Tag Archives: quality

  • 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 …

  • Lean Biomanufacturing: Keeping Your Eye on the Quality Goal

    … going to hurt our companies and the industry as well. Lean manufacturing in medical products, which should include but need not necessarily be limited to pharmaceuticals, vaccines, biotechnology products and medical devices is all about producing the highest quality products for consumers. As already noted, this is frequently missed out when one talks about Lean because out culture is often heavily geared towards the efficiency component. This is naturally understandable in a highly competitive …

  • Leachables and Extractables in Biopharmaceutical Processing

    … might be much greater. With the potential for both Leachables and Extractables to have a marked effect on the quality and safety of protein therapeutics, the challenge is therefore on to find better testing methods to provide an adequate level of sensitivity and specificity that will assure both quality and safety concerns are met. Similarly, provider companies are looking at newer materials that may not have the same potential contaminating profile which might reduce or minimize the problem. …

  • 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 …

  • 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 than separate them as “end-game” outcomes. Compliance requires systematic control of elements connected to and driving manufacturing …

  • 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 …

  • Lean Philosophy and the Life Science Industry

    It’s generally accepted that standard Lean approaches have not been well implemented in the pharmaceutical industry.  We feel that this is largely  due to a lack of appreciation of the complexities of manufacturing according to cGMP which is a necessity to be in regulatory and quality compliance. Although many of the basic principles of a Lean philosophy can be applied to the highly regulated Life Science Industry, implementation is often more complex due to the very stringent requirements …

  • Risk Management as part of your Lean Compliance Strategy to enable you to meet your Compliance Obligations.

    In a regulated industry like the Life Sciences Industry which covers Pharmaceutical, Biologics, Biotechnology Drugs, Medical Devices, Medical Device/Drug Combination Products, Diagnostics and Tissue Therapies, adherence to strict regulatory& quality compliance  principles is a given. However, over killing what you are doing can be very costly and may be forcing cuts in other vital areas of the commercial operation. That’s why using Risk Assessment Techniques to develop a Lean Compliance …

  • Pharmaceutical Consultants-The Key to a Rapidly Changing Industry

    … to adopt pertinent changes so as to remain competitive when the trends are in full swing, thereby applying a type of preventive medicine. Make no mistake, quality pharmaceutical consultants can be an invaluable asset. From developing a relationship built on mutual trust and respect, to their vast industry specific knowledge and analytical skills, qualified pharmaceutical consultants provide the tools and support that enables their clients to successfully manage costs, improve business …

  • Lean Manufacturing and PAT – The Next Level For Pharma

    In 2003 the FDA announced the Process Analytical Technology (PAT) initiative to “encourage the voluntary development and implementation of innovative pharmaceutical manufacturing and quality assurance.” This initiative was designed to improve process efficiency of both manufacturing and regulatory phases, and is comprised of four components: data analysis, process analytical tools, process monitoring, and continuous feedback. The quality-by-design aspect of PAT will reduce cycle time thus …

  • Lean Manufacturing Solves Drug Recalls and Bad Press

    … 75% of drug recalls can be attributed to manufacturing defects, the compartmentalized nature of the departments within the process, and burdensome regulatory compliance concerns among others. Further complicating the situation is the growing use of contract manufacturing organization’s (CMOs) which require companies to manage increasingly complex external relationships without compromising quality. According to Nigel Smart, Managing Partner of Smart Consulting Group, “With so much …