Labcompliance News, June 2009
Harmonization Steps Move
Forward in Yokohama, Japan
The International Conference on Harmonisation
(ICH) Steering Committee and its expert working groups met in
Yokohama from June 6 - 11, 2009. A significant milestone was
achieved with the finalization of the revision of the M3 Guideline
"Non-clinical Safety Studies for the Conduct of Human Clinical
Trials and for Marketing Authorizations". The new M3 Guideline
promotes more rapid discovery and development of innovative
medicines, by reducing the reliance on animals required in drug
development studies. These efforts continue ICH's commitment to the
3Rs (Reduction, Refinement and Replacement) of animal testing.
Progress was made on the harmonization of pharmacopoeial texts in
the three regions, which will reduce testing requirements for the
industry. To read the full ICH press release,
click here.
FDA Data Standards Council
Launched New Website
The FDA Data Standards Council
coordinates the evaluation, development, maintenance, and adoption
of health and regulatory data standards to ensure that common data
standards are used throughout the agency. The new site has links to
other FDA sites with specific information on data standards for
selected applications, for example, Structured Product Labeling,
Regulated Product Submission, Stability Data Standard and others. To
visit the site,
click here
New FDA Guidance on
Regulatory Submissions in Electronic Format
The Food and Drug
Administration announced in a Federal Register notice of June 1,
2009, the availability of a guidance for industry entitled
‘‘Providing Regulatory Submissions in Electronic Format—Drug
Establishment Registration and Drug Listing.’’ This guidance
document is designed to assist industry (e.g., manufacturers,
repackers, and relabelers) with the electronic submission of drug
establishment registration and drug listing information.
Specifically, the document provides guidance to industry on the
types of information to include for purposes of drug establishment
registration and drug listing and on how to prepare and submit the
information in an electronic format that FDA can process, review,
and archive. The guidance can be downloaded from the
FDA Website
New FDA Guidance on Research
or Radioactive Drugs
The Food and Drug
Administration announced in a Federal Register notice of June 3,
2009, the availability of a draft guidance for industry and
researchers entitled ‘‘The Radioactive Drug Research Committee:
Human Research Without An Investigational New Drug
Application. This draft guidance provides information to those using
radioactive drugs for certain research purposes to help determine
whether research studies may be conducted under an FDA-approved
radioactive drug research committee, or whether research studies
must be conducted under an investigational new drug
application(IND). It also offers answers to frequently asked
questions on conducting research with radioactive drugs, and
provides information on the membership, functions, and reporting
requirements of a radioactive drug research committee approved by
FDA. The guidance can be downloaded from the
FDA website
"Failure Investigation not
Extended Outside the Lab " Cited in FDA Warning Letter
FDA requires for OOS failure investigations to
determine if corrective and preventive actions are necessary. The
root cause of the OOS result should be determined, if necessary,
outside the laboratory. This became obvious in a warning letter to
an API manufacturer. The letter reads: "Failure of your
investigations of out-of-specification results to determine if
corrections or preventive actions are needed. Your firm failed to
continue its investigation of the OOS results outside of the
laboratory in order to determine the cause of the results."
Furthermore the FDA letter recommends "Any OOS result obtained
should be investigated and documented according to a procedure. This
procedure should include analysis of the data, assessment of the
extent and cause of the problem, allocation of the tasks for
corrective actions, and conclusions." The warning letter can be
downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts (scroll down to 209).
To learn everything about FDA compliant handling of failure
investigations, Out-of-specification and Out-of-trend test results,
attend the upcoming
audio seminar
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 qualification and system
validation at minimal extra cost. 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
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: Validation of Spreadsheet Applications (for
example; Excel Spreadsheets). To download your free copy, go to the
Computer System Validation Package website. Scroll down
and click on the corresponding ICON on the left (offer expires on
July 12, 2009). Labcompliance offers more than 100 SOPs that help to
comply with FDA and ISO 17025 compliance. For titles and ordering,
click
here.
New Audio Seminar Schedule
Managing Out of Trend Results in Pharmaceutical Manufacturing and
Quality Control
Comply with the FDA and international guidances
July 9, 2009
Understanding and Implementing ISO 17025
Requirements, Strategies and Tool Kits for Laboratory
Accreditation
July 23, 2009
Successful FDA Inspections
Preparation - Conduct - Follow Up
July 30, 2009
New or Updated Sites