Labcompliance News, January 2010
USP Proposes three new
Chapters for Heavy Metal Impurity Analysis
USP takes a new approach for Heavy Metal
impurities, now called Elemental Impurities. The proposals for three
new chapters and two stimuli articles are being published in the
January-February issue of Pharmacopeial
Forum (PF 36(1). Chapter <232> specifies the compounds and
limits, chapter <233> measurement procedures and chapter <2232> is
for elemental contaminations in Dietary Supplements. The stimuli
papers provide more detailed information and discuss comments and
responses from the advisory panel. For more information, visit the
USP
website.
Labcompliance has scheduled an
audio seminar. This provides a good overview with background
information, methodologies, a comparison with EU requirements and
approaches to implement the proposals.
A Vendor's Statement is not
Enough Evidence for Software Validation
Still today some vendors advertize software as
being validated, and companies erroneously believe they don't have
to validate the software at the user's site. This was clarified
during an FDA inspection of a software used in a human tissue bank.
When the investigator asked for validation documents the company
only showed her a letter from the vendor indicating that the
software was validated which was the reason why the company
purchased this product. An observation in the 483 simply stated that
the performance of computer software has not been verified. More
information on what went wrong was disclosed in the associated
Establishment Inspection Report (EIR): "The firm must verify the
performance of the computer software for the intended use and
document these activities". For a full article,
click here. The 483, the EIR and the company response can be
downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to W-226
for the 483 and to W-191 for the EIR and the company response.
Get step-by-step advice on software and computer system validation
during the Labcompliance audio seminar
Computer System validation: Step-by-Step.
New FDA Guidance on Assay
Development for Immunogenicity Testing
The Food and Drug Administration announced in
a Federal Register notice the availability of a draft guidance for
industry entitled ‘‘Assay Development for Immunogenicity Testing of
Therapeutic Proteins.’’ The draft guidance provides recommendations
to facilitate industry’s development of immune assays for assessment
of the immunogenicity of therapeutic proteins during clinical
trials. The guide can be downloaded from the
FDA website.
FDA 'Advice' on Validation and Use of 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.
Updated FDA Guidance for
Non-Clinical Safety Studies
The FDA has released a new revision of an
earlier ICH guide: "Nonclinical Safety Studies for the Conduct of
Human Clinical Trials and Marketing Authorization for
Pharmaceuticals" The purpose of the document is to recommend
international standards for, and promote harmonization of, the
nonclinical safety studies recommended to support human clinical
trials of a given scope and duration as well as marketing
authorization for pharmaceuticals. Harmonization of the guidance for
nonclinical safety studies will help to define the current
recommendations and reduce the likelihood that substantial
differences will exist among regions. This guide applies to the
situations usually encountered during the development of
pharmaceuticals and should be viewed as general guidance for drug
development. The guide can be downloaded from the
FDA website.
Not Putting Finished Drugs
on Accelerated Stability Studies Draws FDA Warning
A pharmaceutical manufacturer only had put
development batches on accelerated and long-term room temperature
stability studies to justify the assignment of a tentative
expiration dating period but not finished products. And there was no
documentation or data to support or demonstrate equivalence between
development and commercial batches with regards to equipment,
components, and manufacturing processes. The manufacturer was
recommended to provide a time frame for completion of the corrective
action plans, and a more detailed stability commitment. In addition
the FDA found other deviations: inadequate Drug production and
control records not reviewed by QCU, complaints not reviewed during
annual product review and, failures to clean, maintain and sanitize
equipment. The Warning letter can be
downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to
W-227. Learn more about FDA enforcement in the Labcompliance
audio seminar and how to plan, conduct and document stability
studies to be in line with ICH and FDA requirements.
New Audio Seminars in 2010 -
Schedule Available
The popular Labcompliance audio seminar series
will go on in 2010 with more offerings. in Q1 we offer a total of
nine seminars with new topics such as stability testing, ASTM E2500
for equipment verification, and USP's new approach for heavy metal
analysis. The list below shows all seminars to be delivered in Q1.
To see the complete list with over 100 recorded seminars,
click here, By the way, in the first seminar this year we
had one company attending with 60 employees from all departments to
learn everything about Validation of Computer Systems: Step-by-Step.
To see the content and the attendees` feedback,
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: Document Management and Control. To download
your free copy, go to the
ISO 17025 Accreditation Package website. Scroll down and
click on the corresponding ICON on the left (offer expires on
February 20, 2010). Labcompliance offers more than 100 SOPs that
help to comply with FDA and ISO 17025 compliance. For titles and
ordering, click
here.
Audio Seminar Schedule for Q1/2010
-
Validation of Analytical Methods and Procedures
Conduct and Document for Efficiency and FDA, USP/EP and ISO
17025 Compliance
February 3, 2010
-
Validation and Use of Excel® Spreadsheets in Regulated
Environments
Comply with GxPs, Part11, HIPAA, SOX and other regulations.
February 18, 2010
-
Simplify Validation and Qualification with ASTM E2500
Cost Effective Alternative for Equipment Qualification and
System Validation
February 25, 2010
-
Analysis of Metal Impurities According to New USP
Chapters
Understanding the Proposed USP Chapters <232>, <233> and <2232>
for Elemental Impurities
March 3, 2010
-
How to Efficiently Get ISO 17025 Accreditation
Step-by-step from the idea to cost-effective implementation
March 4, 2010
-
Documentation for FDA and ISO 17025 Compliance
Step-by-step Instructions with Sample Documents
March 25, 2010
-
Qualification and Calibration of Stability Chambers
Learn how to select, conduct and document the right test
parameters and conditions
March 31, 2010
New or Updated Sites