Tag Archives: product

  • Consolidation Activity in the Generic Sector

    Consolidation within the generic industry continues to occur at breakneck speed through merger and acquisition activity. Multiple major players are engaged in not one but several mergers simultaneously, a fact that’s perhaps confusing to some people on their respective supply chains. Integration activities often spawn their own issues as organizations with quite different cultures are fused together to blend product portfolios. These do not often fit easily and new strategies need to be …

  • SCG’s thoughts on the last 10%

    For the Pharmaceutical industry, it is difficult for consumers to tell the difference between an excellent, acceptable or poor quality product.  For this reason, safety, quality and reliability problems can go undetected  until the FDA detects them during an inspection or after investigation for a product recall.  By then, the problems can be out of control and can result in a Warning Letter or Consent Decree. The below excerpt can be found here: “ // // Seth’s Blog: The …

  • 483 Audit Forms

    … should not go unnoticed. A 483 audit is issued after the conclusion of an FDA inspection. This form states that certain conditions were cited as “in violation” of FDA standards/regulations. The FDA investigator feels that the practices or conditions surrounding the product at hand is in question and therefore a change needs to be set forth, in order for operation to continue. A company must understand the problem at stake as well as the violations that are in play as a way to avoid an …

  • 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

    … global market where cost, time to market and short cycle times play such a critical role in the success of a product. However, with that being said, the focus on product quality has at least as much an impact on success because this is so tightly bound with product safety and the eventual successful deployment of the product as a medicinal agent. The social responsibility associated with making a safe medical product is extremely important as the consequences of a defect are connected to the …

  • Leachables and Extractables in Biopharmaceutical Processing

    … there’s any regulatory impact, particularly as it relates to safety. Although issues connected with Leachables and Extractables has been discussed for over 25 years, the recent trend towards the use of new disposable methods of production which includes; wave bags, disposable plastic bioreactor inserts and their myriad of associated tubing and samplers, means that the probability of some elastomer eluting from the components or alternatively some breakdown product washing off the material …

  • 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 more importantly from a business perspective, the profit uplift from having a drug associated with the product should be large enough to more than offset …

  • 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?

    … expectations for the products they are developing and commercializing. So you just can’t leave it for later because you’re not going to be inspected. The regulatory agencies expect that you comply with the law even though they’re not necessarily checking up on you. Modern regulatory agencies require companies to have Management Controls and a Quality Plan in place even when their product development is at an early stage. As a result you can’t just leave it to your vendors and work off …