Transcript Aftermath of Hurricane Katrina National Capital Area Environmental

ASQ Keynote
February 13, 2006
 A Look Back at 2006
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The year of the hurricane
Organizational Change
National and District
Changes in programs
Adverse Drug Experience
A Look at Today
FDA celebrates 100 years
Program changes
Increase in Atlanta District high risk firms
Resource Changes
A Look ahead
Budget Submission for 07
Resource necessitated changes
1
New Content & Format of Labeling for
Human Rx Drugs and Biological Products
 First revision in 25 years
 Applicable for new and recently approved
products
 Specific graphical requirements and
reorganization of critical information to enable
physicians to find the information quickly
2
New Content & Format of Labeling for
Human Rx Drugs and Biological Products
 Highlights : provides immediate access to the
most important prescribing information about
benefits and risks
 Table of Contents : easy reference to detailed
safety and efficacy information
 Date of initial product approval making it easy to
determine how long the product has been on the
market
 Toll-free number and Internet reporting
information for suspected adverse events to
encourage more widespread reporting of
suspected side effects
3
Top 10 Atlanta Turbo Cites
Drugs, Devices, Biologics, BIMO
CITE DESCRIPTION
CFR REFERENCE
Documentation – general
General
21 CFR 820.75(a)
21 CFR 820.75(a)
Investigations of discrepancies,
failures
21 CFR 211.192
Quality Audits conducted
21 CFR 820.22
Cleaning/maintenance records not
kept
21 CFR 211.67 (c)
Procedures, finished devices
21 CFR 820. 80 (d)
Management Responsibility
21 CFR 820.20
Maintained and followed
21 CFR 606.100 (b)
Environmental Control
21 CFR 870.70 (c)
Scientifically sound laboratory
controls
21 CFR 211.160 (b)
Top 10 Atlanta Turbo Cites
Drugs
CITE DESCRIPTION
CFR REFERENCE
Investigations of discrepancies, failures
21 CFR 211.192
Cleaning/maintenance records
21 CFR 211.67 (c)
Scientifically sound laboratory controls
21 CFR 211.160 (b)
GMP Training Frequency
21 CFR 211.25 (a)
Valid stability test methods
21 CFR 211.166 (a) (3)
Control procedures to monitor and
validate performance
21 CFR 211.110 (a)
Items to cover on annual reviews
21 CFR 211.180 (e) (2)
Second Person sign off
21 CFR 211. 194 (a) (8)
Yield calculations not verified by 2nd
person
21 CFR 211.103
Expired drugs
FDCA 501(a)(5)
Top 10 Atlanta Turbo Cites
Ties for Number 10
CITE DESCRIPTION
CFR REFERENCE
Tests Methods
21 CFR 211.165(e)
Failing drug products not
rejected
21 CFR 211.165(f)
Written program not followed
21 CFR 211.166(a)
Prepared for each batch, include
complete information
21 CFR 211.188
Laboratory equipment calibration 21 CFR 211.194(d)
records
6
DRUG RECALLS – FY 05
 CLASS I - 17
 CLASS II - 316
 CLASS III - 169
7
DRUG RECALL – FY 05
 Class 1 (11 Rx / 6 OTC)
 Class II (267 Rx / 49 OTC)
 Class III (123 Rx / 46 OTC)
8
REASONS FOR RECALL
 CGMP DEVIATIONS (144)
 FAILED DISSOLUTION TEST
REQUIREMENTS (57)
 MICROBIAL CONTAMINATION OF NONSTERILE PRODUCTS (31)
 LACK OF EFFICACY (25)
 IMPURITIES/DEGRADATION PRODUCTS
(19)
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REASONS FOR RECALL
 LACK OF STERILITY ASSURANCE (18)
 PRODUCT STABILITY (16)
 LABELING ERROR/DECLARED
STRENGTH (13)
 MISBRANDED/PROMOTIONAL
LITERATURE CLAIMS (13)
10
TIE FOR TENTH
 LABELING ISSUES (MISCARTONED OR
MISPACKED (12)
 SUBPOTENT – SINGLE INGREDIENT
DRUG (12)
 SUPERPOTENT –SINGLE INGREDIENT
DRUG (12)
11
HELP NEEDED
 Check if sending to right District
 Identify NDA/NDA/BLA number of application,
firm name and name of drug on cover of file.
Beware of paper clips
 Name of District firm identified.
 Fasteners/overfill
 Contact for listing of active applications