opportunities to the industry in terms of developing in-process monitoring and control strategies that keep processes in a state of control and minimize the risk of product defects.