GMP News
22 August 2005
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Two
Recent Warning Letters for Manufacturers of Sterile Products
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Many of ECA’s latest activities touched on FDA’s new initiatives (cGMP
Initiative, CMC risk-based approach, new GMP Inspection programme). For
example in our GMP
News, dated 25 July 2005, we discussed FDA’s Pilot Risk-Ranking
Model for GMP Inspections. It seems that all these approaches are more and
more put into practice. Recently, FDA's CDER and CBER released Warning
Letters that point out to current GMP inspection trends. Subject to both
inspections were companies producing sterile and therefore high risk
products. Statements in those warning letters like "You are
responsible for evaluating whether each observation on the Form FDA 483
represents an isolated incident or a systemic problem" reference to
FDA’s system based inspection approach.
The comparison between the stated deviations and currently offered ECA
courses shows that the ECA Education Courses definitely stay ahead of
time. All critical topics which are mentioned in those warning letters are
covered by various ECA Education Courses. To fulfil the claim to
incorporate current GMP developments into all courses offered by ECA the
ECA Advisory Board members will continue to assess each course
continuously. Thus, you will receive the most comprehensive and up-to-date
GMP training by participating in the ECA GMP Certification Programme.
The FDA Warning Letter Report with a comprehensive evaluation of all
warning letters issued during one fiscal year is created every year by
CONCEPT HEIDELBERG in co-operation with the European Compliance Academy.
You can read a summary of the most important deviations in FY 2004 if
you click here.
The following table refers to the latest inspections findings and the
corresponding ECA Education Courses which will be run in the second half
of 2005.
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FDA Warning Letter Excerpt |
Corresponding ECA Education Course |
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You failed to assure that your drug product meets the applicable
standards of identity,
strength, quality, purity, and potency at the time of use by appropriate
stability testing [21
CFR 211 .137(a), 211 .166, 680.3(e), and 610.10].
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Stability Testing of Drug Substances and Drug
Products, 29 – 30
November 2005, Barcelona, Spain |
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Your firm failed to establish and follow appropriate written
procedures designed to
prevent microbial contamination of drug products … and to
assure that such procedures include validation of sterilization
processes, [21 CFR 211 .113(b)] |
Microbiological Contamination in Pharmaceutical
Production,
Barcelona, Spain, 20-21 October 2005 |
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Your quality control unit failed to review production records
to assure that no errors have occurred or, if errors have occurred,
that they have been fully investigated;…
Several observations were made on the FDA 483 regarding deficient
investigational practices at your firm:
Some batch records did not include complete information relating to
the production and control of each batch and deviation reports
were not always initiated. 21 CFR 211.192
The quality control unit did not adequately review records to assure
that no errors have occurred or, if errors occurred, that they were fully
investigated.
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GMP/FDA-compliant Batch Record
Review, Vienna, Austria, 6-7
October 2005 |
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Your firm failed to establish an adequate system for cleaning
and disinfecting the room and equipment to produce aseptic
conditions [21 CFR 211 .42(c)(1 0)(v) and 600.11(a)].
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Complying with the new FDA Aseptic
Guide, Berlin, Germany, 29-30
September 2005 |
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Your firm failed to establish an adequate system for
monitoring environmental conditions of aseptic processing areas
[21 CFR 211 .42(c)(10)(iv)].
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Complying with the new FDA Aseptic
Guide, Berlin, Germany, 29-30
September 2005 |
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Your firm failed to establish the control systems necessary
for aseptic processing operations to prevent contamination [21
CFR 211.42(c)(10) and 600.11(a)].
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Complying with the new FDA Aseptic
Guide, Berlin, Germany, 29-30
September 2005 |
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You are responsible for evaluating whether each observation on
the Form FDA 483 represents an isolated incident or a systemic
problem.
A template, which gives the same investigation procedures and
corrective actions, is not an adequate investigation.
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FDA’s New Quality Systems and Risk
Approach, Barcelona, Spain,
10-11 November 2005 |
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Please address leachables in both normal and discolored
containers in the study promised in your response.
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GMP/FDA-compliant Extractables and Leachables
Testing, Vienna,
Austria, 29-30 September 2005 |
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Sterility complaint investigation reports failed to identify and
discuss any possible correlation of the sterility test isolate
with microorganisms found in your firm’s environmental and
personal monitoring. 21 CFR 211.198 |
Microbiological Challenges for GMP/FDA Compliance –
Masterclass, Berlin, Germany, 23-25 November 2005 |
You will find all warning letters related to cGMP compliance in our
public database. Please visit www.gmp-compliance.org.
Enter a keyword below the top menu (e.g. validation, OOS) and
you will be shown the warning letters with deviations regarding the
keyword.
Author: Dr Ulrich Herber on behalf of ECA
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