Labcompliance News, March 2011
FDA Starts to Look for Measurement Uncertainty
One of the major differences between FDA GxP regulations and the
ISO/IEC 17025 Quality Standard has always been measurement
uncertainty. While it is a strong ISO 17025 requirement to estimate
and report measurement uncertainty, it has never been an FDA
requirement. This seems to been changing now. Not through
regulations and official guidance documents but through inspections.
Measurement uncertainty has been cited in a recent Warning Letter:
"You fail to challenge the analytical balances for minimum weight,
measurement for uncertainty, and drift value".
The Warning Letter can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to W-246.
To learn more about other inspection trends, sign up for
the
audio seminar "Learning from
Recent Warning Letters Related to GMP Laboratory Controls".
To learn everything about measurement uncertainty, attend the
audio seminar "Measurement Uncertainty in Chemical
Analysis".
New FDA Draft Guidance: Electronic Source
Documentation in Clinical Investigations
The document provides guidance to sponsors, contract research
organizations (CROs), data management centers, and clinical
investigators on capturing, using, and archiving electronic data in
FDA-regulated clinical investigations. It is intended to ensure the
reliability, quality, integrity, and traceability of electronic
source data and source records maintained at the site for FDA
inspection. This guidance is intended to promote the capture of
source data in electronic form, which will help to eliminate
unnecessary duplication of data, reduce the opportunity for
transcription errors, promote the real-time entry of electronic
source data during subject visits, and to ensure the accuracy and
completeness of data (e.g., through the use of electronic prompts
for missing or inconsistent data). The guidance can be downloaded
from the FDA website
FDA 483 for Insufficient Number of
Qualified People
The FDA expects that laboratories have
enough qualified people to do the assigned tasks.
This became obvious in a recent 483 inspectional observation
going to an OTC drug manufacturer. The letter states:
"The
number of qualified personnel
is
inadequate to perform and supervise
the
manufacture,
processing,
packing, and
holding
of each
drug
product.
According to the
Laboratory Manager, they do not have
the
staff to adequately
investigate OOS test results,
refer to observation #27 for
a
list
of OOS investigations that
were
not
timely.
In addition, the
Quality Control Manager
stated
they
need
people
to conduct all of the testing."
In addition several
observations were related to "No or in-sufficient
training for permanent and temporary
employees, non-completed method validation and non-completed formal
method transfer. The 483 can be downloaded from
the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to W-248.
To learn more about recent lab control related warning
letters and how to avoid them, sign up for
the
audio seminar "Learning from
Recent Warning Letters Related to GMP Laboratory Controls".".
USP Proposes to Update Chapter on Verification
of Compendial Methods
USP proposed revising the General Chapter <1226> "Verification of
Compendial Methods". The title has changed to" Verification of
compendial methods" and USP has a new definition for the
verification process: "The verification process for compendial test
procedures is the assessment of whether the procedure can be used
for its intended purpose, under the actual conditions of use for a
specified drug substance and/or drug product matrix.“ The new
revision leaves it open what and how much to test during the
verification process. "The process of assessing the suitability of a
compendial analytical test procedure under the conditions of actual
use may or may not require actual laboratory performance of each
analytical performance characteristic." Most interesting are a
couple of additional criteria that should be considered for the type
and extent of testing. The revision of the General Chapter
<1226> will be published in the USP 35. For more information look at
Pharmacopeial Forum
36(6).
"SOP does not Ensure Sample Integrity" cited in FDA
483
The integrity of test samples should be maintained from sampling to
sample testing. During inspections FDA check if SOPs are available
and adequate. During an inspection of an API manufacturer FDA
investigators found that there is no SOP that ensures
maintaining sample integrity throughout the testing of the sample.
The letter reads: "The SOP 'Maintenance of Integrity of Sample' is
inadequate in that it does not assure complete integrity of
documentation related to sample analysis. It specifies the
assignment of a “booking number” to each sample, but no further
procedures regarding subsequent documentation are included. Certain
elements of sample integrity are addressed in other SOPs, but none
of the procedures explicitly call for maintaining sample integrity
throughout the testing of the sample"
In addition the FDA found that "In-house
laboratory procedures for various laboratory tests were either
non-existent or inadequate" and Performance of test
methods such as loss on drying, residue on ignition, and sulfated
ash was not adequately documented.
The Warning Letter can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to W-247.
To learn more about recent lab control related warning
letters, sign up for
the
audio seminar "Learning from
Recent Warning Letters Related to GMP Laboratory Controls".
73 New Documents in the Labcompliance Usersclub
We have added 73 new documents to the Labcompliance Usersclub. They
include 14 new SOPs, 20 examples for practical validation and
compliance including checklists . 10
forms/templates, 3 important FDA presentations and 22 recent FDA
warning letters/483's related to GMP/GLP or GCP. To see the new
titles,
click
here.. User club members can instantly
download the new additions. To see the complete list and
ordering the users club,
click
here, and scroll down to 'new additions'. With these additions,
the Usersclub has more than 500 documents ready for download.
Can Vendors Offer 'FDA Compliant' or "Part 11
Compliant" Software?
With FDA's increasing focus on computers and Part 11 during
inspections companies want to do a good job in preparation and
software suppliers . User companies with little understanding of the
regulations prefer to purchase "Part 11 compliant" or 'FDA approved
software" which is advertized by some vendors. Already 10 years ago
in the early days of Part 11 the question has been discussed
whether vendor can deliver such software. Advice came from FDA
officials at conferences and industry trainings. For an example and
recommendations from Labcompliance
click here.
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 "Risk assessment for Laboratory Systems".
To download your free copy, go to the
Laboratory Compliance Package website. Scroll
down and click on the corresponding ICON on the left (offer expires
on April 1, 2011).
Labcompliance offers more than 120 SOPs that help to comply with FDA
and ISO 17025 compliance. For titles and ordering, click
here.
Conference
Analytica Vietnam, Hoh Chi Minh
City, Vietnam, April 7-9, 2011
April 8: Full day Workshop by Dr. Ludwig Huber
Validation of Analytical Methods for FDA and EU Compliance
Audio Seminar Schedule
-
Learning from Recent Warning Letters Related to GMP Laboratory
Controls
For Preparation of FDA and International GMP Laboratory
Inspections
Recorded, available on demand
-
Auditing Computer Systems for Part 11 and Annex 11
Compliance
Prepare your organization for upcoming FDA and EU inspection
Recorded, available on demand
-
Validation and Use of Excel® Spreadsheets in Regulated
Environments
Comply with FDA Part 11, the PIC/s Good Practice Guide and the
EU Annex 11
Recorded, available on demand
-
Developing a Risk Management Master Plan
A must for efficient and consistent implementation of risk
management projects
Recorded, available on demand
New or Updated Sites