Labcompliance News, April
2009
FDA Releases Final ICH
Guidance Q10
The US Food and Drug Administration has
released ICH Q10 'pharmaceutical quality Systems' as final FDA
guidance. This guidance applies to the systems supporting the
development and manufacture of pharmaceutical drug substances (i.e.,
active pharmaceutical ingredients (APIs)) and drug products,
including biotechnology and biological products, throughout the
product lifecycle. ICH Q10 describes one comprehensive model for an
effective pharmaceutical quality system that is based on
International Organization for Standardization (ISO) quality
concepts, includes applicable good manufacturing practice (GMP)
regulations, and complements ICH “Q8 Pharmaceutical Development” and
ICH “Q9 Quality Risk Management.” ICH Q10 is not intended to create
any new expectations beyond current regulatory requirements.
Consequently, the content of ICH Q10 that is additional to current
regional GMP requirements is optional. The Guidance can be
downloaded from the
FDA website.
Brazilian New GMP's Rely on
EU Annex 11 for Regulating Computerized Systems
In January this year ANVISA (Agência Nacional
de Vigilância Sanitária), the Brazilian equivalent of the US FDA,
published a new draft GMP regulation with several Annexes. Annex 5
regulates the use of computers in GMP environments. It looks
like an abbreviated version of the new Annex 11 to the European GMPs
that has been published as draft about a year ago. 18 out of
the 19 chapters in Annex 11 have equivalent chapters in ANVISA's
Annex 5. Chapters include risk management, personnel, validation,
system documentation, quality assurance of software development,
data processing, user testing, security, audit trails and others.
Most interesting is a statement that for complex systems, e.g.,
databases, chromatography, process control) inspectors should be
able to access and study electronic system records of paper
printouts. Annex 11 covers all aspects of using computers and with
FDA's ongoing delay of the new Part11, it could become the global
GMP standard for using computers. To get copies of the ANVISA
document in English, to learn everything about the new Annex 11 and
to get 10+ best practices tools for implementation,
click here.
New FDA Guidance on
Pharmacopoeial Texts - Sterility Test
The Food and Drug Administration announced in
a Federal Register notice of February 17, 2009, the availability of
a draft guidance entitled ``Q4B Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the ICH Regions; Annex 8: Sterility
Test General Chapter.'' The draft guidance was prepared under the
auspices of the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human
Use (ICH). The draft guidance provides the results of the ICH Q4B
evaluation of the Sterility Test General Chapter harmonized text
from each of the three pharmacopoeias (United States, European, and
Japanese) represented by the Pharmacopoeial Discussion Group (PDG).
The guidance can be downloaded from the
FDA website.
'Advice' from the FDA on Part 11
in an Establishment Inspection Report
FDA establishment inspection reports are quite
useful because inspectors provide an objective inspection protocol.
Most interesting is information on what has been inspected, what the
inspector's questions have been and how the regulated company did
comply. An example is a cGMP inspection report of a mammalian cell
culture contract manufacturing facility. Inspected areas and systems
included quality, equipment, materials, production, packaging and
labeling and laboratory controls. No FDA-483 was issued but in
the management meeting at the end inspectors gave recommendations
for improvements related to Part 11, electronic
records, computer validation, cleaning verification, media fills,
and environmental monitoring. For example: "Issues
pertaining to electronic records and signatures related to the
firm's computer systems should be resolved in compliance with 21 CFR
Part 11. Activities and assessments including upgrades to the
current system should be completed with high priority. Drawings
should be controlled. e.g., stamped signature and date"and 'More
specific diagrams or locations for environmental monitoring sampling
plans should be provided" The 14 page EIR with
more recommendations can be downloaded from the
Labcompliance Usersclub. Non
members can
preview excerpts (scroll down to 216).
FDA Presentation: Writing An
Effective 483 Response
Anita Richardson, Associate Director for Policy, at the FDA
Office of Compliance & Biologics Quality, gave a presentation at a
pharma conference on "Writing An Effective 483
Response". Ms. Richardson covered three areas: 1) Regulatory
framework and FDA policies and procedures for the FDA 483; 2)
Reasons for submitting a well-reasoned, complete, and timely 483
response; and 3) Eight suggestions for an effective 483 response. It
became clear that with well written timely response could possibly
mitigate an FDA compliance decision for further action, e.g.
untitled letter, Warning Letter.
The warning letter can be downloaded from the
Labcompliance Usersclub. Scroll down to G-229. For information
and registration to the Usersclub,
click
here.
"Computer System not Maintained
in Validated State" Cited in FDA Warning Letter
Computerized systems should be maintained in
validated state and reviewed. This became obvious in a recent FDA
warning letter. The letter reads: "Your firm failed to
maintain computerized systems in a validated state. The inspection
team noted that this automated system, containing formulas and
recipes for buffers was programmed in 1999 and has not been reviewed
or updated. We are concerned that other discrepancies in other
values may exist. Please comment on how you will assure all values
programmed into the automated system, and other automated systems,
are consistent with current master batch records." In addition the
letter mentioned other deviations, e.g., "No adequate monitoring of
bioburden" and "Written procedures for equipment maintenance not
followed" The warning letter can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts (scroll down to 215).
To learn everything risk analysis and management, and to receive a
risk management master plan and SOPs,
click here
PIC/S Publishes Inspection
Guide for APIs
The guide, officially called AIDE
MOMOIRE,should provide training and guidance to GMP Inspectors not
specialized in the inspection of API manufacturers. The guide should
also contribute to a harmonized approach for inspections of
API manufacturers between the different PIC/S Members. While this 24
page document has been developed for PIS/S inspectors is also a good
tool for API manufacturers to be used in preparation for internal
audits and for pharmaceutical companies for auditing API suppliers.
The guide can be downloaded from the
PIC/S website.
Brazil is Becoming a Top
Emerging Pharmaceutical Market
Pharmaceutical companies are advised to pay
attention to Brazil.
Stable economics and growing healthcare concerns make Brazil one of
the top emerging pharmaceutical market, In 2008, the Brazilian
pharmaceutical market was estimated to reach US$ 14.9 billion, 34%
of Latin America, jumping 23% from 2007. The market is controlled by
the National Health Surveillance Agency (ANVISA), created in 1999,
which is the equivalent of the US FDA.
ANIVISA just published a modern draft GMP with
seven detailed Annexes for public review. The US
Pharmacopeia has recognized the value of the Brazilian market by
opening its fourth overseas location (after Switzerland, India and
China) in Sao Paulo in August 2008.
The full article has been published by
Pharmaceutical Commerce and as of
April 2009 is available on the publishers website. Copyright rests
with the publisher.
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: Archiving and Retrieval of GMP Data and other
Documents.To download your free copy, go to the seminar page
Raw Data in FDA Regulated Environments (209)
,
Scroll down and click on the corresponding ICON on the left (offer
expires on May 12, 2009). Labcompliance offers more than 100 SOPs
that help to comply with FDA and ISO 17025 compliance. For titles
and ordering, click
here.
Meet FDA's John Murray at the Annual IVT
Computer System Validation Conference
John Murray, computer validation and Part 11
expert of the FDA speaks about "Conducting a Regulatory Review of
Computer Software Validation (CSV)". During the three day
conference practitioners from pharmaceutical industry will provide
case studies and tool kits that make it easy to implement
recommendations from the FDA and industry leaders.
10th Annual Software and Computer System Validation
May 18-20, 2009, Sheraton National Hotel • Arlington, VA
Three day IVT conference with plenary lectures,
workshops and interactive discussion sessions.
Free Webinar: Automating Spreadsheet Controls for
21 CFR Part 11 Compliance
Join Prodiance and compliance and validation expert
Dr. Ludwig Huber for this exclusive online event to learn about
the key risk and compliance issues for spreadsheets in the
pharmaceutical lab environment, and how the latest technology from
Prodiance can help organizations improve compliance with FDA
mandates while mitigating operational risk and driving productivity
gains.
April 30,
2009
New Audio Seminar Schedule
-
Traceability in Chemical Analysis
With strategies and tools for ISO 17025 and FDA Compliance
April 30, 2009
-
Effective Verification of Compendial Methods
Understanding USP and FDA Requirements and get Tools for
Implementation
May 14, 2009
-
Auditing Laboratories for FDA and ISO 17025 Compliance
Preparation - conduct - follow up - documentation
June 18, 2009
-
Managing Out of Trend Results in Pharmaceutical
Manufacturing and Quality Control
Comply with the FDA and international guidances
July 9, 2009
New or Updated Sites