Labcompliance News, April 2008
EU Commission Publishes New Part 11 Equivalent
Annex 11 for Consultation.
The first version as published already 15 years ago has been
updated in response to increased use of computerized systems and the
increased complexity of these systems. The annex applies to all
forms of computerization in connection with regulated activities,
including process control, documentation and data-processing systems.
Compared to the previous version the new annex is more detailed. It
has chapters on Risk Management, personnel, validation, system (inventory),
software, data, user testing, security, accuracy checks, audit
trails, electronic signatures, change control, printouts, data
storage, back-up, business continuity, incident and supplier
management and on batch release. Despite of more details there is
still room for interpretations. Labcompliance will conduct an
audio seminar for better understanding and implementation.
Attendees will learn all about new requirements and get tools for
easy implementation.
FDA Releases Information on Risk Evaluation and
Mitigation Strategies (REMS).
A Risk Evaluation and Mitigation Strategy (REMS)
is a strategy to manage a known or potential serious risk associated
with a drug or biological product. A REMS will be required if FDA
finds that a REMS is necessary to ensure that the benefits of the
drug or biological product outweigh the risks of the product, and
FDA notifies the sponsor. A REMS can include a Medication Guide,
Patient Package Insert, a communication plan, elements to assure
safe use, and an implementation system, and must include a timetable
for assessment of the REMS. Some drug and biological products that
previously were approved/licensed with risk minimization action
plans (RiskMAPs) will now be deemed to have REMS.
New FDA Guidance for Industry: Coronary
Drug-Eluting Stents-Nonclinical and Clinical Studies
This guidance is intended to provide recommendations to sponsors
or applicants2 planning todevelop, or to submit to FDA, a marketing
application for a coronary drug eluting stent (DES). The guidance
discusses the data and clinical studies needed to support such an
application. This guidance does not discuss noncoronary DESs (e.g.,
peripheral drug-eluting, nonvascular biliary stents) or stents that
contain biological product components such as cell or gene therapy
or therapeutic biological products such as monoclonal antibodies.
The guidance makes recommendations for stents made from metallic
stent substrates, but does not provide complete information for
degradable stents or stents made from other material substrates
(e.g., polymer or ceramics).,
FDA Warnings for Part 1 1 Deviations but Part 11 not
Mentioned
The long expected new revision of Part 11 has not yet been
released but FDA continues to enforce Part 11 requirements. Examples
from a quality control are quoted in a recent warning letter:
unauthorized changes of setpoints, no user access levels to the
system and data, use of common passwords, no validation for security
functions and the system does not have an audit trail to document
changes, The company suggested corrective actions for some failures,
the FDA's response was: Please explain why this correction cannot be
completed in a more timely fashion. The warning letter can be
downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts (scroll down to 198).
FDA Guidance: Container and Closure System
Integrity Testing in Lieu of Sterility Testing as a Component of the
Stability Protocol for Sterile Products
This guidance document provides recommendations to manufacturers,
for using methods other than sterility testing to confirm container
and closure system integrity as a part of the stability protocol for
sterile biological products, human and animal drugs, and medical
devices. This guidance document finalizes the draft guidance of the
same title dated January 1998 (January 28, 1998, 63 Federal Register
(FR) 4272).t
The recommendations in the guidance document apply to both pre-
and post-approval stability protocols for sterile biological
products, human and animal drugs, including investigational and bulk
drugs. For medical devices, the recommendations in the guidance
document apply to stability protocols for those devices labeled as
sterile.
FDA Withdraws Part 211 Update
On December 04, 2007, the FDA has published the text of an
updated version of the drug cGMP regulation, 21 CFR 211. At the same
time the FDA announced that the text is final as the agency did not
expect critical adverse comments. Obviously there were enough
such comments with the consequence that on April 4 the FDA did
withdraw the direct final rule. The FDA will consider the comments
received under the usual procedures for notice and comment in
connection with the notice of proposed rulemaking that was published
in the Federal Register of December 4, 2007, as a companion to the
direct final rule (72 FR 68113).
New Revision of EU GMP Annex 13 Available for
Public Consultation
Annex 13 deals with manufacturing investigational new products. The
application of GMP to the manufacture of investigational medicinal products is
intended to ensure that trial subjects are not placed at risk, and that the
results of clinical trials are unaffected by inadequate safety, quality or
efficacy arising from unsatisfactory manufactured. Based on practical
experiences a revision of the Annex was deemed necessary to clarify certain
points related to reference and retention samples, the two-step release
procedure for investigational medicinal products and to the principle of
independence between production and quality control functions.. The draft Annex
can be downloaded from the EUDRALEX website.
Warning Letter: Software for Trend Analysis not Validated
The FDA expects software used for trend analysis and complaint
handling to be validated . This became obvious from a warning letter
with a statement the validation of the software used to perform the
trend analysis has not been provided to support your firm's claim
that the software can be used effectively to prevent the firm from
overlooking complaints.. Moreover the company failed to document the
justification for use of the nonconforming product and the signature
of the individual(s) authorizing the use The warning letter
can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts (scroll down to 197).
Part 11 Package now With Video Seminar
The Part 11 Compliance package now comes with the Video Seminar.
"How to Prepare Your Organization for the 'New' Part 11", - Learn
What's Coming and How to Implement - This seminar together with all
SOPs available in the package will make sure your company complies
with the new scope of Part 11 - at reasonable costs.
New Audio Seminars - Updated Schedule
-
Understanding and Implementing the New EU Annex 11
Learn about specific requirements and get tools for
implementation
May 8, 2008
-
Sampling and Sample Handling in Laboratories (195)
Strategies for FDA and ISO 17025 Compliance and Tools for
Implementation
May 20, 2008
-
Development and Validation of Stability Indicating Methods (196)
Planning - Design - Conduct - Documentation
May 29, 2008
-
Contingency and Disaster Recovery Planning for Computer Systems
(197)
To Ensure Business Continuity and Compliance
June 12, 2008
-
Writing Effective SOPs For Regulatory Compliance
Content, format, approval, training and distribution.
Thursday, June 26, 2008
New or Updated Sites