Regulatory Authority Compliance

With more stringent compliance parameters set by the USFDA the quality assurance of pharmaceutical products is ensured. In addition to cGMP, GLP and GCP practices as per the US Federal law pharma products should comply with 21CFR regulations. Also on a regular basis the FDA organizes compliance programs for the pharma industries in program areas like Biologics (CBER), Bioresearch Monitoring (BIMO), Devices/Radiological Health (CDRH), Drugs (CDER), Food and Cosmetics (CFSAN), Veterinary Medicine (CVM). The results of regulatory audits NAI – No Action Indication, VAI – Voluntary Actions Indicated, OAI – Official FDA Action Indicated are also critical to decide by auditors in regards to compliance matters and call for several challenges to overcome by the manufacturers.

 

  • Food and Drug Administration (FDA)
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Therapeutic Goods Administration (TGA)
  • Central Drug Standard Control Organization (CDSCO)
  • Health Canada
  • European Medicines Agency (EMEA)

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