The new validation guidelines for pharmaceutical firms and their benefits


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The Food and Drug Administration have set up new guidelines that are more fitting for the 21st century than those implemented back in 1987. These stipulations are for the Current Goods Manufacturing Processes' process validation. This presentation explains the guidelines.

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The new validation guidelines for pharmaceutical firms and their benefits

  1. 1.  The Food and Drug Administration have set up new guidelines that are more fitting for the 21st century Better then the ones set in 1987 Stipulations are for the Current Goods Manufacturing Processes process validation
  2. 2.  Compliance specialist Michael R. Goodman with Compliance Insight says there are new key points to these current guidelines  Development concepts for modern pharmaceuticals  Quality risk management will be set up  All stages of the manufacturing process have quality systems in place
  3. 3.  Immediate and evident benefits that the pharmaceutical companies can expect  Before entering the supply chain, variations would be fully checked to prevent any contaminants from entering  Products quality critical attributes would be better- monitored in-process  Greater checks on changes in the supply chain that may go unnoticed or the process drift  Growing dependence and risks on CMOs or manufacturing companies that make various drugs for various companies with different risks on contract would be lessened
  4. 4.  New approach is named ‘Quality by Design’ has each step characterized throughout the various processes According to Goodman  This approach has a process validation that is fragmented so that every step will be defined using an evaluation as being critical or non-critical by the manufacturers
  5. 5.  The following evaluation is used to define the steps  Defining the purpose of every step  Defining its operating range  Defining the variability impact within that operating range  Defining the process performance impact for reaching that range
  6. 6.  Fragmented approach will help to better understand and control effectively all of the processes Will also help monitor the processes more actively Answering these questions during the process phase of development may be quite costly and time-consuming
  7. 7.  Pharmaceutical companies should define critical steps  Find an acceptable range and to separate anything that can be considered critical crucial in order to scale-up successfully Helps to define range of operations clearly
  8. 8.  When operating range is weak it can lead to excessive use of materials  Ingredients used in large concentrations or affect investigations that are out-of-specification from an unknown cause Research study with total transparency would lessen the requirement for transfer of verification technology
  9. 9.  Goodman goes on to explain that process analytical technologies should be used by pharmaceutical manufacturers These include  Process controls  Process analyzers and  Tools for acquiring multivariate data Guidelines have recently been issued by the FDA that are founded on the idea of embracing todays new technologies
  10. 10.  Compliance Insight, Inc. Your Hands-On Quality and Regulatory Specialists Our services include GMP consulting, audit preparation, FDA mock inspections, FDA response assistance, vendor/contract audits, GMP training and accreditation, new construction compliance, regulatory consulting, investigations, biosafety and viral testing consulting; clinical trial audits and more. For more information visit