Labcompliance News, December 2005
December 28, 2005
Labcompliance in 2005
2005 was an other great year for Labcompliance and
website visitors: new products, new services, and significantly
increasing number of visitors were just a few highlights. We
delivered 19 Audio seminars with far over 1000 attendees, we
launched three new compliance packages Part 11, Internet/Intranet
and Computer System Validation. We also updated the Network Quality
Package. The Labcompliance Usersclub now includes more than 300
documents for instant downloads and the Newsletter with the free
Document of the Month enjoys more than 10,000 subscribers. We are
looking forward to 2006 with more new products. The first one will
be the Laboratory Compliance Package with more than 30 SOPs for
Analytical Laboratories. It will be announced in the January
newsletter. We thank our customers and other visitors of our website
for continual support.
December 28, 2005
'Missing Computer System Audits' and 'No Review of Computer
Audit Trail Cited in FDA 483
FDA regulators inspected a generic pharmaceutical
manufacturer between May 2nd and July 1st, 2005, and found practices
that did not conform with U.S. requirements. Deviations have been
documented in a 12 item inspectional observation (483). According to
the report the company failed to review computer audit trails and to
conduct audits of the of the data acquisition system used to run the
HPLC instruments during analysis of drugs. Furthermore, the FDA
noticed that laboratory records did not include complete data from
all tests, examinations and assay necessary to assure compliance
with established specifications and standards, e.g., OOS data,
chromatograms, and sample weighs. The report further stated that
manufacturing investigations into rejected batches of drugs did not
include an evaluation of the validated manufacturing process. The
483 form inspectional observation can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. To
learn more about electronic audit trails,
click here.
December 28, 2005
Recent CGMP Presentations by FDA Professional
Nicholas Bugay, FDA's Deputy Director of CDER's
Division of Manufacturing & Products Quality Office of Compliance
gave an interesting presentation on cGMP at FDA's cGMP China
training. The training was part of FDA's China training program and
was organized at the Ying Jie Convention Center Beijing of the
University Beijing on Dec 5-7, 2005. The presentation is entitled
"CGMP in the USA" and gives a very good overview on basics of GMP.
Mr. Buhay covered topics like: Overview of CGMP Requirements, Legal
bases for CGMP, CGMP legal principles, CGMP implementation tools,
CGMP resources and integrity of records and data.
December 28, 2005
European Guidelines for Electronic Records
There is no direct equivalent for 21 CFR Part 11
in Europe. Requirements for electronic record compliance can be
found in Annex 11 of the EU GMP, in the APV interpretation guide and
in the PIC/S good practices guide on using computers in GxP
environments. Annex 11 includes 19 paragraphs with requirements for
personnel, validation during development and use, audit trail,
built-in checks for correct entry of data, authorized and limited
access to the system, verification of manual data entry, automated
identification and recording of operators, procedures for change
control, back-up and protection of data, contingency planning,
disaster recovery, automated detection of errors, qualification of
3rd party service providers and release of batches by a 'Qualified
Person'. Most detailed information can be found in the good
practices guide from the pharmaceutical inspection convention scheme
(PIC/S). The document has been written by inspectors as guideline
for inspections. It also includes a six page inspection checklist
and is quite useful for the industry in preparation for internal and
external audits/inspections.
December 28, 2005
FDA Human Drug CGMP Notes
The Human Drug CGMP Notes is no longer being
published. It was published from 1993-2003 as a periodic memo for
FDA personnel intended to enhance field and headquarters
communications on CGMP issues in a timely manner. The Notes was
issued by the Division of Manufacturing and Product Quality, Office
of Compliance, Center for Drug Evaluation and Research, U.S. FDA.
Editions published during 2001 to 2003 were distributed internally
and only made publicly available by a Freedom of Information Act
request. In the meantime FDA has created the web site Questions and
Answers on Current Good Manufacturing Practices (cGMP) for Drugs for
posting answers to questions about the CGMP regulations, statute,
and related guidance. The format for these "Questions and Answers"
is similar to the Notes and now includes participation by the other
drug product centers in FDA, the Center for Veterinary Medicine and
the Center for Biologics Evaluation and Research. Each answer is
approved for posting in accordance with the good guidance practices
regulations at 21 CFR 10.115