Labcompliance News, February 2010
FDA Launches a new
Risk-Assessment Tool for Better Drug and Food Import Control
On February 4, 2010, Commissioner Hamburg
announced the launch of a new risk-assessment tool to ensure the
safety of imported food and drugs. The web-based PREDICT system will
rank the risk hazards of food and drugs as they enter the country
and allow inspectors to focus on the most likely threats to public
health. PREDICT will assist entry reviewers in targeting higher-risk
shipments for examination. It will also expedite the clearance of
lower-risk cargo, but only if accurate and complete data are
provided by importers and entry filers. To see FDA's press release,
click here.
ICP Systems for Metal
Impurity Analysis Must be Part 11 Compliant
USP has proposed several standards for
analysis of metal impurities in raw material, drugs and food. ICP-MS
and ICP-AES are recommended as analytical techniques. These are
computerized systems that should comply with Part 11. This became
obvious from an FDA warning letter. The letter states: "The computer
software your firm uses to determine metals analysis is deficient.
It has no security measures to prevent unauthorized access of the
software, no audit trails, and data can be copied or changed at
will, with no documentation of the copying or changes". FDA also
makes it clear that users of such systems should be trained: "There
is no documentation to indicate that analysts are trained in the
software and its applications". Furthermore, the company was cited
for not documenting computerized raw data, and for repeat testing of
OOS products without first conducting an investigation. The Warning
letter can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to
W-058. Learn more about analysis of metal impurities according
to the proposed USP standard in the Labcompliance
audio seminar.
USP Changes Dissolution
Performance Verification Tests
Since Dec 1, 2009, the Performance
Verification test (PVT) using Salicil acid Tablets RS is no longer
required for USP apparatus 1 and 2. The tests using the Prednisone
Tablets RS tablets for USP Apparatus 1 and 2 and Chlorpheneramine
Maleate Extended-Release Tablets RS for USP Apparatus 3 are still
required. Also beginning December 1, 2009, the change in General
Chapter <711> removing the requirement for individual tablet tests
for the PVT became official. This is not a change in the PVT
procedure or criteria. The chapter will instead rely on the
Technical Data Sheet provided with the particular lot of RS to
provide the acceptance criteria. This change to <711> allows USP,
via the Technical Data Sheet, to move from acceptance criteria for
the individual tablet results to a new set of criteria at a later
date, For the complete article,
click here.
"OOS of Stability Chambers
not Investigated" Draws FDA Warning Letter
The temperature and humidity of stability
chambers need to be well controlled. Deviations from accepted limits
should be investigated. FDA cited a pharmaceutical company in New
Jersey for not investigation an OOS situation: "Out-of-specification
(OOS) humidity levels for the controlled room temperature stability
chamber were noted on January 27, March 17, and April 5 and 6, 2009.
Investigations and corrective actions were not conducted at the time
to address these out-of-specification results". Other deviation
included: 'Variation in the amount of components for preparation of
dosage forms not justified and documented' and 'Stability indicating
test methods not followed'. The Warning letter can be downloaded
from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to
W-229. Learn more about analysis of metal impurities according
to the proposed USP standard in the Labcompliance
audio seminar.
FDA Publishes New Guidance
for Calibration of Dissolution Apparatus
This guidance is intended to aid drug
manufacturers in calibrating U. S. Pharmacopeia (USP) Dissolution
Apparatus 1 and 2 to help assure that critical parameters associated
with the dissolution apparatus meet certain mechanical calibration
(MC) tolerances. This guidance recommends that an enhanced MC
procedure can be used as an alternative to the current Apparatus
Suitability procedure for Dissolution Apparatus 1 and 2 described in
USP General Chapter <711> Dissolution.. To download the guidance,
click here.
FDA Warning for Data
Manipulation
During a recent inspection of an API
manufacturer inspectors uncovered manipulation of quality control
test records. Computerized printed IR spectra have been manipulated
by the analyst, most likely to bring an OOS result into
specification: "Your firm's laboratory analyst had modified printed
raw data related to the IR Spectra test of (b)(4) and (b)(4). We are
concerned that the lack of security or system controls allows for
this practice." Furthermore the company was cited for the
Quality Control Unit not being able to detect the manipulation. The
Warning letter can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to
W-230. Even though Part 11 has not been mentioned this is just
an other example how the FDA enforces Part 11. To learn everything
about FDA's new Part 11 strategy and enforcement practices, attend
the Labcompliance
audio seminar "FDA's New Enforcement of Part 11".
Free Document of the Month
As a 'Thank You' for our visitors
Labcompliance offers every month one document for free. This month's
document is the SOP: Subcontracting of Test and Calibration. To
download your free copy, go to the
ISO 17025 Accreditation Package website. Scroll down and
click on the corresponding ICON on the left (offer expires on
February 20, 2010). Labcompliance offers more than 100 SOPs that
help to comply with FDA and ISO 17025 compliance. For titles and
ordering, click
here.
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