Tag Archives: result

  • 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 …

  • Bottlenecking Theory

    … biomanufacturing.  Bottlenecking can occur as a result of resource limitation as well as when one does not have the correct tools/equipment readily available. Why would a store clerk sell a shirt that is no longer in stock? They wouldn’t!  This is why it’s important to know what resources or quantity you have available at all times. In the case that bottlenecking does occur, one must spot the issue and easily remediate it, which is probably something that should have been done early on. …

  • Fishbone Analysis

    … otherwise known as the ‘5 Whys’ Analysis. Create a list of “Why 1, Why 2, Why 3, etc.” Then next to each item, identify the problem and then describe why that particular result occurred. Asking sequential questions, while filling out additional bones of the fish structure for each sub-reason, provide a fantastic “checks and balances” system for researchers. For additional information, including case studies on fishbone analysis, refer to Lean Biomanufacturing by Dr. Nigel J. Smart. …

  • 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 …

  • 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 …

  • Metrics and their Importance in Lean Biomanufacturing

    … consistently made product with very tight technical and quality specifications. In developing Lean approaches to these manufacturing processes, metrics provides the information which is the life blood from which biochemical engineers can balance the needs of meeting quality specifications with running the process plant as efficiently as possible. A key metric in any biological process is the changeover time, since this is where production time is lost. As a result this is a valuable data set …

  • Eliminating Pharmaceutical Manufacturing Chaos through Implementation of an Effective 5S Program

    … often the result and inefficiency together with an increase in work related mistakes is the eventual outcome. Whatever the outcome you choose to define, the impact on the manufacturability is to affect at least one of the following: decreased finished goods productivity, increased cycle times, raised error frequency, increased waste production, increased accumulation of WIP (work in progress) and a disruption in workplace organization. All of the above contribute to an unsatisfactory situation …

  • Lean Enterprising; A term coming of age in the Implementation of Lean in the Life Science Industry

    … As a result more integrated approaches now involve the inclusion if IT/IS systems and networks, production control systems, supply chain and supplier networks, compliance & regulatory systems and the use of the organization’s human resources.. Proper integration of these factors, where there is a focus on proper human resource development & their application to waste minimization, and an emphasis on customer driven production, is at the heart of the new 21st Century paradigm for the …

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

    … of different sizes or even different connectors might solve this issue. 2. Failure systems that did not fail closed results in loss of product or contamination of product. 3. Mix ups in products due to transfer of product dust as a result of improper air flows between adjacent pressurized rooms. 4. Double mechanical agitator seals installed incorrectly in bioreactors causing lost batches due to contamination problems. 5. Steam traps on sterilized systems connected incorrectly or not opening at …

  • The Use of Process Mapping, Value Stream Mapping and Score Cards in developing a Lean Culture in Life Sciences Companies.

    … (in the EU). This plays a significant role in changing how certain elements are used and makes the opportunity for successful implementation more of a challenge. That said simple techniques such as Process Mapping, Value Stream Mapping & the use of Score Cards are often employed sparingly to the detriment of the operating company. In our experience, simply by initiating the use of these tools and techniques, massive gains can be made in the streamlining of processes which result in huge …

  • New Data on the Inspection of Human Cell & Tissue Products by the FDA

    A recent report charting inspectional information by the FDA for human cell/tissue therapeutic products shows a marked increase in inspection activity. The period covered is 2003-2010 and reports an increase in the number of inspections by about 250%, with an average duration of each inspection of 40-45 hours. During that period, voluntary compliance actions taken by companies as a result of inspections has increased 255% and official action taken has increased 240%. This is against a background …

  • Lean Approaches in Bioprocessing to Help Minimize Variability in Production Yields

    … upstream and downstream ends of a process and this is frequently due to poor operational control. As a result, throughput falls due to the failures and extra “belt and braces” measures are often applied to “make sure” that the failures don’t re-occur. This has the effect of increasing the cycle time and reducing productivity. A better strategy is to take a holistic approach and identify the roots causes and then make appropriate changes to prevent re-occurrence. Simple in concept but …