Tag Archives: control

  • 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 …

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

    … this is the Risk Assessment of environmental  monitoring plans to determine the appropriate level of sampling required to assure environmental control while staying within the requirements to operate an effective program. Studies indicate that savings for modern biotechnology production facilities can be in the millions of dollars per annum due to the reduction in testing materials, testing and labor required to collect and test the samples. Determining sample plans using a simple Risk …

  • 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 …

  • Lean Manufacturing and PAT – The Next Level For Pharma

    … reducing the wastes of waiting and excess inventory already identified by lean manufacturing. The early efforts with PAT were focused chiefly on the single aspect of developing and applying analytical tools for timely in-process measurements. However, to fully realize PAT’s goal of complete understanding and control of the manufacturing process, a bigger toolkit must be used. The tools recommended by the FDA are multivariate tools to handle design, information gathering and analysis, process …

  • Pharmaceutical Consulting Firms: Hero or Hype?

    Pharmaceutical consultancy is emerging as a way for manufacturers to manage the increasing pressures of rising costs, heavier regulatory compliance, and stiffer competition. Although a relatively new area of expertise, pharmaceutical consultants are proving to be a valuable asset to both pharmaceutical manufacturers facing rising costs of R&D, production, and distribution, as well specialized healthcare services trying to control their own rising costs. Everyone is finding themselves in …

  • What You Need to Know About Vendor Audits

    A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.  The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.  This need for a closer monitoring of a vendor’s qualities and practices stems from an ever-evolving …

  • Key Factors in Third Party Testing on Combination Products

    Proper and unbiased testing is an integral part of any manufacturing process.  And this is especially vital in the pharmaceutical industry.  Because of the pharmaceutical industry’s inherent need for quality control, at the highest levels, a new form of testing was required to ensure the highest quality products available.  This form of testing is known as third party testing, where an independent third party testing operation, test the quality of the product in question, off site at …

  • 5 Important Factors to Measure in Your Lean Process Strategy

    Lean process procedures are a companywide initiative, with the goal to achieve operational excellence.  It is a kind of systematic approach that facilitates improvement on every level, while putting process efficiency and product quality control at the top of the list, and delivering faster service and cost reduction.  The implementation of Lean philosophy is no longer being used in the old manufacturing sense, but is now being implemented in new and exciting ways all across the pharmaceutical …

  • Growing Cooperation between Big Pharma and Patients

    … pharmaceutical industry are expressing a newfound willingness to cooperate together, that just hasn’t been seen in recent years.  Through this dialogue some pharmaceutical companies have already taken steps in this direction particularly in the way they are  trying to  improve patient care whilst attempting to control costs. Only time will tell whether this new found cooperation will net any real positive gains for patients,providers and pharamaceutical companies, but many in the …

  • The Lean Laboratory of the 21st Century

    … These fears stem from a concern that a Lean manufacturing approach will cut down on the quality control of a product, resulting in lower quality products, which may result in lawsuits or non FDA approval.  But as more companies in the pharmaceutical industry begin to use Lean strategy with great success, many in the field are optimistic of its effectiveness in the future. If your pharmaceutical company is looking to apply Lean strategies to your business, then contact a pharmaceutical …