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:

February 14-15, 2023

8th Pharmaceutical Chemistry Conference

Paris, France
February 20-21, 2023

20th Annual Meet on Pharmaceutical Sciences

Rome, Italy
March 10-11, 2023

Global Pharmaceutical and Pharma Industry Conference

Brussels, Belgium
March 13-14, 2023

33rd Annual European Pharma Congress

Frankfurt, Germany
March 27-28, 2023

16th Global Pharmacovigilance & Clinical Trials Summit

Vancouver, Canada
April 03-04, 2023

16th European Biosimilars Congress

Barcelona, Spain
April 25-26, 2023

4th Annual Congress on Antibiotics and Bacterial Infections

Amsterdam, Netherlands
May 07-08, 2023

Advanced-Materials 2023

Valencia, Spain
July 25-26, 2023

36th World Congress on Pharmacology

Amsterdam, Netherlands
August 11-12, 2023

38th World Congress on Pharmacology and Therapeutics

Singapore City, Singapore
August 28-29, 2023

23rd International Pharmaceutical Conference and Expo

Vancouver, Canada
September 06-07, 2023

16th World Drug Delivery Summit

London, UK
September 14-15, 2023

10th international conference on Physiotherapy

Bangkok, Thailand
September 27-28, 2023

3rd World Congress on Rare Diseases & Orphan Drugs

Amsterdam, Netherlands
September 27-28, 2023

8th International Conference on Future Pharma and Innovations

Amsterdam, Netherlands
October 09-10, 2023

20th International Conference on Pharmaceutical Chemistry

Barcelona, Spain
October 12-13, 2023

26th World Congress on Nursing, Pharmacology and Healthcare

Budapest, Hungary
November 09-10, 2023

11th International Conference on Clinical Trials

London, UK
November 10-11, 2023

3rd World Biosimilars & Biologics Congress

Berlin, Germany
December 05-06, 2023

2nd World Congress on Precision and Personalized Medicine

Zurich, Switzerland

Importance of Audit in Pharmaceutical Industry: Conference Speakers

    Recommended Sessions

    Related Journals

    Are you interested in