Good Manufacturing Practices: The Gap within

Good Manufacturing Practice is the part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization or product specification. Good Manufacturing practices conference aims at both production and QC. Current Good Manufacturing Practices (cGMP) is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products. FDA regulates the quality of pharmaceuticals very carefully. Current Trends in the FDA is the main regulatory standard for ensuring pharmaceutical quality.

Current FDA guidelines are useful for maintaining standards by ensuring quality of the products. GMP for OTC and Cosmetic products is also necessary to ensure consumers that the products they take are safe and effective. Good Automated Manufacturing Practice (GAMP) is a system for producing quality equipment using the concept of prospective validation following a life cycle model which is specifically designed to aid suppliers and users in the pharmaceutical industry. GMP Quality Audits are necessary for assessment of self-inspection in the regulatory aspects of GLP/GCP interface.

  • Facts about current good manufacturing practices (cGMPs)
  • Good automated manufacturing practice (GAMP)
  • FDA good manufacturing practices
  • GMP/GCP interface & GMP audits
  • GMPs for OTC and cosmetic products – global requirements
  • GMPs for medical devices
  • GMP requirements & standards
  • Pre-clinical and clinical studies
  • Regulatory submission and correspondence
  • Accelerating drug approval timelines
  • Clinical trials in emerging markets

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