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Interview: FDA Inspection Readiness

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Interview: FDA Inspection Readiness

 

Business Intelligence Solutions Interview

with Jack Garvey

FDA INSPECTION READINESS

 

March 2010

What are the biggest issues currently facing FDA-regulated companies when it comes to FDA inspections?

FDA regulated companies are currently dealing with a multitude of challenges.  Initially, companies have been aware of the reduction in FDA enforcement rigor that has occurred over the last 8 to 10 years, and many companies have, as a result, let their guard down with respect to FDA inspection readiness.   Also, as result of significant economic challenges, companies have had to do more with less.   Since companies had been observing that their overall enforcement risk had been reduced, there was no real incentive to ensure robust quality and compliance programs and as a result, quality and compliance staffing has often been either frozen, or reduced.   I’m aware of one leading pharmaceutical / medical device manufacturing company that eliminated a significant portion of its corporate quality and compliance oversight function a few years ago, and, not surprisingly, is now experiencing problems within the organization.    Unfortunately, when times are tough, executives often look at the cost of these functions, and fail to remember how important the quality and compliance roles are to ensure companies aren’t devastated by an adverse legal / regulatory enforcement action.

As a result of the new FDA Commissioner, Margaret Hamburg, are you seeing an increase in inspection intensity and frequency?

FDA has, as most people know, been slowly increasing the quantity, intensity, an overall rigor of its inspection activities with respect to FDA regulated companies.  In August of last year, FDA commissioner Hamburg outlined in the first Commissioner’s speech to deal exclusively with enforcement, FDA’s new approach to aggressive enforcement activities, and their desire to “streamline” the enforcement process.   So far, it appears that enforcement activity is increasing slowly, but steadily.   It is likely that the Obama administration has so many issues on its plate that FDA enforcement, and product safety, have not yet received the attention that they would have under normal circumstances.   I would expect that eventually, significant attention will be placed on supply chain security and product safety, and inspection and enforcement action will increase substantially.

What are the areas and issues that are creating the most risk for companies in the current environment?

There are many, many issues that are currently of concern for FDA-regulated companies, and that create real risk.   Initially, despite years of clear knowledge of FDA regulations and expectations, many companies have simply not fully implemented robust quality and compliance systems.   I find that many companies  just don’t know what they don’t know.   They are under the assumption that their systems are fine, and that things are “in control”, when nothing could be further from the truth.   These companies are the ones at most risk from the increasing level of FDA enforcement.   Even if FDA does not increase the level of intensity and quantity of inspections , it is already far less cooperative with companies that just “don’t get it” and/or that have a history and track record of substandard compliance activities.

For companies that have generally embraced proper approaches to compliance and quality management over the years, the traditional areas of concern will continue to be areas of intense scrutiny by the FDA.    Perennial favorite CAPA can most assuredly be considered one of the most important quality subsystems to have fully prepared (and objectively assessed) before getting a review during an FDA inspection.   FDA’s focus on external supply chain security, and offshore and outsourced operations, place companies that perform much of their operations through third parties at an increased risk.   These companies must have a robust oversight program in place to ensure that the company is fully aware of the actions of their third-party provider, and that all the requirements and responsibilities (including controlled change, investigations, etc.) of the provider are being executed.    Finally, companies can expect FDA to review your process/product knowledge (or characterization) and how this knowledge is being used to drive proper CAPA investigations, recall decisions, change management, validation, and the design of your process control frameworks.

 

In light of the foregoing, what would you recommend companies do to prepare for their next FDA inspection?

Since companies within the US are subject to FDA inspections without notice (even though they generally follow a rough anticipated schedule), they need to be what I call “ever ready” for an FDA inspection.   This state of readiness ensures that a company can quickly mobilize when an FDA Investigator walks through the door, and that they can readily provide access to, and explain their systems, procedures, practices, products and quality records that the FDA will be looking for.   Also, this state of readiness should be reinforced by company executive management through periodic walkthroughs with knowledgeable individuals.   The benefit of this is that with a little effort, it can show that the executives team is committed to a high state of readiness and the importance of excellent inspection outcomes.

Companies outside the US are somewhat more fortunate since they receive prior notice prior of the occurrence of an FDA inspection.   However, these companies shouldn’t become too complacent – there is often far too much work and change to get done within the typical month between notice and inspection to truly prevent significant inspection observations.

As part of an “ever ready” approach to inspection readiness, companies should have a number of things “in place” at all times (at a minimum) ready to review with an Investigator when they walk in the door.    These include:

  • A copy of their inspection procedure(s);
  • A binder of their Quality Manual (or equivalent) and an index of their Policies, SOPs, Work Instructions, Guidances, Standards and / or other documents that comprise their quality system documentation;
  • An “introductory presentation” about the company, its products, the site, the manufacturing areas, the leadership team, and the processes the Investigator will be looking at;
  • A binder of at least five complete years of regulatory inspection documentations, including 483s (if any), EIRs, Warning Letters (if any), full responses to 483s and Warning Letters, and a complete index of commitments and documentation of commitment completion.

There are many, many more things that a company can do to prepare for the inevitable inspection, including performing CAPA record reviews, process control plans, and develop advocacy-based messaging to substantiate quality system decision making.     As the saying goes, “in time of peace, prepare for war,” and nothing could be more relevant today for FDA-regulated companies.

For further information on FDA Inspection Readiness, contact Jack Garvey at john.garvey@compliancearchitects.com, or call 888-734-9778.

Audits, Assessments & Corporate Compliance Investigations

Although audits, assessments and corporate compliance investigations are not something most executives get excited about, they are critical to ensuring your FDA-regulated business is ready for any and all types of review by the FDA, Department of Justice or other regulator.  Audits, Assessments, Corporate Compliance Investigations and (one additional item) Mock Inspections are generally defined as follows:

  • Audit: A formal, often-privileged, structured, in-depth review of a company’s regulated operation for the purpose of determining deficiencies and deviations from established and understood regulatory standards. Audits are often “scored” for purposes of determining performance of an operation against accepted standards.
  • Assessment: A formal, not-privileged, and loosely structured review of a company’s regulated operation for purposes of determining issues, deviations from regulatory standards, opportunities for improvement, best practices and readiness for audit or inspection.
  • Corporate Compliance Investigation: A for-cause investigation, generally performed at the direction of the Company CEO, General Counsel, or Chief Compliance Officer, possibly subject to privilege if authorized and executed properly, and focused on confirming, or disproving, allegations of illegal conduct or violations of a company’s code of conduct, procedures, policies or other mandates. Corporate compliance investigations must conform to the highest standards of critical review to ensure discretion, confidentiality, comprehensive assessment and legal analysis are performed properly.
  • Mock Inspection: An audit performed by someone posing as an FDA Investigator for the purposes of determining operational readiness for a real FDA or other health authority inspection. Mock Inspections are both a readiness and training tool and provide significant value to an organization when performed properly.

Each of the foregoing can vary in intensity and rigor in accordance with the needs of the organization. Depending on the amount of time spent, each of these can be more or less rigorous (and correspondingly more or less expensive) depending on what level of risk and confidence each organization possesses.

For small and medium-size organizations seeking to proactively assess compliance, Compliance Architects® recommends a three-day review activity. For medium to large size organizations seeking to proactively assess compliance, we recommend a week to two-week review activity. Where corporate compliance investigations are indicated, specialized planning and cooperation with the Chief Executive and counsel are typically indicated.

For additional information on audits, assessments and investigations, contact Jack Garvey at john.garvey@compliancearchitects.com, or visit:  www.compliancearchitects.com

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