FDA Compliance Help Desk, Inc.

Compliance Q & A

Q: Does FDA compliance apply?

• If your firm makes or distributes a human or veterinary drug, medical device, food, cosmetics, or supplies a firm that does; FDA compliance may apply. 
  • For example, if your firm is a machine shop and you make screws for hardware stores and a small number of screws under contract for a surgical tray manufacturer, your firm may be required to comply.
  • If your firm makes yarn that is made into a product for which your firm controls performance therapeutic claims, your firm may be required to comply with FDA regulations.
  • The answers are in the Congressional Federal Register (CFR) 21 and FDA guidance documents.

Q: Why hire an experienced and knowledgeable FDA regulatory compliance specialist?

• Cost effective compliance to FDA regulations is best accomplished with a strategic approach.  Regulations should be viewed as a set of guidelines, not as absolute statements of requirements.
  • If a firm simply follows the published regulations and guidelines to the letter without taking a creative posture, the firm's compliance cost will be too high.
  • If a firm assigns in-house staff, with limited experience,  to define the compliance strategy the potential cost of non-compliance can be staggering.
• The best approach is to minimize the total cost of compliance by developing the optimal compliance strategy.  Creativity, hands-on operating experience, and a commitment to professional excellence are key to addressing the regulatory risk depicted in figure 1:

Figure 1 Source: FDA Compliance For The Life Sciences, Olin Thompson, August 2003.

Q: What is involved in a quality system audit?

• The Help Desk uses the FDA's 108 page guide to inspections of the quality system which defines the audit techniques to be used.  For more information follow this link:

•  Quality system audits are generally established on a one or two year cycle.

Q: What are the key elements of a compliance strategy?

• Formulating a FDA compliance strategy is a critical first step.  Fragmented approaches add to the total cost and create gaps in the compliance program structure.  A cross-functional team approach is the best way to develop a winning strategy.  The FDA compliance program must addresses the following issues, to list a few:

   

  • Quality―defining the minimum non-value added work to assure product safety and prevent FDA warning letter observations.  The strategy includes defining the optimal balance of Automation vs. Human Capital.

  • Legal―for difficult compliance issue special legal counsel should be part of the strategy development team.

  • Production―compliance impacts capacity, efficiency, and budgets.

  • IT―it is cost critical for regulatory compliance issues to be considered first when evaluating the IT plan, IT and FDA compliance when integrated can reduce compliance cost.

  • Finance―compliance cost should be measured and controlled.

  • Marketing―in the 21st century compliance will increasingly become a supplier selection criteria, it can mean the difference between winning and losing key business.

  • Procurement―compliance starts with the vendors.

  • Inventory―environmental control, lot code traceability, and more.

  • Distribution―tracking and recall capability.

  • Customer Service―customer contract review, complaint handling, FDA reporting, recall capability, and more.

  • Facilities―storage and environmental control.

  • Maintenance―equipment qualification and process validation is an important part of compliance.

   

• Top management must decide:

Is your staff seasoned enough, creative enough, and willing to take a reasonable amount of risk that is required to develop an optimal regulatory compliance strategy? 

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FDA Compliance Help Desk™

1289 N. Fordham Blvd. Suite A-128

Chapel Hill, NC 27517 USA

Phone 919.942.1634

info@FDAcomplianceHelp.com

Copyright © 2004 - 2005 FDA Compliance Help Desk, Inc.
Last modified: October 16, 2005

FDA Compliance Help Desk, Inc. is a for profit NC corporation and is not affiliated with the U.S. Department of Health and Human Service.