Tag Archives: regulatory bodies

  • Management Responsibilities and Automation Techniques in Regulated Pharma Environments as Per a Suggested Quality System Model

    … regulations, the FDA’s Critical Path Initiative, ISO 9000 standards, and/or the requisites of foreign regulatory bodies. However, in the ‘Quality Systems Approach to Pharmaceutical cGMP Regulations’ support document, the FDA introduces a potential Quality Systems model that could offer the elements that pharmaceutical companies require to start, or keep on, growing a top-functioning Quality System capable of meeting the institution’s regulations and requisites. The quality …

  • The Pharmaceutical Industry is Under Pressure

    … while sharing some drinks is the best way to finish a long successful day and make friends.  Round tables offer you the opportunity to hear expert opinions, interesting discussions, and even join in with your own questions or suggestions. Look for networking opportunities offering you solid information on potential partners and competitors.  Look for insights from biotechs and pharma, overviews from regulatory bodies, coaching from independent professionals and worldwide innovations. Be …

  • Striving For A Change

    … variability. Automated checks are far more precise and can be easily audited by the FDA and other regulatory bodies. Data can be collected from every part of the supply chain and manufacturing process, manufacturers now understand how various process adjustments can affect directly the technical attributes of the material. The pharmaceutical industry is back. Little by little, quality and efficiency have been improved, ensuring consumers’ welfare and loyalty as well. At the beginning, …

  • Lean Operational Compliance in the New Pharmaceutical Industry Environment

    … needs, and other undesirable circumstances. With lean compliance systems, both regulatory bodies such as the FDA and the industry at large can now look at a quicker compliance process that reduces burdens to both sides. The current lower revenue and margin environment has not been kind to the pharmaceutical industry, and will probably take a couple or more years to overcome. However, these circumstances have made the reward for change more appealing and brought the opportunity to bring …

  • Lean Six Sigma and Process Excellence to the Rescue

    … the consequences.  Luckily, in recent years, they have received some support from the FDA and other regulatory bodies, which recognize the lack of efficiency and quality control and have backed up a “quality by design” model to substitute the previous one of “quality by test results”. The FDA has established the Process Analytical Technology (PAT) initiative, which aims at guiding pharmaceutical manufacturers towards consistent, predictable, and higher quality levels.  By accepting …