Labcompliance News, February 2011
The EU Annex 11 Can Become Important for FDA
Regulated Industry
The first version of Annex 11 been originally published in 1991 as
an Annex to the Pharmaceutical Inspection Convention/Cooperation
Scheme (PIC/S) GMP. The first EU GMP Annex 11 was published in 1993.
A draft of an updated version was published in 2008 and the final
update in January 2011. The current version is very much complete
and in junction with the updated EU GMP Chapter 4 on Documentation
it provides a complete information on managing computerized systems
in regulated environments. There is a good chance that the current
version will be published by PIC/S again as an official GMP Annex.
Considering that now the US FDA is a member of PIC/S and that
the FDA does not have an equivalent document (Part 11 is much less
complete) it may well be that US field investigators will use the
new Annex as some kind of an inspection guide. From
recent FDA warning letters with citations about back-up,
contingency planning and configuration management it became clear
that FDA is looking beyond the requirements of Part 11 with its
focus on electronic records and signatures. Attend the new
Labcompliance
audio seminar to learn everything about the new Annex 11 and
receive 10+ best practice for easy implementation.
Laboratory equipment should be checked on a regular basis to verify
adequate performance for the intended application. During the
inspection of an API manufacturer the FDA found several instruments
that either have not been qualified at all or important tests were
missing. The letter reads: "Your HPLC calibration lacks a carry over
test (sample injection residual test), sample energy (intensity of
light source), and lamp use hours determination. You fail to
challenge the analytical balances for minimum weight, measurement
for uncertainty, and drift value. In addition, you do not calibrate
the Karl Fisher syringe used during xxx API water content analysis.
In addition the company failed to
adequately reprocess
API batches,
to thoroughly investigate complaints for
API, for not using USP acceptance
criteria. and for not maintaining equipment re-qualification
raw-data.
The Warning Letter can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to W-246.
To learn more about recent lab control related warning
letters,
attend the
audio seminar "Learning from
Recent Warning Letters Related to GMP Laboratory Controls".
Laboratory Controls #1 Deviations in FDA GMP
Inspections
FDA has published a hit list of deviations found in international
GMP inspections in fiscal year 2010. With almost 19% (including
deviations related to unvalidated lab test methods) laboratory
controls ranked as number 1, far ahead to quality systems (9%) and
production&process control systems (6%). A further breakdown shows
that deviations related to lab controls are highest in China with
28%, Europe is about average with 18% and India below average with
13%. Equivalent numbers are not available from US but based on
individual analysis they are expected to be in the same range as
Europe. We at Labcompliance are not surprised about this trend.
Several times we have reported about FDA's increased focus on GMP
lab inspections and also gave several examples for lab related
deviations in FDA 483's and warning letters. To
learn everything about FDA GMP lab inspections and laboratory
inspection findings,
attend the
audio seminar "Learning from
Recent Warning Letters Related to GMP Laboratory Controls"
and get access to 20 examples warning letters and to the related
full FDA statistics.
USP Publishes the new Chapter <1224> for Analytical
Method Transfer
In Oct 2009 USP had published a Stimuli article “Transfer of
Analytical Procedures". Based on comments received, USP now proposes
a new general information chapter <1224>. The procedure-transfer
process focuses on qualifying the receiving laboratory to perform an
analytical procedure that was developed and validated in another
laboratory within the same or in a different organization. One of
the major differences to the stimuli paper chapter is that <1224>
suggests a risk based approach for type and extent of transfer
activities, e.g., for comparative testing. The intended chapter
<1224> has been published as a
Pharmacopeial Forum
article that can be downloaded free of charge.
To learn everything about the new intended chapter,
attend the
audio seminar "Transfer of Analytical Procedures According
to the New USP <1224" and receive SOPs, templates and
examples for easy implementation.
FDA Warning Letter for Inadequate Transfer of
Analytical Methods
The FDA expects that transfer of
analytical methods should follow a documented
procedure and chemists in the receiving
laboratory should formally trained . This became obvious
during a recent FDA inspection which resulted in a 483 with 24
observations. Several observations were related to inadequate method
validation and transfer. For example: "The analytical method has not
been transferred between the issued laboratory and the two chemists
currently working in the QC laboratory. The methods have been
transferred before the two chemists were hired. There are no records
which document training in the two procedures". The 483 can be
downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to
W-241. To learn everything about FDA requirements for
analytical method transfer attend the
audio seminar "Transfer of Analytical Procedures According
to the New USP <1224".
FDA Publishes the Final Version of the Process
Validation Guidance
On the January 25, 2011, the FDA published the final version of the
industry guidance: Process Validation: General Principles and
Practices. . This guidance outlines the general principles and
approaches that FDA considers appropriate elements of process
validation for the manufacture of human and animal drug and
biological products, including active pharmaceutical ingredients
(APIs or drug substances), collectively referred to in this guidance
as drugs or products. This guidance incorporates principles and
approaches that all manufacturers can use to validate manufacturing
processes. There are no big changes in the final version compared to
the draft from November 2008. The guidance can be downloaded from
the
FDA website.
FDA Part 11 Inspections Starting with Delay
Last year in July the FDA has announced to start a specific Part 11
inspection initiative in the 4th quarter of 2010. The main purpose
of the program is to check how the industry complies with Part
11. The outcome of the initiative will be used to decide on how to
proceed with Part 11. Because of administrative reasons the start of
the program has been delayed until beginning of February. Now each
routine FDA inspection under CDER includes an evaluation of computer
systems and electronic records and specific Part 11 inspections will
be set up based on a company's compliance history. Sign up for the
audio seminar "How
to Prepare Yourself for FDA's New Part 11 Inspection Program
to learn what the FDA is looking for and how to avoid 483's
and warning letters.
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 "Electronic Audit Trail: Specifications,
Implementation and Validation". To download your
free copy, go to the
Part 11 Compliance Package website. Scroll
down and click on the corresponding ICON on the left (offer expires
on March 1, 2011).
Labcompliance offers more than 120 SOPs that help to comply with FDA
and ISO 17025 compliance. For titles and ordering, click
here.
Conferences
-
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
-
Understanding and Implementing the New EU Annex 11
Learn about specific requirements and get tools for
implementation
Recorded, available on demand
-
Transfer of Analytical Procedures According to the New
USP Chapter <1224>
With SOPs, templates and examples for easy implementation
Recorded, available on demand
-
Learning from Recent Warning Letters Related to GMP Laboratory
Controls
For Preparation of FDA and International GMP Laboratory
Inspections
Recorded, available on demand
New or Updated Sites