Regulatory affairs and requirements

Regulatory affairs and requirements Photo

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

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