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System Suitability Testing for FDA and USP Compliance

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FDA Regulations for (Bio)Pharmaceutical Industry

Get an Overview on Principles and Key Requirements in just one Hour

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FDA Compliant Use of (Certified) Reference Material

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Effective HPLC Method Development and Validation

Preparation, conduct and documentation for FDA/EMA Compliance

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Analytical Instrument Qualification According to USP <1058>

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2010 

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

 

 

Labcompliance News, July 2010

New FDA Draft Guidance on CMC Post-approval Changes

This guidance provides recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes that may be reported in annual reports. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) post-approval manufacturing changes that FDA has determined will likely present minimal potential to have adverse effects on product quality and, therefore, may be reported by applicants in an annual report. To download the guidance, click here.

'Spreadsheet Calculations Not Verified'  Cited in FDA Warning Letter

The company "Released products based on assay results generated by the spreadsheet that have not been verified for accuracy". In addition the laboratory records did not include a record of all calculations performed in connection with laboratory tests as required by 21 CFR §211.194(a)(5). For example, "The notebook did not document reference to the spreadsheet calculation used to generate the results". This is just another example that FDA pays attention about and enforces software validation. Other violations included 'Batch record raw data written in pencil , erased and rewritten', 'Corrective action not extended to other batches',  'Inadequate review of batch records' and 'Root cause for OOS not investigated'. The Warning Letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-237.  Learn all about FDA requirements and recent warning letters related to computer system and Part 11 compliance in the upcoming Labcompliance audio seminar. To learn everything about FDA's expectations for validation of spreadsheets, click here.

The UK MHRA Updates Guidance for Stand Alone Contract Laboratories


This document
is targeted to UK Manufacturer’s License and Manufacturer’s Authorization (for Investigational Medicinal Products) Holders.
The document

  •  Defines a stand alone contract laboratory in relation to quality control testing of medicinal products.
  • Provides guidance as to when a contract laboratory must be named on a manufacturer’s license for relevant medicinal products for human and veterinary use and/or a manufacturer’s authorization for investigational medicinal products.
  • Is applicable to all manufacturing license holders, i.e. import, export, herbals and specials.
  • Provides guidance as to when a contract laboratory is not required to be named on a manufacturer’s license or authorization.
  • Outlines the MHRA’s criteria for inspection of contract laboratories.

FDA Announces New Inspections with Focus on Part 11

The US FDA will be conducting a series of inspections related to 21 CFR Part 11 and intends to take appropriate action to enforce Part 11 requirements. The announcement was made on the FDA Website on July 8, 2010. The inspections are part of an effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 ‘Part 11, Electronic Records; Electronic Signatures - Scope and Application’ guidance. As a matter fact the FDA has been enforcing Part 11 since three years ago. This is demonstrated through more than 30 warning letters with deviations related to Part 11. Attend the new Labcompliance Audio Seminar: Recent Warning Letters and 483's Related to Computer Validation and Part 11 to learn everything about FDA's current inspection practices. More information about the upcoming  inspection assignments has been provided by FDA's national Part 11 expert George Smith and will be available through the Labcompliance audio seminar: Understanding and Preparing for FDA's New Part 11 Inspection Program.

Free FDA Training on Human Drug Regulation

The US FDA offers a free a on-line training course with the title: "The Past, Present, and Future of FDA Human Drug Regulation". The program gives health care professionals, industry, consumers, and all other interested participants an overview of the human drug regulatory process in the United States. The training includes video and text material and lasts about 90m minutes.. For registration, click here.

FDA Warning for Missing Verification of Expiration Date Calculation

FDA inspectors are getting more and more specific when inspecting software and computer systems. This became obvious during a recent inspection of a pharmaceutical manufacturer. The company used software to calculate expiration dates and not verify the accuracy of calculations. "Your firm failed to check the accuracy of the input to and output from the computer or related systems of formulas or other records or data and establish the degree and frequency of input/output verifications [21 CFR § 211.68(b)]. - For example, the performance qualification of your xxx systems software failed to include verification of the expiration date calculations in the xxx system ." Other deviations included: SOP for laboratory testing not followed, no timeline for equipment qualification, OOS not conducted according to SOP, inadequate failure investigation, root cause not determined, expiration dates not supported by stability data, inadequate complaint handling. -The Warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-238.  To learn about and to download 30 other Warning Letters related to computer validation and part 11 compliance  attend the Labcompliance audio seminar "Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11".

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 53-page Laboratory Compliance Manual. To download your free copy, go to the Laboratory Compliance website. Scroll down and click on the corresponding ICON on the left (offer expires on July 30, 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. 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, available at any time
  2. Understanding and Preparing for FDA's New Part 11 Inspection Program
    With 10+ Best Practice Guides for Easy Implementations
    Recorded, available at any time
  3. Effective HPLC Method Development and Validation
    Preparation, conduct and documentation for FDA/EMA Compliance
    Recorded, available at any time

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