Quality Assurance Audits in Pharma Industries

The quality of pharmaceuticals has been a concern of the World Health Organization (WHO) since its inception. The setting of global standards is requested in Article 2 of the WHO Constitution, which cites as one of the Organization’s functions that it should “develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products.” The supply of essential medicines of good quality was identified as one of the prerequisites for the delivery of health care at the International Conference on Primary Health Care in Alma-Ata in 1978. Similarly, the Conference of Experts on the Rational Use of Drugs, held in Nairobi in 1985, and WHO’s Revised Drug Strategy, adopted by the World Health Assembly in May 1986, identified the effective functioning of national drug regulation and control systems as the only means to assure safety and quality of medicines.

 

  • Good manufacturing practices for pharmaceutical products (GMP)
  • Sanitation and hygiene
  • Good practices in production
  • Quality management in the drug industry
  • FDA CDER and CBER review
  • Speed Biologics development
  • Global trend for Biologics
  • Regulating regenerative medicine
  • Cosmetics
  • CTD, eCTD

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Quality Assurance Audits in Pharma Industries Conference Speakers