The following information is abstracted from our reprint, When Things Go Wrong, Part I: The Consequences of Noncompliance. This article originally appeared in BioPharm Magazine in August 2000, with permission to reprint given by Advanstar Communications.
The following information is not intended to be all-inclusive. Please consult with your company’s quality assurance and regulatory compliance executives, as well as review the appropriate regulation.
If your company has an approved New Drug Application (NDA) or Abbreviated New Drug Application for a generic product (ANDA), and you discover a quality problem and/or a failure of distributed product to meet its specifications, you must notify your local FDA district office within 72 hours (3 days). This is called a field alert, and it is necessary even though at that point you will not have concluded your investigation. (For full requirements, please see 21 CFR 314.81).
Biologic product companies, including those processing blood products, are required to file a similar Biological Product Deviation Report (formerly called an Errors and Accident Report) to CBER headquarters in a timely fashion as well (for full requirements, see 21 CFR 600.14). 21 CFR 600.14 applies to licensed manufacturers, and requires prompt notification to CBER of errors and accidents in manufacturing that affect the safety, purity, and potency of the product(s).
Device manufacturers have a similar requirement to file a Medical Device Report (MDR), for defects or errors that may result in device-related death, serious injury, and/or malfunction (for full requirements, please see 21 CFR 803). Many representatives of the U.S. Food and Drug Administration have stated in several, recent industry meetings that they are aware that companies either under-report the above, or do not report at all (at the very least, they do not report in a timely fashion).
The same problem of under-reporting or non-reporting
occurs with the timely filing of Adverse Event Reports, and
warning letters have been issued to this effect. These are
regulatory and ethical requirements. If you are ever suspect the
to file such a notification, rapidly consult with your company’s
affairs executive, quality assurance executive, and/or with a qualified
regulatory consultant. The status of products in commercial
distribution (and human
clinical trials) must be addressed promptly.
The information on this page is provided free-of-charge for downloading, photocopying, and using in your classes or department meetings. The reprinting, transmission, or distribution for sale or use in a for-fee conference or course of this information is expressly prohibited. If you download the material, please ensure that the following copyright statement appears prominently on the bottom of each page downloaded:
Copyright 2010, Immel Resources LLC,
Petaluma, CA USA, (707) 778-7222, firstname.lastname@example.org.