Labcompliance News, February 2009
FDA
Introduces Globalization Act of 2009
On April 17, 2008, a discussion draft for an
"FDA Globalization Act of 2008" has been released, and a
revised version of the draft has been published in July. The
Discussion Draft was meant to stimulate discussion about how to
provide adequate funding and authority for FDA to ensure the safety
of the Nation's food, drug, medical device and cosmetic supply in an
increasingly globalized marketplace. For details
see Labcompliance News from
June 2008. Now the act has been officially introduced by
Congressman John D. Dingell (D-MI) as the
FDA Globalization Act of 2009 and bill
HR-759. Currently, the bill is in the The House Committee on Energy
and Commerce for review. After approval it will go to the
House for voting. Then the Senate will vote and after that it is
forwarded to the president and is signed into law. The bill is
available on the internet as PDF for
download. For pharmaceutical, API and device manufacturers the
act means: New fees, more inspections, more documentation, To get a
good understanding on all details
click here
FDA's Spreadsheet Expert
Answers Questions on Excel Validation
On February 12 Dennis Cantellops joined the
Labcompliance audio seminar: Using Excel in Regulated Laboratories.
Dennis is QA manager at the FDA Laboratory San Juan, and main author
of FDA's two Information Bulletins on Design and Validation of
Spreadsheets. Dennis explained FDA's approach on how to design,
develop, validate and use Excel spreadsheets in FDA regulated
environments. He also answered the many questions from the
audience. Most frequently asked questions were about the type and
extend of testing, how to make out-of-the box Excel Part 11
compliant, when do we need electronic audit trail, and what type of
data should be reviewed in routine use. To learn about FDA's
approach and to get answers to the questions, download the recorded
Audioseminar.
Revision of the
PIC/S GMP Guide
The PIC/S GMP Guide (PE 009-8) has been revised in parallel with
the EU GMP Guide.
The following changes were made:
- Chapter 1 (Part I) has been
revised in order to include aspects of quality risk management
within the quality system framework.
- Annex 1 has been revised in
order to align the classification table for environmental
cleanliness of clean rooms with ISO standards and to provide
supplementary guidance on the application of the principles and
guidelines of GMP to sterile medicinal products,
- A new Annex 20 has been adopted
in order to implement the ICH Q9 guideline on Quality Risk
Management. This Annex is voluntary
The revised PIC/S GMP Guide will enter into
force on March 1, 2009. It is now available for downloaded from the
PIC/S
website
.
FDA Guidance: Standardized Numerical
Identification for Prescription Drugs
On Jan 22 the FDA released the Industry
Guidance: Standards for Securing the Drug Supply Chain -
Standardized Numerical Identification for Prescription Drug Packages.
The guidance is intended to address provisions set forth in Section
505D of the Federal Food, Drug, and Cosmetic Act (the act) regarding
development of standardized numerical identifiers (SNIs) for
prescription drug packages. In this guidance, FDA is identifying
package-level SNIs, as an initial step to facilitating other
measures for securing the drug supply chain.
FDA CDER Plans for New
Guidances in 2009
The US Food and Drug Administration (FDA) has
published a list of guidances CDER is planning to develop during
calendar year 2009. Amongst them are guidances for "Contract
Manufacturing", "21 CFR Part 11", "Pharmaceutical Component Quality
Control" and "Content and Format of the Clinical Pharmacology
Section".
New FDA Guidance Refers to
ISO/IEC 17025 for Laboratory Testing
For the first time the FDA refers to ISO 17025
in an industry guidance. The new guidance comes into effect when the
FDA denies regulated products (biological products, food, drugs,
devices) from import into the United States. In this case the
importer has to provide full laboratory packages to demonstrate
compliance. In addition most likely the product will be tested in
FDA laboratories. Importers now have the option to provide
abbreviated laboratory packages if testing was performed in an
accredited laboratory, Advantage for the FDA are: less resources are
required for extensive review of the full package and for laboratory
testing. Main advantage for the importer is faster import approval.
According to the guidance accreditation should be assessed in
conformance with ISO/IEC 17025 as "The most widely used
laboratory standard for federal testing laboratories, including
FDA’s own laboratories". The guidance can be downloaded from the
FDA
website. In our opinion this is just the first step to leverage
ISO 17025. For example,
FDA's new Globalization Act requires all imported products
either to be entered into United States through a port of entry that
is located in a metropolitan area with federal testing laboratory or
to provide documentation demonstrating compliance with
identity/purity requirements 'certified by an accredited third
party'. The last step may be that the FDA offers the option for all
product testing as required by GLP, GCP and cGMP: reduce FDA review
time and FDA testing through demonstrating conformance with ISO
17025. Labcompliance is well prepared for this move. We have a
lot of tools to get a good understanding and for
implementing ISO 17025. Examples are
- A free
Tutorial
- Audio seminar:
Effective Gap Analysis for ISO 17025
- Audio seminar:
Understanding and Implementing ISO 17025
-
ISO 17025 Accreditation Package with
an example quality plan and 30+ procedures
- One day workshop, for example, on March 20 2009 in
Hanoi, Vietnam
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 Checklist: ISO 17025 Accreditation . To download
your free copy, go to the
ISO 17025 Tutorial, scroll down and click on the corresponding
ICON on the left (offer expires on Mar 15, 2009). Labcompliance
offers more than 100 Examples that help to complyy with FDA and ISO
17025 compliance. 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: $50,
The seminar includes the download version of the Laboratory
Compliance Package from Labcompliance (regular price: US$ 579)
New Audio Seminars - Updated Schedule
-
Measurement Uncertainty in Chemical Analysis
With tools to comply with ISO17025 Standard and FDA expectations
March 5, 2009
-
Management and Validation of Computers for ISO 17025
Requirements, Recommendations and Tools for Implementation
April 8, 2009
-
IT Infrastructure and Network Qualification
Introduction and Strategies for Compliance and System Uptime
April 23, 2009
-
Traceability in Chemical Analysis
With strategies and tools for ISO 17025 and FDA Compliance
April 30, 2009
-
Effective Verification of Compendial Methods
Understanding USP and FDA Requirements and get Tools for
Implementation
May 14, 2009
-
Auditing Laboratories for FDA and ISO 17025 Compliance
Preparation - conduct - follow up - documentation
June 18, 2009
-
Managing Out of Trend Results in Pharmaceutical
Manufacturing and Quality Control
Comply with the FDA and international guidances
July 9, 2009
New or Updated Sites