Pharmaceutical Audit

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.” Quality Assurance (QA) and independent audit is critical in the pharmaceutical industry to assure reliability of the products, adherence to approved specifications, and conformation of current good manufacturing practices (cGMP) to regulation. Manufacturers must establish a quality control unit that is responsible for quality-related activities required by the regulations. Quality is determined by whether the firm complies with GMP requirements and makes scientifically justified decisions. Pharmaceutical companies are now taking a proactive stance with the new GMP Systems approach, more effective internal auditing and increased regulatory awareness throughout the company.

 

  • Analytical method Quality Auditing
  • Quality Management System in Testing Laboratories
  • Importance of Audit in Pharmaceutical Industry
  • Quality Assurance Audits in Pharma Industries
  • Auditing Deviations, Product Complaints, and CAPA Systems
  • Goals and Strategies to Meet Audit Requirements
  • Pharmaceutical Auditing for OTC Drugs
  • Clinical and Bioanalytical laboratory Audits
  • Clinical Audit in Pharmaceutical Development
  • Sanitation and hygiene

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