Labcompliance News, December 2009
FDA Releases New Revision of ICH
Guidance Q8
The US Food and Drug Administration just
released a new revision of ICH Q8 'Pharmaceutical Development' that
was published in May 2006. In June 2009, the Q8 parent ICH guidance
was revised to add an annex, which provides further clarification of
the key concepts outlined in the May 2006 guidance and describes the
principles of quality by design (QbD). The Guidance can be
downloaded from the
FDA
website
50 New Documents in
the Labcompliance Usersclub
We have added 50 new documents to the Labcompliance Usersclub.
They include 12 new SOPs, 11 checklists/ templates/examples, FDA
presentations and guidance documents and FDA warning letters/483's
related to GMP/GLP or GCP. There is a video clip with an update on
Part 11. To see the new titles,
click here. User club
members can instantly
download the new additions. To see the list and ordering the
users club,
click
here, and scroll down to 'new additions'. With these additions,
the Usersclub has more than 500 documents ready for download.
The First 'Closeout Letter' Posted on the FDA
Website
In August FDA commissioner Margaret A. Hamburg, M.D, had
announced the development and implementation of a formal warning
letter “close-out” process. With this the agency determines that a
firm has fully corrected violations raised in a warning letter and
post this information on the FDA Web site. Now the FDA has posted
the first
letter. The letter states: "The Food and Drug Administration has
completed an evaluation of your firm's corrective actions in
response to our Warning Letter dated October 08, 2009. Based on our
evaluation, it appears that you have addressed the violation(s)
contained in this Warning Letter. Future FDA inspections and
regulatory activities will further assess the adequacy and
sustainability of these corrections"
Increasing FDA Focus on
Computer Validation
While FDA was quiet about software and computer system
validation between 2002 and 2006 this has changed significantly since 2006.
Software and computer system validation has become an inspection focus for
pharmaceutical, API and device industry. Deviations have been cited related
to all steps of computer validation from writing specification and risk
assessment to IQ/OQ/PQ, revalidation, reporting and change control. To see
examples,
click here. To prepare your organization for FDA inspections, and
to avoid FDA warning letters related to computer validation, attend the
upcoming
Audio
seminar: Computer System Validation: Step-by-Step, with Case Studies and
IQ, OQ, PQ protocols for easy implementation
FDA Releases Final Guidance
on Residual Solvent Analysis
The guidance replaces the draft
version from August 2008. With the new guidance FDA allows using
test data as an alternative to tests performed by the drug
manufacturers: "FDA can accept residual solvent test data on
components from tests performed by the drug product manufacturer or
the manufacturer may provide test data or, if applicable,
appropriate statements obtained from properly qualified suppliers as
described in 21 CFR 211.84(d)(2). For example, reports of analysis
can be accepted from a properly qualified supplier of a drug
product component and will be used by the drug product manufacturer
to determine whether the finished drug product complies with the
General Chapter <467> defined limits." The guidance is available on
the
FDA Website. To learn everything about residual solvents
analysis according to the new FDA Guidance and USP <467> attend the
Labcompliance audio seminar and receive updated best practice
documents for easy implementation.
FDA Warns Drug Manufacturer
for not including Dissolution in the Stability Program
A drug manufacturer was cited in an FDA Warning Letter for not
including dissolution and controlled-release drug
product specifications in the stability program. The letter
states: The written stability program for drug
products does not include reliable, meaningful and specific test
methods which include dissolution testing and the establishment of
controlled-release drug product dissolution specifications for any
of the marketed tannate drug products to ensure finished drug
product performance at expiry, as required by 21 CFR 211.166(a)(3).
In addition the company failed detect all active ingredients in the
finished product. The the warning letter can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts (scroll down to 225).
To learn everything about an FDA complaint
stability program, attend the upcoming
Audio seminar: Stability Testing for FDA and ICH compliance..
GHTF Publishes Guidance on
Corrective and Preventive Actions
The Global Harmonization Taskforce has
published a draft guidance on corrective action and preventive
action and related QMS processes. GHTF is a voluntary group of
representatives from medical device regulatory agencies and the
regulated industry. The guidance is intended for medical device
manufacturers and regulatory authorities but the concepts and
recommendations are also useful for other industries.. The 25 page
guidance can be downloaded from the
GHTF website
as word and PDF document.
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: Subcontracting of Testing and Calibration. 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 June
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
-
Computer System Validation: Step-by-Step
With Case Studies and IQ, OQ, PQ Protocols for Easy
Implementation
January 14, 2010
-
Stability Testing in Pharmaceutical and API Industry
Learn how to design, conduct and document studies for FDA and
ICH requirements
January 21, 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
New or Updated Sites