Labcompliance News, July 2007
July 27, 2007
New FDA Guide on Analytical Method Transfer
On April 26, 2007, the FDA a new final industry guidance
entitled: Protocol for the Conduct of Method Transfer for Type C
Medicated Feed Assay Methods. This guidance provides recommendations
for protocols for conducting the transfer validated methods to
laboratories that have no experience with the test method. The guide
recommends steps for the controlled transfer and has examples for
testing. It also includes an appendix with an example protocol.
Although the guidance has been developed for medicated feed assay
methods its concepts and recommendations are equally important for
other applications. FDA's expectations for a controlled transfer of
analytical methods and various options for compliance have been
discussed in recent
Labcompliance audio seminar that has been recorded and is
available with all reference material. The guidance can be
downloaded from the
FDA website.
July 27, 2007
FDA Update on 21 CFR Part 11
George Smith, Consumer Safety Officer at CDER, US FDA, and
member of FDA's Part 11 task force gave an update on Part 11 at the
annual meeting of GAMP America. The title of the presentation was:
"Current Phase of the Part 11 Proposed Amendment Process". Main
topics of the presentation have been: Problems with the original
rule, examples of systems that are now outside of the scope of Part
11, current FDA concerns and approach for computer system
validation, validation of COTS vs. internally developed systems and
FDA's current and future approach for legacy systems. Most
interesting have been examples from predicate rules that would
trigger electronic audit trails and electronic signatures. Mr. Smith
also informed the audience about the Part11 amendment process and he
gave an outlook of Part 11 and FDA's further plans. The presentation
can be downloaded
from the Labcompliance UsersClub. For preview and ordering the users
club, click
here.
July 27, 2007
Lack of Method Transfer or Revalidation Protocol Cited in an FDA
Warning Letter
The FDA expects analytical methods that are transferred between
laboratories to follow a pre-approved transfer protocol. This became
obvious in an FDA warning letter. The warning letter stated:
"Methods that were validated at one facility and transferred to xxx
site are being used without method transfer or revalidation
protocol". The FDA also noted that there was no establish
scientifically sound and appropriate specifications, standards,
sampling plans, and test procedure designed to assure products
conform to appropriate standards of identity, strength, quality, and
purity. FDA's expectations for methods transfer and various options
for compliance have been discussed in recent Labcompliance
audio
seminar that has been recorded and is available with all
reference material. The warning letter can be downloaded from the
Labcompliance Usersclub.
Non members can
preview excerpts.
July 27, 2007
FDA GMP Update
Frederick W. Blumenschein, Chief of FDA's Case Management and
Guidance Branch, CDER gave an FDA GMP update at the 2nd European GMP
Conference. The conference took place in Heidelberg, Germany, and
was organized by the European Compliance Academy (ECA) and the
University of Heidelberg. The title of the presentation was:
Overview of the U.S. FDA Pharmaceutical Quality Regulatory System
and Recent Surveillance, Guidance, Enforcement Activities. At the
beginning Mr. Blumenschein had a lot of information on FDA's
organization, on responsibilities of FDA's centers and also about
FDA's inspection program. In the second part the audience was told
that that the FDA will use a phased approach to modernize and
harmonize GMPs. The first phase is expected to be effective at the
end of this summer. Mr. Blumenschein talked about eight changes but
most likely there will be more. FDA is also working on a new guide
for process validation. The draft is expected to released at the end
of this year. The guide will recommend a lifecycle approach to
production and process control with four phases: design, confirm,
assess and monitor. The presentation can be
downloaded
from the Labcompliance UsersClub. For preview and ordering the users
club,
click here.
July 27, 2007
New Review Article on Computer Validation
Led by Rory Budihandojo a team of computer validation experts
authored a review article entitled: A Perspective on Computer
Validation. The article provides a historical review of computer
validation in the pharmaceutical industry within the last three
decades, evolving from the early years' initial concept and approach
to today's current practices. Also included is how the regulations
and industry have progressed in addressing the topic of computer
validation. Authors included Steve Coates, Ludwig Huber, Jose E.
Matos, Siegfried Schmitt, David Stokes, Graham Tinsley and Maribel
Rios. The article has been published by
Pharmtech and as of July 2007 is available on the publishers
website. Copyright rests with the publisher. For other articles from
Pharmtech, click here.
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