Importance of Audit in Pharmaceutical Industry:

International Organization for Standardization (ISO) 9000 requirements do not have the same status of “the law” in the U.S. as do requirements listed in the Code of Federal Regulations (CFR). Because 21 CFR 210 and 211 have legal status, the U.S. Justice Department has extensive powers to ensure compliance. For example, product in the marketplace can be seized, fines can be levied, and personal liability can be assigned. So, management must understand that auditing must be taken seriously, and the requirements listed are just that – requirements. While audits are the common place in the pharmaceutical industry, the preparedness for those events varies. The companies that develop a risk-based approach to audits are able to remain competitive while meeting quality and government compliance standards on a regular basis. Conversely, the companies that have not implemented strong processes are putting themselves at risk for non-compliance. According to the Federal Food, Drug and Cosmetic Act, “Registered domestic drug establishments shall be inspected by the FDA at least once every two years.” Under some conditions the inspections may be even more frequent, As regulations become more stringent, regulatory authorities are likely to step up audits which is even more reason for companies to be prepared.

 


 


  • Quality control plans
  • The Audit as a Quality Control Mechanism
  • Adequate supervisory control
  • Proper administration of a benefit plan

Related Conference of Importance of Audit in Pharmaceutical Industry:

November 20-21, 2025

21st Annual Congress on Pharmacology and Toxicology

Paris, France
November 27-28, 2025

4th World Congress on Precision and Personalized Medicine

Zurich, Switzerland
November 27-28, 2025

4th World Conference on Pharma Industry and Medical Devices

Zurich, Switzerland
December 01-02, 2025

13th International Conference on Clinical Trials

Vancouver, Canada
January 29-30, 2026

19th World Drug Delivery Summit

Paris, France
February 10-11, 2026

40th World Congress on Pharmacology and Therapeutics

Barcelona, Spain
February 23-24, 2026

3rd World Congress on Biologics and Biosimilars

London, UK
March 23-24, 2026

36th Annual European Pharma Congress

London, UK
March 24-25, 2026

11th International Conference on Future Pharma and Innovations

Amsterdam, Netherlands
April 16-17, 2026

19th European Biosimilars Congress

Rome, Italy
April 27-28, 2026

9th European Biopharma Congress

Paris, Aland Islands
May 28-29, 2026

3rd International Conference on Pharmacognosy

Madrid, Spain
July 27-28, 2026

39th World Congress on Pharmacology

Rome, Italy

Importance of Audit in Pharmaceutical Industry: Conference Speakers

    Recommended Sessions

    Related Journals

    Are you interested in