Source: http://labcompliance.com/news/2008/04_april_news.aspx
Timestamp: 2020-01-23 14:04:20
Document Index: 526098212

Matched Legal Cases: ['art 11', 'art 1', 'art 11', 'art 11', 'art 11', 'art 211', 'art 11', 'art 11', 'art 11', 'art 11']

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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).
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).
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.