Labcompliance News, December 2008
Handbook for Requesting Special Information and
Records from FDA
FDA makes certain documents such as press releases, consumer
publications, speeches, and congressional testimony available on
www.fda.gov. In
addition many other documents not published on the FDA website are
available through the Freedom of Information Act (FOIA). Now the FDA
has published a handbook for requesting such information and records
from FDA. The guidance given in this handbook is intended to
facilitate requests for both public information and records not
originally prepared for distribution by FDA. Examples are
Establishment Inspection Report and 483 form inspectional
observations. The handbook has been published on the
FDA
website.
FDA Publishes New Guidance on Genotoxic and
Carcinogenic Impurities
On Dec 15, 2008, the Food and Drug Administration (FDA) has
published a new draft guidance for industry entitled "Genotoxic and
Carcinogenic Impurities in Drug Substances and Products: Recommended
Approaches." This guidance provides recommendations on how to
evaluate the safety of these impurities during clinical development
(investigational new drug applications (INDs)) and for marketing
applications (new drug applications (NDAs), biologics license
applications (BLAs), and abbreviated new drug applications (ANDAs)).
The guidance provides recommended exposure thresholds on the
clinical exposure to genotoxic or carcinogenic impurities. Also
provided are additional testing and exposure threshold
recommendations for situations where there are known or theoretical
safety concerns based on available data, structural alerts, and/or
assessment of the synthetic pathway.
More Regulatory Agencies to Join PIC/S
A joint Committee meeting of the Pharmaceutical Inspection
Convention (PIC) and the
Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) took
place in Geneva
(Switzerland) on 11-12 November 2008. Currently the organization has
34 members with more in the application process. Meeting delegates
have been informed about the status of new membership applications.
For example, Slovenia has just applied for membership, The US Food
and Drug Administration (US FDA) is more close to become a member.
The application was made two years ago and the on-site assessment
visit will take place in January 2009.
FDA Warning Letter Issued for not Validating a Planning System
Computer systems used for regulated activities should be validated. This became
obvious when the FDA inspected a system that was was used for managing inventory,
distribution of inventory, scheduling, engineering change orders, recalls,
complaints, reworks, device master records, product return, procurement,
production and sales processes. The FDA inspector wrote: "No software validation
or verification was available for the planning system. You provided some
documented “scenarios”; however there was no protocol or summary included with
those scenarios and no evidence that the tasks listed in the scenarios were ever
performed". The company also failed to perform bioburden determination, to
implement sampling plans and to train QA employees. The warning letter can be
downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts (scroll down to 211).
Top Five FDA Citations related to Biological
Drugs, Intermediates and Substances
Mary Malarkey, Director, FDA Office of Compliance and Biologics
Quality gave a compliance update at the joint PDA/FDA meeting on
September. She talked about CBER priorities, internal and
external quality systems, CBER review of submitted risk assessments,
and about the status of the amendments to CGMP regulations for
finished drugs. Most interesting was a hit list of top five
citations in FDA Warning Letters and 483's resulting from
inspections of biological drugs, biological drug intermediates and
substances. Incomplete failure investigations, inadequate
quality control, not following procedures, and no or inadequate
production and process controls. The presentation can be downloaded
from the
Labcompliance Usersclub,. For preview and ordering,
click here, scroll down to G-277
50 New Documents in the Labcompliance Usersclub
We have added 50 new documents to the Labcompliance Usersclub.
They include 11 new SOPs, 11 checklists/ templates/examples, FDA
presentations and guidance documents and FDA warning letters/483's
related to GMP/GLP or GCP. 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 400 documents ready for download.
"Investigations and CAPA Records not Maintained" Draws FDA Warning
Letter
No or incomplete failure investigations and corrective and
preventive action plans are amongst the most frequently found
deviations in FDA and other regulatory inspections. This became
obvious during an inspection of a a device distributor. Examples for
deviations include: "Failure to maintain a record of an
investigation of a complaint by a formally designated unit that
includes any corrective action taken", "Failure to establish and
maintain procedures for acceptance of incoming product, and to
inspect, test, or otherwise verify incoming product as conforming to
specified requirements". and " Failure to establish and maintain
procedures for implementing corrective and preventive action that
include requirements for analyzing processes, work operations,
concessions, quality audit reports, quality records, service records,
complaints, returned product, and other sources of quality data to
identify existing and potential causes of nonconforming product, or
other quality problem", The warning letter can be downloaded
from the
Labcompliance Usersclub. Non members can
preview excerpts (scroll down to 210). To learn everything
about FDA compliant electronic records,
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:
Scanning of Paper Records for GxP Compliant Archiving . To download
your free copy, go to the
21 CFR Part 11 Tutorial, scroll down and click on the
corresponding ICON on the left (offer expires on Jan 1, 2009).
Labcompliance offers more than 100 SOPs. For titles and ordering,
click
here.
2 Day Interactive Workshop by Dr. Ludwig Huber
-
ECHO Consulting Group
Computer System Validation and Part 11 Compliance for (Bio)Pharmaceutical
and Device Industry
Jan. 20/21, 2009 San Juan, PR, USA
Learning through examples: 50% of the time will be dedicated to
case studies
New Audio Seminars - Updated Schedule
-
Master Planning for Software and Computer Validation
With examples for master and several project plans
January 15, 2009
-
Requirement Management for Equipment and Computer
Systems
Strategies for Development, Documentation and Updating
Requirement Specifications
February 4, 2009
-
Validation and Use of Excel® Spreadsheets in Regulated
Environments
Comply with GxPs, Part11, HIPAA, SOX and other regulations.
February 11, 2009
Conferences
-
Conference
Calendar Echo Consulting
New or Updated Sites