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FDA Globalization Act of 2008: More Fees, More Inspections (203)
Understanding the impact on domestic and international companies

July 31, 2008

 

Effective Training Practices for FDA Compliance
What to train - How much to Train - How to Document Effectiveness
Sept 4, 2008

 

Understanding the New USP <1058> for Analytical instrument Qualification

With SOPs, Templates and Examples for Easy Implementation

Recorded

 

Verification of Compendial Methods

With SOPs, Templates and Examples for Easy Implementation

Recorded

 

NEW BOOK EDITION

Dr. Ludwig Huber

 

 

Labcompliance News, July 2008

USP Chapter <1058> on Analytical Instrument Qualification Release on Aug 1

On August 1, 2008, USP releases it's final version of the general chapter: Analytical Instrument Qualification. As all general chapters with numbers above 1000 the chapter has the status of recommendations. Nevertheless the pharmaceutical industry is advised to implement the recommendations because they are in line with FDA's thinking and expectations for equipment calibration and qualification, And the chapter becomes mandatory when a USP monograph requires to qualify equipment as a prerequisite to run the test. Click here to find more information on the content and how to get SOPs and other documents for easy implementation.

ICH Guideline Q10 "Pharmaceutical Quality System" Released

On June 6, 2008, ICH released the final version of it's Guideline Q10 "Pharmaceutical Quality System. ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Standards Organisation (ISO) quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”. ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. 

Wrong Interpretation of USP Chapter <1226> Cited in FDA Warning Letter

The USP general chapter on the Verification of Compendial Methods has been released in December 2007. The chapter includes a statement that "Verification is not required for basic compendial test procedures that are routinely performed unless there is an indication that the compendial procedure is not appropriate for the article under test". The company used a USP method but did not verify assuming it was basic compendial test method. On the other hand the FDA stated in the warning letter: "We disagree with your assertions that verification is not required for those USP test methods used by your firm". The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 213). Learn all about USP <1226> and get SOPs and other documents for easy implementation in a Labcompliance Audio Seminar 

ICH Q3A Guidance "Impurities in New Drug Products" Revised

This is the second revision of the Q3A guidance, which was published in 1996 and revised in 2003. The document is intended to provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state. Impurities in new drug substances are addressed from two perspectives:

  • Chemistry aspects include classification and identification of impurities, report generation, listing of impurities in specifications, and a brief discussion of analytical procedures
  • Safety aspects include specific guidance for qualifying those impurities that were not present, or were present at substantially lower levels, in batches of a new drug substance used in safety and clinical studies.

The guidance can be downloaded from the FDA website

FDA Warning Letter Issued for Not Verifying Software Design Changes

A device manufacturer was cited for not verifying design changes of software. For example, the letter states: "Failure to establish and maintain procedures for the identification, documentation, validation or verification, review, and approval of design changes before their implementation. There were no validation test protocol and test results to verify the effectiveness of the software design changes". Furthermore, the company was cited for no revalidation after software change, no safety risk analysis, inadequate software test protocols and procedures and for inadequate incoming product testing. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 202). Learn all about FDA compliant software and computer system validation and get master plans, SOPs and other documents for easy implementation with the Labcompliance Computer System Validation Package.

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: Archiving of GLP Data and Other Documents. To download your free copy, go to the GLP Tutorial, scroll down and click on the corresponding ICON on the left (offer expires on August 2008). Labcompliance offers more than 100 SOPs. For titles and ordering, click here.

New Audio Seminars - Updated Schedule

  1. FDA Globalization Act of 2008: More Fees, More Inspections (203)
    Understanding the impact on domestic and international companies
    July 31, 2008
  2. Effective Training Practices for FDA Compliance
    What to train - How much to Train - How to Document Effectiveness
    Sept 4, 2008

IVT Conferences

  1. IVT's 5th Annual
    Method Validation Conference
    October 14-16, 2008
    Hyatt Fisherman's Wharf in San Francisco, CA.
  2. IVT
    Computer System Validation
    October 14-16, 2008
  3. IVT
    PharmSep Symposium
    September 9-11, 2008
    Pennsylvania Convention Center, Philadelphia, PA

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