Labcompliance News, March 2010
Revised Draft of the Annex
11 to EU GMPs to be Released in the next few Weeks
In April 2008 the EU Commission Publishes has
released the EU Part 11 Equivalent Annex 11 for Consultation. The
industry was concerned about too stringent requirements. The
committee did get 1400 comments. In the next couple on weeks a new
more industry friendly version will be released. The number of pages
did go down from actual 11 to 4 which is not too far away from the
size of the original Annex 11 as published in 1993. To download the
draft from 2008,
click here.
FDA Inspection Focus on
Security, Availability and Integrity of E-Records
FDA continues to enforce 21 FFR Part 11.
Inspection focus is on data security, integrity and availability of
e-records. Observations and deviations get more and more specific.
For example a recent 483 lists observations such as 'missing back-up
of HPLC and UV data', 'insufficient procedures and technical
controls to access computers and data' and 'no protection of PC
monitor screens (inactive screen saver)'. Furthermore, the 483
reads: "Appropriate controls are not exercised over computers
or related systems to assure that changes in master production and
control records or other records are instituted only by authorized
personnel". and "No written procedures for this computer system that
outlines the responsibilities and privileges of the personnel who
utilize the software". Other observations include: "no written
procedures for production and process controls, failure
investigation not extended to other batches, suitability of testing
methods not verified under actual conditions", The 483 inspectional
observation with 24 observations can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to
W-231. Learn all about 21 CFR Part 11 requirements and how to
avoid 483's in the Labcompliance
audio seminar.
FDA Releases Guidance for
Product Sterilization Control
According to the guidance
sterility requirements can be met without conducting a formal
sterility test control of the sterilization process through
parametric release can be demonstrated.
Parametric release allows manufacturers to replace sterility testing
of samples drawn from the finished product as a release criterion
with acceptance criteria for the control of identified process
parameters. Section IV of the guidance describes what submissions
are required to obtain approval for parametric release.11 The
approval of parametric release practices is based on an assessment
of the applicant’s proposed critical process parameters and how they
are control. The guidance can be
downloaded from the FDA website.
APIC Publishes Guidelines
and Two Templates for Quality Agreements
The Active Pharmaceutical Ingredients
Committee (APIC), published a guideline and two templates for
quality agreements for manufacturer of APIs. The recommendations are
in line with regulatory expectations and are useful in preparation
for professional contracts, .
Labcompliance Usersclub gets
more Attractive with new Document Category
Members of the Labcompliance Usersclub
currently can instantly download more than 500 documents: SOPs,
checklists, validation examples, forms and FDA Warning Letters
& 483s, video clips. Now we have added a new category with master
plans, primers and step-by-step implementation guidelines for
various applications. The first addition is the FDA Inspection
Survival Guide with 60+ pages full of recommendations on how to
prepare your organization effectively for FDA ad other inspections.
Special focus is on how to respond to 483's and to avoid FDA warning
letters. The Warning letter can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to
M-222.
"Stability Chambers not
Re-qualified" Cited in Recent FDA 483
Considering that stability chambers play a
major role in a company's stability testing program, the FDA
requires stability chambers to be calibrated, qualified and
re-qualified under empty and load conditions. This became
obvious in 483 inspectional observation. : For example,
one observation states: "You do not perform requalification of
stability chambers." The FDA expects to challenge the camber under
load: "The original qualification of all chambers only included
mapping studies with empty chambers. The chambers were never
challenged by filling the storage space and proceeding with mapping
studies. These chambers were observed with to be fully loaded".
Other observations included: insufficient number of people to
perform the assigned task, annual report does not include
distribution data, no HPLC detector noise and drift
check, carry over for HPLC injector not tested, no signature of a
review person on laboratory test results. The 483 inspectional
observation with 24 deviations can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts: Scroll down to
W-231. Learn all about FDA compliance qualification and
maintenance of stability chambers in the new Labcompliance
audio seminar.
New Supply Chain Guidance
from TGA
Good Manufacturing Regulations require to
qualify and approve suppliers of critical material. Now the
Australian Therapeutic Drug Monitoring and Control Agency (TGA)
released a new guidance on supplier qualification. The document is
relevant to Non-Sterile Medicines and Complementary Medicinal
Products and provides a formal and transparent process for the steps
by which supplier qualification may be achieved. Recommended tools
include evaluation of a questionnaires and other reference material
and on-site audits.
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: Disaster Recovery for Computer Systems. To
download your free copy, go to the
Computer System Validation Package website. Scroll down
and click on the corresponding ICON on the left (offer expires on
April 5, 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
New or Updated Sites