FDA Compliance Help Desk, Inc.

FDA GMPs - Quality Assurance

 

 

FDA Video - Quality System Regulations - Basic Introduction (105 minutes)

 

FDA Compliance Help Desk staff will "roll up their sleeves" and work with you to assure cost effective compliance and the best quality assurance in the following areas:

 

GMPs Defined (devices)

  1. Determining the appropriate quality system needed to control design, production and distribution

  2. Designing products and processes (independent review)

  3. Training employees

  4. Acquiring adequate facilities

  5. Purchasing and installing processing equipment

  6. Drafting the master record noting how to change the master records

  7. Procuring components and materials

  8. Producing the products

  9. Labeling the products

  10. Evaluating finished products

  11. Packaging

  12. Distributing

  13. Processing complaints and analyzing service and repair data

  14. Servicing

  15. Auditing and correcting deficiencies in the quality system

  16. Preparing for an FDA inspection

It's the Law

 

 

 

 

 

 

 

 

FDA GMP [Good Manufacturing Practices] requirements set forth in the Quality System (QS) regulation are promulgated under section 520 of the Food, Drug and Cosmetic (FD&C) Act.  FDA GMP requires that domestic or foreign manufacturers have a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States.  FDA GMP requires that various specifications and controls be established for devices; that devices be designed under a quality system to meet these specifications; that devices be manufactured under a quality system; that finished devices meet these specifications; that devices be correctly installed, checked and serviced; that quality data be analyzed to identify and correct quality problems; and that complaints be processed. Thus, the QS regulation helps assure that medical devices are safe and effective for their intended use. The Food and Drug Administration (FDA) monitors device problem data and inspects the operations and records of device developers and manufacturers to determine compliance with the GMP requirements in the QS regulation.

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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 Services.