Tag Archives: problem

  • 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 …

  • Kaizen Events

    … activity and something that should be heavily documented. These events can be tracked with special documents known as Kaizen storyboards. With a Kaizen storyboard one must first identify the problem or the current situation. The next part of the storyboard involves explaining one ideal situation. Following that step, one must pinpoint the target measures, such as target yield metrics or unit operation cycle time targets. The final sections of the storyboard include understanding the Kaizen plan …

  • 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

    … 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. …

  • Issues Connected with Device Combination Product Convenience Kits

    … they’re included in the paper convenience trays. If manufacturers are to use these types of device combinations, then an alternative material of construction may be required to avoid this issue or possibly a modified sterilization cycle will be required which provides assurance of the removal of the sterilant. As a first step testing is needed to quantify the extent of the problem. Only when the size of this issue is understood can a resolution be developed. These are complex issues which …

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

    … that must be resolved before a World Class Manufacturing situation is realized. 5S philosophy addresses this problem head on as follows: Sort: Only equipment and other items required to meet the manufacturing function are retained in the designated space. All other equipment is removed and either disposed of or returned from wherever it originated. Straighten :Once the above is complete, the essential equipment and instruments are appropriately labeled and put in a logical designated place …

  • Issues for Device Combination Products

    … they’re included in the paper convenience trays. If manufacturers are to use these types of devices, then an alternative material of construction may be required to avoid the issues, or alternatively a modified sterilization cycle will be required which assures the removal of the sterilant. As a first step however, testing is needed to quantify the extent of the problem before the right strategy can be developed. …

  • Lean Manufacturing Solves Drug Recalls and Bad Press

    … talk about outsourcing off-shore, American jobs are being lost at an alarming rate in an area where there’s been traditional strength. Strategically, this is a problem for the US Pharmaceutical industry. Perhaps now’s the time for us to re-assert this strength? However, we’ll only be able to do that if we apply the appropriate techniques and methods in a logical and consistent fashion.” Fortunately, manufacturing is the one aspect of drug production most amenable to change …

  • Pharmaceutical Consulting and BMI’s 4th Quarter Update

    … examine each situation and problem from every perspective then, through analysis and testing, formulate multiple possible solutions. Management and consultants then work together to determine the best solution. Some of the critical areas that pharmaceutical consultants can provide assistance with are: Quality and compliance Good manufacturing practices (GMP) FDA regulatory concerns and adherence Laboratory services Lean manufacturing Training and coaching Smart Consulting Group is …

  • Pharmaceutical Consultants Broaden the Scope

    … pharmaceutical consultants provide with respect to attitudes and the way people approach problems and solutions. Why is this important? Because the way we view a problem determines in large part whether or not we find a solution for said problem, and how effective it will be. On September 11, 2001, the unthinkable happened. Foreign terrorists attacked Americans on American soil, killing and maiming thousands. The terrorists, some of whom were living in this country and had been educated here, …

  • Hiring a Pharmaceutical Consultant: 7 Steps to Success

    … situation. Instead, what is needed is for your consultants to look at the problem(s) from every possible angle and perspective, analyze and test ideas, and then develop multiple potential solutions. Then, together, you can decide which solution will be the best one – not only now, but also in the long run. Flexibility doesn’t end there, however. For example, the project associates with Smart Consulting can even work as substitute staff and as temporary team members if need be. 4. …

  • Avoiding the Pitfalls of Pharmaceutical Consulting

    … Consulting will first come in and conduct an initial assessment, viewing the situation from all sides and angles, thus gaining a comprehensive view and understanding of the problem(s). From here—because the consultants aren’t locked in to one way of seeing and doing things—they can find and develop multiple possible solutions, each of which are then tested and adjusted accordingly. This allows them to determine exactly which solution is best suited for a particular problem. Smart’s …