Labcompliance News, January 2009
New FDA Guidance for Clinical Investigators
and Sponsors
On Jan 14 the FDA published the "Guidance for
Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting
to IRBs - Improving Human Subject Protection". It is intended to
assist the research community in interpreting requirements for
submitting reports of
unanticipated problems, including certain adverse events
reports, to the institutional review board (IRB).
Specifically, the guidance provides recommendations for sponsors and
investigators conducting investigational new drug (IND) trials
to help them differentiate between those adverse events that are
unanticipated problems that must be reported to an IRB and those
that are not. The guidance also makes suggestions about how to
make communicating adverse events information to IRBs more
efficient. The guidance can be downloaded from the
FDA website.
FDA, EU and GAMP 'Advice' on Using Excel®
Excel is frequently used in laboratories,
offices and manufacturing as sophisticated calculator.
Some companies stay away from using Excel and other spreadsheets in
FDA regulated because such Out-off-the-Box software does not comply
with all FDA requirements. However, with the necessary controls
Excel can be brought into compliance. For example, the FDA has
developed two internal Information Bulletins on developing and using
spreadsheets in regulated environments. Useful advice also is
received from FDA inspection reports. The new Annex 11 for EU GMP's
and GAMP®5 also include chapters on
Spreadsheets. To learn everything about FDA's and other regulatory
expectations and enforcement practices for using Excel
click here.
FDA Opens Three Offices in China
It had been announced since long time, but now
it happened: According to a US governmental
press release from
18 November 2008 the FDA has officially opened three offices in
China: Beijing, Guangzhou and Shanghai. Eight senior experienced FDA
officials have been selected to work in the offices in China. The
employees are inspectors and senior technical experts in foods,
medicines and medical devices. According to an article published by
GMP NEWS the inspections will focus on API manufacturers. "Whereas
during the 1980's, the major part of active pharmaceutical
ingredients was still manufactured in Europe and the USA, today it
is assumed that up to 80% of the active ingredients come above all
from China and India. What experts had suspected for many years now
seems to become apparent: Many active pharmaceutical ingredients
manufacturers in China and India are not GMP compliant and are
furthermore a starting point for counterfeits". the article states.
To read the full article,
click here.
ICH Finalizes Annex to Q8
With Principles of Quality by Design
This guideline has been released under Step 4
of the ICH process in November 2008. Q8 as originally released in
2005 is intended to provide guidance on Pharmaceutical Development
for drug products as defined in the scope of Module 3 of the Common
Technical Document (ICH guideline M4). In November 2008 ICH released
a new Annex to this guideline that provides further clarification of
key concepts outlined in the core guideline. In addition, this Annex
describes the principles of quality by design (QbD). The Annex is
not intended to establish new standards: however, it shows how
concepts and tools (e.g., design space) outlined in the parent Q8
document could be put into practice by the applicant for all dosage
forms. The Annex with the new guideline has been published on the
ICH website
New PIC/S Brochure Published
PIC/S' mission is "to lead the international
development, implementation and maintenance of harmonized Good
Manufacturing Practice (GMP) standards and quality systems of
inspectorates in the field of medicinal products. There are
currently 36 Participating Authorities
from all over the world with more on the applications list, for
example the US FDA. Some of the GMP guidelines have been signed into
local regulations of member countries and inspection guides and
joint inspection programs will help to harmonize global inspections.
Now PIS/S has published a new brochure that describes all activities
such as training programs, expert circles, and joint GMP inspection
programs.
"Incomplete Risk Analysis" Cited
in FDA Warning Letter
Risk analysis is expected to be conducted for
medical devices through FDA's Quality System Regulation 21 CFR Part
820 and for pharmaceutical and API manufacturing through the FDA
Guide: "Quality Systems Approach to Pharmaceutical CGMP
Regulations". While in the past risk analysis and risk management
was hardly enforced this seems to change now. This became
obvious through a Warning Letter for a medical device company. For
example, the letter states: "Risk analysis is incomplete. The risk
analysis for the hazard of linking PET/CT scans to the incorrect
patient was performed after an xxx incident. The risk analysis has
not been re-assessed/updated for increased probability given the
three subsequent incidents. Your firm's Standard Operating Procedure
directs risk analysis be reviewed and updated upon receipt of
safety-related complaints. However, no risk analysis was performed
for complaints related to incorrect normalization values in xxx
scanners.". The warning letter can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts (scroll down to 212).
To learn everything risk analysis and management, and to receive a
risk management master plan and SOPs,
click here
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: Handling Deviations from Standard Operating
Procedures . To download your free copy, go to the
GLP
Tutorial, scroll down and click on the corresponding ICON on the
left (offer expires on Feb 1, 2009). Labcompliance offers more than
100 SOPs. For titles and ordering, click
here.
ISO 17025 Workshop at Analytica
Vietnam
Analytica Conference
Understanding and Implementing ISO 17025
March 20, 2009, Hanoi, Vietnam
One day workshop with Dr. Ludwig Huber
Learning through examples: 50% of the time will be dedicated to
case studies
Very attractive pricing: $50, includes 10+ Best Practice Documents
New Audio Seminars - Updated Schedule
-
Requirement Management for Equipment and Computer
Systems
Strategies for Development, Documentation and Updating
Requirement Specifications
February 4, 2009
-
Validation and Use of Excel® Spreadsheets in Regulated
Environments
Comply with GxPs, Part11, HIPAA, SOX and other regulations.
February 12, 2009
New or Updated Sites