Labcompliance News, January 2011
New EU GMP Annex 11 on Computerized Systems Released
On Jan 3, 2011, EU has released a new final version of
Annex 11. Together with the updated EU GMP Chapter 4 on
documentation it is the EU equivalent to FDA's Part 11. Compared to
the older version l it has more detailed some very specific
requirements. It addresses the regulatory needs of modern IT
equipment and when implemented right, also has business benefits
through reduced failure rates. The document is a good framework for
validation and using computer systems and handling electronic
records in different regulated environments. On the other hand it
leaves a lot of room for interpretation that raises lots of
questions. Attend the new Labcompliance
audio seminar to learn everything about the new Annex 11 and
receive 10+ best practice for easy implementation.
FDA’s GLP regulations, part 58 (21 CFR part 58), were finalized on
December 22, 1978 (43 FR 60013). This regulation prescribes good
laboratory practices for conducting nonclinical laboratory studies
that support or are intended to support applications for research or
marketing permits for products regulated by FDA, including food and
color additives, animal food additives, human and animal drugs,
medical devices for human use, biological products, and electronic
products. The conduct of nonclinical laboratory studies has changed
markedly since issuance of this regulation in 1978, for example,
laboratories have expanded the use of electronic technology, both
for laboratory instrumentation and as a means for collecting,
storing, and reporting study data. Current part 58 does not
specifically describe these modern arrangements and advances.
Therefore the FDA considers
revising Part 58, and also applies FDA's current interpretation
for inspections. Revising a regulation can be a long process and
take several years. In the meantime inspections are going on.
To learn everything about current FDA GLP inspection
practices and inspection findings,
attend the
audio seminar "Learning from Recent Warning Letters
Related to Good Laboratory Practices".
For the analysis of stability test samples validated stability
indicating methods should be used that are appropriate determining
and monitoring impurity profiles. Unexplained discrepancies, for
example, non-identified co-eluting compounds should be investigated.
This was stated in an FDA Warning Letter to an API manufacturer. The
letter reads: "The stability assay test chromatograms for Tiger
Balm, lot (3 and 6 months stability at temperature of 30°C),
contained co-eluting peaks. These tests and results were approved
without investigation by your quality control unit. Specifically,
during the HPLC analysis, the capsaicin peak (peak of interest) was
observed co-eluting with an unknown peak, while a second large
unknown peak was also present in front of the capsaicin peak. In
your response to this letter, provide the updated validation reports
of both assay methods, including the specificity studies performed
to demonstrate that both assay methods are stability indicating and
appropriate for determining and monitoring impurity profiles". Other
deviations included: Sampling not representative, supplier test
results not verified, incomplete laboratory records, lab notebooks
not controlled and reviewed, stability samples not properly
controlled, stored and maintained.
The Warning Letter can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to W-245.
To learn everything about FDA compliant development,
validation and use of stability test methods,
attend the
audio seminar "Development and Validation of
Stability Indicating Methods".
USP Pharmacopeial Forum (PF) now for Free
PF is the bimonthly online journal through which USP develops and
revises standards for the United States Pharmacopeia and the
National Formulary (USP–NF) by a process of public review and
comment. Changes and additions to USP–NF standards are first
proposed in PF to invite public comment..To encourage and broaden
participation in the standards-setting process, USP transitioned PF
from a subscription-based print and online publication to a free,
online-only resource with the release of PF 37 (1) on January 3,
2011. To sign up, click
here.
Number of GLP Warning Letters and Number of
Deviations Increasing
The number of FDA warning letters following GLP study inspections is
increasing. An example is a recent warning letter following an
inspection that was part of FDA’s Bioresearch Monitoring Program to
verify compliance with 21 CFR 58. The warning letter lists 9
deviations. Examples include: Personal did not understand the
functions they are to perform, reports not signed by individuals,
articles not tested for stability, no SOP for sterile preparation of
dosing solutions, study director failed to follow applicable GLP
regulations, inadequate validation of bioanalytical methods, QA
failed to maintain a master schedule, SOPs not followed without
justification, equipment not adequately cleaned, inspected and
maintained, inadequate corrections of final reports. The warning
letter has detailed examples for all deviations.
The Warning Letter can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to W-244. To
learn everything about FDA GLP inspections and inspection
findings,
attend the
audio seminar "Learning from Recent Warning Letters
Related to Good Laboratory Practices".
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 "Validation of Software and computer
systems for ISO 17025". To download your free
copy, go to the
ISO/IEC Accreditation Package website. Scroll
down and click on the corresponding ICON on the left (offer expires
on Feb 15, 2011).
Labcompliance offers more than 120 SOPs that help to comply with FDA
and ISO 17025 compliance. For titles and ordering, click
here.
Audio Seminar Schedule
-
Learning from Recent Warning Letters Related to Good Laboratory
Practices
For Preparation of FDA and International GLP Inspections
Recorded, available on demand
-
Understanding and Implementing the New EU Annex 11
Learn about specific requirements and get tools for
implementation
Recorded, available on demand
New or Updated Sites