GMP, GCP and Quality Control

Good Manufacturing Practice is that 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 Quality Control . Fact about 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, Patent AccessIntellectual property & FDA Regulations.

GMP, GCP & Quality Control is intended to provide guidance regarding good manufacturing Practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess. In this manufacturing is defined to include all operations of receipt of materials, production, packaging, repackaging, labelling, relabeling, quality control, release, storage And distribution of APIs and the related controls. In this Guide the term “should” indicates recommendations that are expected to apply unless shown to be inapplicable or replaced by an alternative demonstrated to provide at least an equivalent level of quality assurance. For the purposes of this guide, the terms “current good manufacturing practices” and “good manufacturing practices” are equivalent.

  • Facts About Current Good Manufacturing Practices (cGMPs)
  • Current GMP guidelines
  • Good clinical practices & Good Laboratory Practices
  • Current regulations and quality Standards
  • International Regulatory Affairs

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GMP, GCP and Quality Control Conference Speakers

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