Labcompliance News, March 2009
New FDA Guidance on
Anticancer Pharmaceuticals.
The Food and Drug Administration announced in
a Federal Register notice of February 17, 2009, the availability of
a draft guidance entitled ``S9 Nonclinical Evaluation for Anticancer
Pharmaceuticals.'' The draft guidance was prepared under the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 The draft guidance provides recommendations for
nonclinical studies for the development of pharmaceuticals,
including both drugs and biotechnology-derived products, intended to
treat patients with advanced cancer. The recommendations describe
the type and timing of nonclinical studies to support an
investigational new drug application (IND) and the submission of a
new drug application (NDA) or biologics license application (BLA).
The guidance can be downloaded from the
FDA
website.
New Primer on Analytical
Instrument Qualification and System Validation for Free
Agilent Technologies offers a 67 page primer
on Analytical Instrument Qualification and Laboratory Computer
System Validation. This primer written by Dr. Ludwig Huber, guides
analysts, laboratory managers, quality assurance managers and IT and
validation professionals through instrument and system validation at
minimal extra cost. Following a literature and regulatory overview,
this primer provides information on the entire qualification and
validation process from planning, writing specifications as well as
vendor qualification to installation, initial and on-going
operation. Special focus is placed on getting a good understanding
of and implementing USP chapter <1058>. After an introduction to the
chapter’s approach for instrument qualification and system
validation, this primer will lead you through individual
qualification phases and give recommendations for implementation.
For more information and ordering the free printed primer ,
click here
FDA Takes Regulatory Action
Against Ranbaxy’s Plant in India
The U.S. Food and Drug Administration
announced that a facility owned by India-based Ranbaxy Laboratories
falsified data and test results in approved and pending drug
applications. The facility, Paonta Sahib, has been under an FDA
Import Alert since September 2008. To address the falsified data,
the FDA has invoked its Application Integrity Policy (AIP) against
the Paonta Sahib facility. The AIP is invoked when a company’s
actions raise significant questions about the integrity of data in
drug applications. Under the AIP, the FDA has asked Ranbaxy to
cooperate with the agency to resolve the questions of data integrity
and reliability. This would include implementing a Corrective Action
Operating Plan (CAOP) to provide assurance of the integrity and
reliability of data from the Paonta Sahib facility. To read the full
article,
click here
Requirements of ISO 17025
for Computer Systems
There is a frequent question on how software
and computer systems should comply with the ISO/IEC 17025
accreditation standard. The answer is written in the standard
itself. For example the standard has 33 clauses that reference to
computers, either directly or indirectly. Most of them are short and
need further interpretation for implementation. Laboratories should
have a clear general procedure on using computers in ISO 17025
environment. In addition procedures should be available for specific
task such as validation, back-up, and secure authorized access to
systems and data The effort to bring software into compliance
depends on the software category and on the impact the system has on
the test results. Attend the new Labcompliance
audio seminar to learn what to do for different software
categories and get necessary procedures for easy implementation.
President Barack Obama
Announces New FDA Commissioner
In his weekly address,
President Barack Obama announced the appointments of Dr. Margaret
Hamburg as Commissioner of the Food and Drug Administration, and Dr.
Joshua Sharfstein as the Principal Deputy Commissioner, as well as
the creation of a new Food Safety Working Group. Dr. Hamburg is a
nationally and internationally recognized leader in public health
and medicine, and an authority on global health, public health
systems, infectious disease, bioterrorism and emergency
preparedness. In addition to the creation of a new Food Safety
Working Group, the President also announced two other measures to
protect the American people.
New FDA Guidance on
Pharmacopoeial Texts - Dissolution Test
The Food and Drug Administration announced in
a Federal Register notice the availability of a draft guidance
entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts
for Use in the ICH Regions; Annex 7: Dissolution 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
Dissolution 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.
Readability Problems with 10
Year old PDF Files?
During a one day seminar on March 3, 2009
about Raw Data in Regulated Environments long term archiving and
retrieval of electronic records has been discussed. When PDF as
archiving format was suggested, a seminar attendee from a global
pharmaceutical company reported readability problems with 10 year
old PDF files using current reader software. Needless to say that
this can cause big problems when working in regulated environments.
Look at the recent Labcompliance
audio seminar to learn about several
alternatives and to get procedures for recording, long term
archiving and retrieval in regulated environments.
New FDA Guidance on
Pharmacopoeial Texts - Uniformity of Dosage Units.
The Food and Drug Administration announced the
availability of a draft guidance entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions;
Annex 6: Uniformity of Dosage Units 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
Uniformity of Dosage Units 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.
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 Validation Example: Requirements Specifications for
HPLC Systems . To download your free copy, go to the seminar
page
Understanding the New USP <1058> for Analytical Instrument
Qualification (192),
scroll down and click on the corresponding ICON on the left (offer
expires on April, 2009). Labcompliance offers more than 100 Examples
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
New Audio Seminar Schedule
-
Management and Validation of Computers for ISO 17025
Requirements, Recommendations and Tools for Implementation
April 8, 2009
-
IT Infrastructure and Network Qualification
Introduction and Strategies for Compliance and System Uptime
April 23, 2009
-
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