Labcompliance News, November 2007
November 13, 2007
GAMP® Good Practice Guide: Electronic Data Archiving
This Guide provides a rational and scalable approach to
electronic data archiving through the development of an archiving
strategy. The implementation of such a strategy should assist
organizations to achieve and maintain regulatory compliance, and to
more effectively manage electronic records over the long term. The
new guide can be ordered as bound book from ISPE's
On-line Store. It is also available as PDF file for immediate
download from
Techstreet/Thompson Scientific
Labcompliance has conduced an audio seminar
"Cost Effective
Electronic Archiving for FDA Compliance". The seminar has been
recorded and is
available on CD with all Q&As and 10+ Best Practices.
November 15, 2007
FDA Advices on Investigating OOS Test Results
Edwin Rivera, Chief Investigations and Preapproval Compliance
Branch at CDER US FDA gave a very detailed presentation at the 31st
international GMP conference in Athens, Georgia. He started with on
overview of FDA inspection findings over the last year This
information included top 10 CGMP deviations, top 5 citations and top
3 laboratory and production deviations. He continued the
presentation with a brief overview on the history and scope of FDA's
final OOS guidance. Then he explained FDA's expectations for
laboratory and full investigations. The presentation has 55 slides
and gives very detailed advice. For example, Mr. Rivera made it
clear that QCU should provide oversight of laboratory
investigations. He also gave examples when averaging tests results
is acceptable. The presentation is included in the reference
material of the Labcompliance audio seminar:
Managing OOS, failure
investigations and CAPA.
November 19, 2007
Canadian Digital Information Strategy Published
Long term archiving and retrieval of digital data is a concern
worldwide for industry but also for public organizations. Therefore
industry and public organizations develop guidelines and strategies.
A recent example is the Digital Information Strategy published by
the Canadian Library and Archives organization. The strategy focuses
on preservation of the information but also on maximizing access and
use. The document is quite interesting, since we have not seen any
country with such a broad national program, and its reference list
is both useful and up-to-date. To download the 63 pages paper,
click here. Labcompliance has conduced an audio seminar
"Cost Effective
Electronic Archiving for FDA Compliance". The seminar has been
recorded and is
available on CD with all Q&As and 10+ Best Practices.
November 19, 2007
The Method Validation Tutorial is Back
The popular Method
Validation Tutorial has been updated and is now available for
Labcompliance visitors. It should help to get a good understanding
on USP, ICH, EMEA and FDA requirements and strategies for
initial validation, for transferring methods and for verification of
compendial methods. The tutorial includes
- A primer with basic information and recommendations for
implementation.
- Expert advice on selected topics
- Links to warning letters, 483's and/or establishment
inspection reports
- Literature references
- Links to other websites
November 20, 2007
New EMEA Guideline for Stability Testing
The Committee for Medical Products for Veterinary Use (CVMP) has published a
draft guideline on "Stability Testing of Existing Active Substances and Related
Finished Products". deadline for comments is April 30, 2008. The earlier version
of the guideline EMEA/CVMP/846/99 was revised to be brought in line with the
requirements of the Note for Guidance on Stability Testing of New Veterinary
Drug Substances and Medicinal Products (EMEA/CVMP/VICH/899/99-Rev.1). As a
consequence, the relative humidity at storage under intermediate conditions,
i.e. presently 30°C ± 2°C/60%RH ± 5%RH, will be changed to 30°C ± 2°C/65%RH ±
5%RH. Within the EU, data from studies generated using the new conditions are
accepted immediately. Furthermore, data from studies where the relative humidity
has been changed from 60%RH to 65%RH during the study to meet the new
requirements will also be accepted under the condition that the respective
storage conditions and the date of the change are clearly documented and stated
in the application file. It is recommended that all marketing authorization
applications contain data from complete studies at the intermediate storage
condition 30°C ± 2°C/65%RH ± 5%RH, if applicable, by <3 years after final
adoption of the revised guideline>.
The draft guideline is available for download on the
EMEA website.
November 20, 2007
FDA Warning Letter Issued for Incomplete GLP Study Report
FDA regulators inspected the GLP facility between on Dec 6-22, 2006 as part
of FDA's Bioresearch Monitoring Program and found practices that did not conform
with U.S. FDA requirements Violations included: failure of the study director to
assure that all experimental data were accurately recorded and verified and to
document the reason for any change in the entries, for example, the study
director failed to assure that dosing were accurately recorded to confirm that
study animals received protocol-specified doses of the vehicle. In addition QAU
failed to assure that reported results in the final study report accurately
reflected the raw data. Furthermore, the company was cited for failing to
identify the test and control articles with appropriate characteristics in the
final report and to adequately test, calibrate, and/or standardize all equipment
used the generation, measurement and assessment of data. The Warning Letter can
be downloaded from the Labcompliance
Usersclub. (Scroll down to 193). Non members can
preview
excerpts.
November 20, 2007
Article on MHRA Inspection Findings
This article published by the Pharmaceutical Journal (PJ) reports the nature
and frequency of serious deficiencies in compliance with Good Manufacturing
Practice (GMP) and Good Distribution Practice (GDP) found on regulatory
inspections by the Medicines and Healthcare products Regulatory Agency (MHRA)
during the year 2004–05. It covers industrial manufacturing and distribution
sites in the UK, manufacturing sites in third countries and sites where the NHS
is the licence holder. Data for the years 1996–97, 1998–99 and 2001–02 were
published previously. The paper also reviews reports of defective medicines
received by the MHRA’s Defective Medicines Report Centre (DMRC) and drug alerts
issued in 2005 to support recalls issued by the relevant importers,
manufacturers and marketing authorization holders. The article is not new but
reading the data is interesting. Data from 2006-07 are not available yet. As of
Nov 2007 the article is available on the
PJ
website. Copyright resides with the publisher.
November 20, 2007
API Manufacturer Cited for Incomplete Batch Records and Poor
Laboratory Practices
The inspections from April 207 revealed significant deviations from U.S.
Current Good Manufacturing Practice (CGMP) in the manufacture of Active
Pharmaceutical Ingredients (API). Deviations have been: Incomplete batch
records, insufficient documentation of method validation, and inadequate
documentation of laboratory equipment calibration. For example, batch production
records did not include complete information relating to the production and
control of each API batch, method validation documentation did not include
appropriate data to verify that the analytical method produced accurate and
reliable data, production equipment was not adequately cleaned and was not
maintained in a good state of repair and laboratory equipment calibration was
not adequately documented.
The letter also stated that any future shipments of APIs manufactured at the
company's Kun Tai Road site (Old Site) will be denied entry into the United
States. The letter further stated the the ICH CGMP Guidance "Q7A Good
Manufacturing Practice Guidance of Active Pharmaceutical Ingredients" describes
current good manufacturing practice (CGMP) for manufacturing of APIs. Although
the ICH CGMP Guidance does not impose requirements, FDA considers its
recommendations, as well as alternatives intended to accomplish the same goals
and provide an equivalent level of quality assurance, in determining whether a
firm's APIs have been manufactured, processed, packed, and held according to
current good manufacturing practice. The Warning Letter can be downloaded from
the Labcompliance
Usersclub (Scroll down to 193). Non members can
preview
excerpts