How Prepared Are You? Gap Analyses, Audits, and Risk Assessments

 Written by Alexis Stroud - Manager, Regulatory Compliance at QPharma

Almost all worldwide regulatory agencies that regulate the healthcare industry, including, the European Medicines Agency (EMA), Japanese Ministry of Health (JMW), Organization for Economic Cooperation and Development (OECD), U.S. Food and Drug Administration (FDA), as well as recognized international quality standards organizations, such as the International Organization for Standardization (ISO), require that manufacturers conduct internal audits of their quality management systems on a regular basis to ensure compliance with appropriate standards and regulations. In addition, critical suppliers must be audited to ensure their systems and processes meet the appropriate standards and regulations. An effective audit system proactively identifies weaknesses in the quality system and provides the opportunity to correct and prevent these problems. An effective analysis system helps provide the company with insight into areas which could be improved. In addition, it is becoming evident that risk management, including assessment and mitigation strategies, is a valuable component of an effective quality system and should be part of your audit and analysis program. Without an effective audit and analysis program, a company is at higher risk for non conformance, regulatory action, security breaches, poor product quality, loss of certification and registration, increased product liability risk and an ineffective process improvement system.

Regulatory Significance

As recent headlines demonstrate, failure to comply with laws and regulations could cost a company millions in fines, loss of consumer confidence, decrease in stock prices and loss of business partners and investors. In addition to significant revenue losses, regulatory inspections may also lead to injunctions, consent decrees, Warning Letters, 483s (Notice of Inspectional Observations), delays or rejections of product approvals, import detentions, recalls, criminal investigations and prosecutions, seizures, compliance problems, revocation of licenses and registrations and regulatory oversight.

Recent Headlines

Don’t believe me? Check out a few recent headlines:

Baxter Could Lose $600 Million in Recall of Infusion Pumps (FDANews, June 2010)

Tylenol, Former PR Pros, May Face Criminal Charges for Recalled Meds (Newsweek, May 27, 2010)

F.D.A. Again Warns a Generic Maker About Conditions at Its Plants (The New York Times, April 15, 2010)

U.S. Attorney News Release: Stryker Biotech and Its Top Management Indicted for Illegal Promotion of Medical Devices Used in Invasive Surgeries (DOJ, October 28, 2009)

FDA slaps Apotex with import ban (FiercePharma, September 9, 2009)

FDA Debars Investigator, Study Coordinator (August 4, 2009)

FDA Issues Import Alert For 30 Ranbaxy Drugs (PharmaLot, Sept. 2008)

September 31, 2007: Bristol-Myers Squibb to Pay More Than $515 Million to Resolve Illegal Drug Marketing and Pricing Allegations (DOJ, September 28, 2007)

So let me ask again: How prepared are you for a regulatory inspection? What are some of the techniques you use to ensure you have an effective audit and analysis program?

Stay Tuned!

For more information and an in-depth look into the basics of conducting gap analyses, audits and risk assessments, keep an eye out for my article Introduction to Performing Gap Analyses, Audits, and Risk Assessments to be published in the July edition of FDA Compliance Digest.