Tag Archives: compliance

  • 483 Audit Forms

    … need to take place. If you receive a 483 Citation and are not sure what to do next, make sure to reach out to experts in FDA consulting services…a group you can trust. The professional team at Smart Consulting Group  has many decades of experience in remediating FDA compliance issues. Give our team a call today. We look forward to helping your company reach a positive solution!   * The above facts noted, regarding 483 citations, were referenced from the FDA’s website. For more …

  • 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 …

  • 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 …

  • 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 …

  • 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 …

  • Pharmaceutical Consultants-The Key to a Rapidly Changing Industry

    … from all sides, particularly through the impact of new technologies across the whole discovery and development process and from changes in the way that health care is funded and delivered.” The changes Peakman spoke of have progressed even further, and there are other, more radical changes than those he had in mind in 2000. Growing FDA intrusion and compliance burdens, a dwindling number of blockbuster drugs and looming patent expirations, slowing growth in the market and shrinking profit …

  • 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 …

  • Pharmaceutical Consulting and BMI’s 4th Quarter Update

    … Additionally, developments in the third quarter of 2010 will almost certainly result in even heavier compliance and regulatory burdens for drug manufacturers, especially with respect to the OTC segment. The events included the recall of 21 lots of medications – among them certain Tylenol products, as well as Benadryl and Motrin – by Johnson & Johnson. In addition, the FDA recently initiated a new program that will make the safety evaluations for recently approved drugs and …