Smart Consulting Group Blogspot
Smart Consulting Group Blogspot
- October 4, 2011
- Leachables and Extractables in Biopharmaceutical Processing
- With the burgeoning interest in the use of disposables for the production of modern biopharmaceutical products, the level of scrutiny surrounding the topic of Leachables and Extractables has moved into a higher gear. It seems that there is an endless amount of attention being paid to this topic because of the potential impact on patients [...]
- September 16, 2011
- Venturing into the Bold World of Combination Products
- - By Michael Hemenway For a traditional medical device company contemplating a decision to develop a combination drug-device product, the question of whether or not to pursue this type of product should be weighed carefully. While there might be a benefit to the patient from such a product, the benefit should be compelling and perhaps [...]
- September 15, 2011
- Don’t keep failing, implement a LEAN Laboratory approach!
- So your QC laboratory is failing to keep up with the manufacturing group. Your number of samples is increasing and there are new products coming down the road which promises yet more samples. Your laboratory analysts are working harder and longer hours just to maintain parity. Overtime costs are exploding and errors are increasing which [...]
- August 20, 2011
- Disposables and Single –Use Systems: A Way to Drive Biomanufacturing from a Lean Perspective
- Over the last ten years we’ve seen a massive change in the way we look to manufacture biopharmaceutical products. Increasingly the methods and technology that were in vogue through the late 1980’s and 90’s are being superseded by new disposable options.
- August 8, 2011
- NDC codes: National Drug Codes and How They are Assigned
- The NDC code is a 10 digit code that is applied to uniquely identify products having a drug registry component. The number is a 3 segment number in terms of its construction and the various components correspond to sections responsible for the label, the product and the packaging. The first section identifies the labeler code, [...]
- August 8, 2011
- Issues Connected with Device Combination Product Convenience Kits
- The development of medical device combination product convenience packages continues to throw up interesting technical/regulatory challenges. Inclusion of pre-sterilized syringes and other applicators as part of these products poses problems for manufacturers and distributors due to the possibility of post sterilization contamination and/or plastic leachables/extractables. Most device convenience kits are ETO sterilized and this can [...]
- July 15, 2011
- Do Start up Life Science Companies need Quality Management Systems?
- So you may be a start-up or virtual life sciences company, but you still have a requirement to have a Quality System to develop your pharmaceutical/life sciences products. That’s true if you are a company that is regulated by the FDA and major international regulatory agencies that conform to ICH guidelines. Although you’re not likely [...]
- June 14, 2011
- Shortened Lead Times as a Key Component of Lean Biomanufacturing
- A significant driver in the improvement in bioprocess plants profitability relates to the reduction in non-value added lead times.
- June 9, 2011
- Lean Product Change–Over in an FDA Regulated Environment
- Some would argue that there is a conflict between the idea of lean practices and a highly regulated quality compliant environment. However, upon closer analysis this is not necessarily the case. Both Lean and Compliance have very definite requirements to operate properly and it’s this discipline of implementation and execution that can bind both rather [...]
- May 11, 2011
- Reaching into Research and Development of a Supply Chain Strategy
- Critical materials and suppliers are selected early in development. By the time Technology Transfer occurs for commercialization, it is often too late to make changes to these critical components without having to do additional testing or even repeating clinical trials. Regulatory authorities have made securing the supply chain a priority and have promised serious repercussions [...]
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