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:

August 18-19, 2025

40th World Congress on Pharmacology and Therapeutics

Valencia, Spain
August 27-28, 2025

20th World Congress on Drug Formulation & Drug Delivery

Amsterdam, Netherlands
September 19-20, 2025

18th World Drug Delivery Summit

Paris, France
September 22-23, 2025

Pharma Biotech Expo

Toronto, Canada
September 23-24, 2025

10th International Conference on Future Pharma and Innovations

Amsterdam, Netherlands
September 24-25, 2025

5th World Congress on Rare Diseases & Orphan Drugs

Aix-en-Provence, France
October 23-24, 2025

21st Annual Meet on Pharmaceutical Sciences

Aix-en-Provence, France
November 11-12, 2025

6th Annual Congress on Antibiotics and Bacterial Infections

Amsterdam, Netherlands
November 13-14, 2025

21st International Conference on Pharmaceutical Chemistry

Aix-en-Provence, France
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
November 27-28, 2025

13th International Conference on Clinical Trials

Amsterdam, Netherlands
February 23-24, 2026

3rd World Congress on Biologics and Biosimilars

London, Aland Islands
April 27-28, 2026

9th European Biopharma Congress

Paris, Aland Islands

Importance of Audit in Pharmaceutical Industry: Conference Speakers

    Recommended Sessions

    Related Journals

    Are you interested in