Labcompliance News, June 2011
FDA Warning Letters increasing by 30% in FY 2011
According to an article published by
FDA News FDA has already issued 874 warning letters in fiscal
2011, compared with 673 last year. This is an increase of 30%.
According to an earlier
Labcompliance News article inadequate laboratory laboratory
controls have been #1 deviations in FY 2010. according to the
Labcompliance analysis of FDA GxP related warning letters, a
similar trend is expected for 2011.
Periodic Evaluation and Review of Computer Systems
Legally Required
Since quite some time periodic review of computer systems has been
suggested by industry task forces such as GAMP and regulatory
guidance such as the PIC/S Good Practices Guide for computer systems
used in regulate GxP environments. GMP. Also the FDA expects a
periodic evaluation and review to ensure that a system, once
validated, remains in a validated state. And periodic review of
computer systems becomes a legal requirement for the European market
after July 1, 2011. Chapter 11 of the new
EU GMP Annex 11 reads: Computerized systems should be
periodically evaluated to confirm they remain in a valid state and
are compliant with GMP. Attend the new Labcompliance
audio seminar to learn everything about regulatory expectations
and effective implementation of periodic evaluation and review.
FDA Expects to Validate or Verify the Accuracy of
Bioanalytical Methods
FDA GLP regulations do not specifically spell out the requirement
for validation or verification of methods used for preclinical
studies. However FDA expects that laboratories have documented
evidence that such methods are suitable for intended use. FDA and
EMA have developed guidance documents for validation of
bioanalytical methods targeted to clinical and preclinical studies.
And FDA inspectors check proper method performance during
inspections. An example is a warning letter that was issued after a
GLP study inspection. The letter reads statements such as: "FDA
found that SNBL failed to use quality control samples in
toxicokinetic assays to ensure quantitative accuracy of the
bioanalytical method" and "Study Directors failed to ensure that
bioanalytical methods used in nonclinical laboratory studies were
accurate". and "There is no assurance the Study Director records and
verifies the accuracy of bioanalytical methods used in nonclinical
safety studies.
The Warning Letter can be downloaded from the
Labcompliance Usersclub. Scroll down to W-244.
Non members can
preview excerpts. To learn everything
about validation of bioanalytical methods,
attend the
audio seminar "Validation of Bioanalytical
Methods
and Procedures".
New FDA Guidance about Enforcement of Safety
Reporting Requirements for INDs and BA/BE Studies
This document provides guidance to sponsors and investigators on
enforcement of FDA’s final rule, “Investigational New Drug Safety
Reporting Requirements for Human Drug and Biological Products and
Safety Reporting Requirements for Bioavailability and Bioequivalence
Studies in Humans” (75 FR 59935, September 29, 2010). This guidance
contains information regarding the Agency’s intent to exercise
enforcement discretion regarding the reporting requirements in the
final rule until September 28, 2011. The guidance can be downloaded
from the
FDA website
Shares fall 5 Percent Caused by an
FDA GMP Warning Letter
The warning letter
has been received after an FDA inspection in
December 2010 and January 2011. The specialty pharmaceutical company
failed to comply with requirements for sampling and testing of
in-process materials, for handling out-of-specification situations
and production record review. According to a note from a security
analysts the warning letter
does not affect the company's manufacturing
and shipment of approved products, but could cause FDA to withhold
approval of pending applications.
For the complete article,
click here. The warning letter
can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to W-252.
Part 11 Related Deviations Cited in FDA
Warning Letter
As part of the ongoing Part 11 inspection program FDA inspections
continue to focus on Part 11 requirements. This became obvious in a
recent warning letter going to a pharmaceutical manufacturer. The
company used a computer system to control setpoints and to monitor
records from equipment, room differential pressure, room humidity,
and stability chambers. The system was password protected but
all employees had access to the room where the computer system was
located. The problem was that all employees entering the room could
disconnect an external hard drive, and change data and delete data
without a password and resave on the computer system without leaving
a trace.
The Warning Letter can be downloaded from the
Labcompliance Usersclub. Scroll down to W-253.
Non members can
preview excerpts. To learn everything
about FDA's s,
on-going Part 11 inspection program
and other recent warning letters
attend the
audio seminar "How to Prepare Yourself for FDA's
on-going Part 11 Inspection Program".
FDA Publishes Names and Addresses of Inspected
Facilities
As part of
its Transparency Initiative the FDA published names and addresses of
all facilities that have been inspected in FY 2009 and 2010. The
data also include the products that the facilities produced and the
inspectional classification: No action indicated (NAI), voluntary
action indicated (VAI) or official action indicated (OAI). The data
are published as an Excel spreadsheet that can be viewed and
downloaded from the
FDA website.
Approvals for Biopharmaceuticals nearly doubled in
the past Decade
Compared with the 1990s the regulatory
approvals of biopharmaceutical medicines in the United States have
nearly doubled. FDA approved 65 new biopharmaceuticals
between 2000 and 2009, up from 39 approvals during the 1990s, and 13
in the 1980s. According to a report from the the Tufts Center for
the Study of Drug Development, there are also some challenges, for
example, the average combined clinical and approval phase time for
biopharmaceuticals rose to 95 months during the 2000s, up from 77
months in the 1990s. The full article has been published by
Biopharm. Compliance issues may be one of the reasons for the
delay. Attend the
new seminar FDA Compliance for Biopharmaceutical Laboratories to
learn everything about FDA and international requirements.
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 "Revalidation of Software
and Computer Systems". To download your free
copy, go to the
Macro and Spreadsheet Quality Package website. Scroll down and
click on the corresponding ICON on the left (offer expires on
July 1 , 2011).
Labcompliance offers more than 130 SOPs
that help to comply with FDA and ISO 17025 compliance. For titles
and ordering, click
here.
Audio Seminar Schedule
-
Validation of Bioanalytical Methods and Procedures
Conduct and Document for Efficiency and FDA&EMA Compliance
Recorded
-
How to Prepare Yourself for FDA's on-going Part 11
Inspection Program
Learn what the FDA is looking for and how to respond
Recorded
-
Periodic Review and Evaluation of Computer Systems
With strategies and tools for FDA and EU compliance
July 28, 2011
-
Understanding the New USP Chapters 232/233 for Metal
Impurities
With SOPs and Case Studies for Easy Implementation
August 11, 2011
New or Updated Sites