Current GMP Guidelines (cGMP)

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.

GMP for active pharmaceutical products are required so that all manufacturing processes are clearly defined, systematically reviewed for associated risks. GMP for biotechnological products and GMP for biopharmaceuticals are intended to serve as evidence that the manufacturing process changes will not have an adverse impact on the quality, safety and efficacy of the drug product. Licensing in pharmaceutical production is given only after doing pre-audit, post- audit of the area to ensure proper surveillance. CGMP Quality Principles for Biologics and Medical Devices are required to maintain product compliance.

  • 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

Related Conference of Current GMP Guidelines (cGMP)

Current GMP Guidelines (cGMP) Conference Speakers