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Online Audio Seminars come with 10+ Best Practice guides for easy implementation

 

Learning from Recent Warning Letters Related to Good Laboratory Practices

For Preparation of FDA and International GLP Inspections

Recorded, available on demand

 

Understanding and Implementing the New EU Annex 11

Learn about specific requirements and get tools for implementation

Recorded, available on demand

 

How to Prepare Yourself for FDA's New Part 11 Inspection Program

Learn what the FDA is looking for and how to respond

Recorded

 

FDA Compliant Use of (Certified) Reference Material

With 10+ Best Practices for easy Implementation

Recorded

 

Effective HPLC Method Development and Validation

Preparation, conduct and documentation for FDA/EMA Compliance

Recorded

 

Validation of Excel® Spreadsheets for Regulated Environments: Step-by-Step

With Case Studies and Validation Protocols for Easy Implementation.

Recorded

 

Understanding and Preparing for FDA's New Part 11 Inspection Program

With 10+ Best Practice Guides for Easy Implementations

Recorded

 

Recent Warning Letters and 483's Related to Computer Validation and Part 11

With Case Studies to Avoid and Respond to 483's and Warning Letters

Recorded

 

Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

Recorded

 

New  release in
2010 

with 10+ validation  examples, seminar with FDA's Dennis Cantellops and Ludwig Huber and with 13 SOPs for easy implementation.

 

 

Labcompliance News, January 2011

New EU GMP Annex 11 on Computerized Systems Released

On Jan 3, 2011, EU has released a new final version of Annex 11. Together with the updated EU GMP Chapter 4 on documentation it is the EU equivalent to FDA's Part 11. Compared to the older version l it has more detailed some very specific requirements. It addresses the regulatory needs of modern IT equipment and when implemented right, also has business benefits through reduced failure rates. The document is a good framework for validation and using computer systems and handling electronic records in different regulated environments. On the other hand it leaves a lot of room for interpretation that raises lots of questions. Attend the new Labcompliance audio seminar to learn everything about the new Annex 11 and receive 10+ best practice for easy implementation.

FDA Published Advance Notice of Rulemaking for GLP Revisions

FDA’s GLP regulations, part 58 (21 CFR part 58), were finalized on December 22, 1978 (43 FR 60013). This regulation prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by FDA, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. The conduct of nonclinical laboratory studies has changed markedly since issuance of this regulation in 1978, for example, laboratories have expanded the use of electronic technology, both for laboratory instrumentation and as a means for collecting, storing, and reporting study data. Current part 58 does not specifically describe these modern arrangements and advances. Therefore the FDA considers revising Part 58, and also applies FDA's current interpretation for inspections. Revising a regulation can be a long process and take several years. In the meantime inspections are going on. To learn everything about current FDA GLP inspection practices and inspection findings, attend the audio seminar  "Learning from Recent Warning Letters Related to Good Laboratory Practices".

"Stability Testing Co-eluting Peaks not Identified", cited in FDA Warning Letter

For the analysis of stability test samples validated stability indicating methods should be used that are appropriate determining and monitoring impurity profiles. Unexplained discrepancies, for example, non-identified co-eluting compounds should be investigated. This was stated in an FDA Warning Letter to an API manufacturer. The letter reads: "The stability assay test chromatograms for Tiger Balm, lot (3 and 6 months stability at temperature of 30°C), contained co-eluting peaks. These tests and results were approved without investigation by your quality control unit. Specifically, during the HPLC analysis, the capsaicin peak (peak of interest) was observed co-eluting with an unknown peak, while a second large unknown peak was also present in front of the capsaicin peak. In your response to this letter, provide the updated validation reports of both assay methods, including the specificity studies performed to demonstrate that both assay methods are stability indicating and appropriate for determining and monitoring impurity profiles". Other deviations included: Sampling not representative, supplier test results not verified, incomplete laboratory records, lab notebooks not controlled and reviewed, stability samples not properly controlled, stored and maintained. The Warning Letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-245.  To learn everything about FDA compliant development, validation and use of stability test methods, attend the audio seminar  "Development and Validation of Stability Indicating Methods".

USP Pharmacopeial Forum (PF)  now for Free

PF is the bimonthly online journal through which USP develops and revises standards for the United States Pharmacopeia and the National Formulary (USP–NF) by a process of public review and comment. Changes and additions to USP–NF standards are first proposed in PF to invite public comment..To encourage and broaden participation in the standards-setting process, USP transitioned PF from a subscription-based print and online publication to a free, online-only resource with the release of PF 37 (1) on January 3, 2011. To sign up, click here.

Number of GLP Warning Letters and Number of Deviations Increasing

The number of FDA warning letters following GLP study inspections is increasing. An example is a recent warning  letter following an inspection that was part of FDA’s Bioresearch Monitoring Program to verify compliance with 21 CFR 58. The warning letter lists 9 deviations. Examples include:  Personal did not understand the functions they are to perform, reports not signed by individuals, articles not tested for stability, no SOP for sterile preparation of dosing solutions, study director failed to follow applicable GLP regulations, inadequate validation of bioanalytical methods, QA failed to maintain a master schedule, SOPs not followed without justification, equipment not adequately cleaned, inspected and maintained, inadequate corrections of final reports. The warning letter has detailed examples for all deviations. The Warning Letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-244. To learn everything about FDA GLP inspections and inspection findings, attend the audio seminar  "Learning from Recent Warning Letters Related to Good Laboratory Practices".

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 "Validation of Software and computer systems for ISO 17025". To download your free copy, go to the ISO/IEC Accreditation Package website. Scroll down and click on the corresponding ICON on the left (offer expires on Feb 15, 2011). 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

  1. Learning from Recent Warning Letters Related to Good Laboratory Practices
    For Preparation of FDA and International GLP Inspections
    Recorded, available on demand
  2. Understanding and Implementing the New EU Annex 11
    Learn about specific requirements and get tools for implementation
    Recorded, available on demand

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Recent Warning Letters and 483's Related to Computer Validation and
Part 11
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