Home | Contact Us | Newsletter | Usersclub | Books | Audio Seminars

 

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.
June 26, 2008

 

FDA/EU cGMP Compliance for Laboratories
Requirements and Tools for Implementation
Wednesday, July 2, 2008

 

Out-of-Specification Data Trending
GMP requirements and tools for implementation
July 3, 2008

 

Cost Effective Software and Computer System Validation
Take Advantage of New Recommendations from FDA, EU Annex 11 and GAMP® 5
July 24, 2008

 

Understanding and Implementing the New EU Annex 11

Learn about specific requirements and get tools for implementation
Rercorded

 

Understanding the New USP <1058> for Analytical instrument Qualification

With SOPs, Templates and Examples for Easy Implementation

Recorded

 

NEW BOOK EDITION

Dr. Ludwig Huber

 

 

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

  1. Understanding and Implementing the New EU Annex 11
    Learn about specific requirements and get tools for implementation
    May 8, 2008
  2. Sampling and Sample Handling in Laboratories (195)
    Strategies for  FDA and ISO 17025 Compliance and Tools for Implementation
    May 20, 2008
  3. Development and Validation of Stability Indicating Methods (196)
    Planning - Design - Conduct - Documentation
    May 29, 2008
  4. Contingency and Disaster Recovery Planning for Computer Systems (197)
    To Ensure Business Continuity and Compliance
    June 12, 2008
  5. Writing Effective SOPs For Regulatory Compliance
    Content, format, approval, training and distribution.
    Thursday, June 26, 2008

New or Updated Sites

Click here to tell others in your company about news