Tag Archives: products

  • Consolidation Activity in the Generic Sector

    … developed to assume that products will remain available to consumers at the right price. As producers drop out, monopolies are developed and the Federal Trade Commission is obliged to step in to protect competition and consumer choice.  This involves its own level of management which can also put stress on the company to deliver products to the consumer. So beneath the economic/business surface news of an acquisition/there’s the underlying practical considerations which may be overlooked …

  • Flow Charting

    … developing in a very systematic manner, involving products and processes that were initially defined by R&D-based bench scientists. The cost constraints involved when developing pharmaceutical and biopharmaceutical products are significant, which is why final methods, ideals for development and production are not established until there is some sort of understanding, or rather proof, that the material in question will be an effective medical product. Here is a list of the basic operating …

  • Lean Biomanufacturing: Keeping Your Eye on the Quality Goal

    By Nigel J Smart PhD, Smart Consulting Group To some, Lean Manufacturing is a meaningless concept when one is considering medical therapies or medical products. Often there is confusion in common English language, where the emphasis is on the Lean & Mean interpretation associated with just being efficient. As we all know this is a big misconception associated with our terminology and unless we pay attention then there is a real danger that we will miss the boat and create something that’s …

  • 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 receiving biopharmaceutical based therapies. As a result there is a frantic level of regulatory activity as scientists attempt to predict and quantify whether …

  • 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 is leading to more and more laboratory investigations. The pressure is mounting and there seems to be know light at the end of the tunnel. What do you do? …

  • 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, is assigned by the FDA and it identifies any manufacturer (including re-packagers or re-labelers) or distributer (under their own name) of the drug or drug containing …

  • 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 leave ETO residuals on the applicators and syringes if …

  • 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 to be inspected as an early stage company, regulators still expect that developers of human products must be stage appropriate managed in terms of compliance …

  • Poka-Yoke as a Mechanism to Assure Reliable Production of Pharmaceuticals and Other Life Science Products.

    Reliable performance is a must in any industry but no more so than connected with the production of Life Science products such as pharmaceuticals and medical devices. Poka-Yoke, the Japanese term used in Lean operations refers to the process of mistake proofing or providing a fail safe mechanism that will assure reliable operation. Eliminating defects or preventing operational mistakes can have a major effect on process capability, product specifications and operational efficiency, just to …

  • Lean Philosophy and the Life Science Industry

    … for thorough and comprehensive documentation and independent quality verification. What is required in applying Lean to the Life Sciences Industry is a clear understanding of where regulations require commitments and specific actions even though a value stream analysis may show those actions to cause a bottleneck. Making pharmaceuticals and other Life Science products is a complex marriage of biology, chemistry, engineering and regulatory compliance. Get one of these out of balance and the …