Labcompliance News, June 2010
EU Guidance on Classification of Medical Devices
Updated
This document is a revision of an earlier document published in July
2001 as MEDDEV 2.4/1 rev 8. It includes information pertaining to
the changes in classification resulting from the amending and
implementing Directives issued since the last revision of this
document in 2001. The guidance takes a 'risk' approach for
classification based on the vulnerability of the human body taking
account of the potential risks associated with the devices. This
approach allows the use of a set of criteria that can be combined in
various ways in order to determine classification, e.g. duration of
contact with the body, degree of invasiveness and local vs. systemic
effect. These criteria can then be applied to a vast range of
different medical devices and technologies. To download the
guidance,
click here.
New Spreadsheet Quality Package
Available as Download
The popular Macro & Spreadsheet Quality Package
is now available as download version, in addition to traditional
CD/Binder Version. The content has also been updated with new SOPs
and 10 Excel validation examples documents. The package includes 13
SOPs, master and project plans, 15 examples/forms/templates. It also
includes a new audio seminar with FDA's Dennis Cantellops and Dr.
Ludwig Huber. The package helps to develop strategies
for validating and using Excel in FDA and other regulated
environments and it has the tools for trouble free implementation.
For details on content and ordering,
click here.
Genzyme Corp. Signs Consent
Decree to Correct Manufacturing Quality Violations
Genzyme Corp. has signed a consent decree
agreeing to correct manufacturing quality violations at its Allston,
Mass., manufacturing facility and will turn over to the federal
government $175 million in unlawful profits from the sale of
products that were made at the plant, the U.S. Food and Drug
Administration announced in a on May 24. During an inspection of the
Allston plant FDA inspectors found that the company's systems for
ensuring manufacturing quality were inadequate resulting in
production delays, critical shortages of medically necessary
products to consumers and drugs contaminated with metal, fiber,
rubber and glass particles. These manufacturing problems violated
the FDA’s regulations for manufacturing practice. Under the consent
decree the company agreed to adhere to a strict timetable to bring
the plant in line with the regulatory requirements of the FDA.. To
see the full article,
click here.
PIC/S Assessment of FDA Membership Targeted for the
Next Comittee Meeting
The PIC/S Committee met in Geneva (Switzerland) on 19-20 May 2010.
Following discussions with an FDA delegation, composed of
representatives of CDER and ORA1, the Committee has agreed to make a
follow-up visit to the USA in August 2010 in order to review the
outstanding issues. The assessment team will come up with a
recommendation regarding FDA’s accession to PIC/S in time for the
next Committee meeting. To see the full meeting report,
click here.
Software Testing Raw Data
not Saved Cited in FDA Warning Letter
The company has tested software and entered
the test results into a computer system. The letter reads:
"Verification and Validation report for software version 2.0 is not
available for review. According to your employee, once the results
are
entered into your electronic report, the raw tests data are
discarded. Therefore, you have no evidence the sequence testing was
performed." This warning letter is an other example for FDA's focus
on software validation and associated records. Other violations
included 'incomplete test data', 'compliant handling procedures not
implemented', 'servicing procedures not implemented', and
'inadequate training of personnel' The Warning Letter can be
downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to
W-236. Learn all about FDA inspections and recent warning
letters related to computer system and Part 11 compliance in the
Labcompliance
audio seminar.
New Template for API Quality
Agreements
The template has been developed by the Bulk
Pharmaceuticals Task Force BPTF), an affiliate of the Society of
Chemical Manufacturers and Affiliates (SOCMA). The template provides
guidance for drafting agreements relating to the manufacture and
release of FDA regulated drug substances. For more information read
SOCMA's
press release. To download the 19 page template,
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: Data Back-up and Restore. To download your free
copy, go to the
Spreadsheet Compliance website. Scroll down and click on
the corresponding ICON on the left (offer expires on June 30, 2010).
Labcompliance offers more than 120 SOPs that help to comply with FDA
and ISO 17025 compliance. For titles and ordering, click
here.
Audio Seminar Schedule
-
Analytical Instrument Qualification According to USP <1058>
With SOPs, Templates and Examples for Easy Implementation
July 8, 2010
-
Recent Warning Letters and 483's Related to Computer Validation
and Part 11
With Case Studies to Avoid and Respond to 483's and Warning
Letters
July 22, 2010
2-Day Workshop
New or Updated Sites