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

Learn what the FDA is looking for and how to respond

November 11, 2010

 

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.

October 28, 2010

 

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, September 2010

FDA Publishes Guidance on Capillary Electrophoresis

This guidance has been published as Annex 11.  It is one in a series of  documents that describe the evaluations and recommendations by the ICH Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. The ICH Steering Committee recommends that the analytical procedures described in the official pharmacopoeial texts, Ph. Eur. 2.2.47. Capillary Electrophoresis, JP General Information. Capillary Electrophoresis, and USP General Information Chapter <1053> Biotechnology-derived Articles – Capillary Electrophoresis,  can be used as interchangeable in the ICH regions. To download the guidance, click here.

Free 28-page White paper on Supply Chain Security from ISPE

Supply chain security is a chief concern throughout the pharmaceutical industry.   “Supply Chain Security: A Comprehensive and Practical Approach” illustrates how an integrated approach can help address pharmaceutical supply chain security concerns, such as preventing and detecting adulteration, counterfeiting, illegal diversion, and theft. The white paper is available as a free download via the ISPE Web site, www.ispe.org

FDA Warning Letter for Inadequate Validation of Analytical Methods

The FDA expects analytical methods to be validated and chemists in the receiving laboratory should formally trained when methods are transferred.  This became obvious during a recent FDA inspection which resulted in a 483 with 24 observations. Several observations were related to inadequate method validation and transfer. For example: "The analytical method has not been transferred between the issued laboratory and the two chemists currently working in the QC laboratory. The methods have been transferred before the two chemists were hired. There are no records which document training in the two procedures". "There are no records which document validation for one or more of the following areas of analysis: Assay by HPLC, assay by titrimetry, and water determination by IR spectrophotometer". "The suitability of all testing methods is not verified under actual conditions of use" and "The HPLC configuration tubing at the time of method validation may not be similar to actual ones used possibly affecting the resolution". The 483 can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-241.  To learn everything about FDA requirements for HPLC method development and validation  attend the audio seminar  "Effective HPLC Method Development and Validation".

FDA Publishes Questions and Answers on Product Recall

As part of the cGMP related Q&A series the FDA published answers to frequently asked questions related to product recalls. Examples for questions are: What is a recall? Can FDA mandate  a recall of human drugs?  Are OTC drugs subject to the same recall provisions as prescription drugs? What happens if a firm does not voluntarily recall a defective product? Does FDA expect firms to investigate both released and rejected lots for potential recalls? To see all Q&As, click here

Free FDA Web Seminar about Generic Drugs

On Monday, September 27th, 2010, at 1:00PM ET, The U.S. Food and Drug Administration (FDA) will host a webinar that answers questions about the agency’s work with generic drugs. After the presentation, there will be an opportunity to ask questions. To join the meeting September 27th: 1. Click the following URL – https://collaboration.fda.gov/genericdrugs. 2. Click on the “Enter as a Guest” button, fill in your name, then click “Enter Room”. Materials from the webinar will also be available on the FDA website. To download presentation slides, click on: Generic Drugs

FDA Warning for Inadequate Storage of Reference Samples and Reagents

Reference Samples and reagents should be stored according to manufacturers recommendations to maintain the required quality. FDA verifies storage conditions during inspections This became clear during an inspection of a drug manufacturer which resulted in a 483 with 12 observations. Examples are: "Laboratory records do not include complete records of any testing and standardization of laboratory reference standards and reagents". "Biological Indicators were observed to be stored in Refrigerator on 06/22/10, which is not being monitored for storage at xx% RH as per manufacturers instructions" "Reagents were not logged into a drying Oven Log Book and were observed on 06/22/10 in the analytical room testing area desiccator. Reagents were stored in a crucible sealed with paraxin". The 483 can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-239.  To learn about FDA requirements for reference samples attend the audio seminar "FDA Compliant Use of (Certified) Reference Material".

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 "Data backup and Restore". To download your free copy, go to the ISO 17025 Laboratory Accreditation Package website. Scroll down and click on the corresponding ICON on the left (offer expires on October 4, 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

 

  1. FDA Compliant Use of (Certified) Reference Material
    With 10+ Best Practice Guides for Easy Implementation
    October 7, 2010
  2. Effective HPLC Method Development and Validation
    Preparation, conduct and documentation for FDA/EMA Compliance
    October 21, 2010
  3. Validation of Excel® Spreadsheets for Regulated Environments:
    Step-by-Step

    With Case Studies and Validation Protocols for Easy Implementation.
    October 28, 2010
  4. How to Prepare Yourself for FDA's New Part 11 Inspection Program
    Learn what the FDA is looking for and how to respond
    November 11, 2010

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