Current GMP Guidelines (cGMP) & GxP in Pharmaceuticals

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the US FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.

The purpose of the GxP quality guidelines is to ensure a product is safe and meets its intended use. GxP guides quality manufacture in regulated industries including food, drugs, medical devices and cosmetics.

 

  • Pharmaceutical cGMPs for the 21st Century
  • EU-GMP guidelines (European union-GMP guidelines)
  • WHO-GMP guidelines (World health organization-GMP guidelines)
  • GMP for active pharmaceutical products
  • GMP for biopharmaceuticals
  • cGMP quality principles for biologics and biotechnological products
  • Licensing in pharmaceutical production & GMP documentation
  • Issuance and retrieval of GMP records
  • Cancellation of GMP records
  • Good Documentation Practice (GDP)
  • Role of GxP in medical and food industries
  • Good Engineering Practice (GEP)
  • Good Auditing Practice (GAP)
  • Good Review Practice (GRP)
  • Role of GxP and c GxP in biopharmaceutical Industry

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