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

 

Measurement Uncertainty in Chemical Analysis
With tools to comply with ISO17025 Standard and FDA expectations
Recorded

 

Management and Validation of Computers for ISO 17025
Requirements, Recommendations and Tools for Implementation
Recorded

 

IT Infrastructure and Network Qualification
Introduction and Strategies for Compliance and System Uptime
Recorded

 

Traceability in Chemical Analysis
With strategies and tools for ISO 17025 and FDA Compliance
Recorded

 

Effective Verification of Compendial Methods
Understanding USP and FDA Requirements and get Tools for Implementation
Recorded

 

Auditing Laboratories for FDA and ISO 17025 Compliance
Preparation - conduct - follow up - documentation
Recorded

 

Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control
Comply with the FDA and international guidances
Recorded

 

Validation and Use of Excel® Spreadsheets in Regulated Environments
With FDA's
Dennis Cantellops

Recorded

 

Labcompliance News, February 2009

FDA Introduces Globalization Act of 2009

On April 17, 2008, a discussion draft for an "FDA Globalization Act of 2008"  has been released, and a revised version of the draft has been published in July. The Discussion Draft was meant to stimulate discussion about how to provide adequate funding and authority for FDA to ensure the safety of the Nation's food, drug, medical device and cosmetic supply in an increasingly globalized marketplace. For details see Labcompliance News from June 2008. After approval it will go to the House for voting. Then the Senate will vote and after that it is forwarded to the president and is signed into law. For pharmaceutical, API and device manufacturers the act means: New fees, more inspections, more documentation, To get a good understanding on all details click here

FDA's Spreadsheet Expert Answers Questions on Excel Validation

On February 12 Dennis Cantellops joined the Labcompliance audio seminar: Using Excel in Regulated Laboratories. Dennis is QA manager at the FDA Laboratory San Juan, and main author of FDA's  two Information Bulletins on Design and Validation of Spreadsheets. Dennis explained FDA's approach on how to design, develop, validate and use Excel spreadsheets in FDA regulated environments.  He also answered the many questions from the audience. Most frequently asked questions were about the type and extend of testing, how to make out-of-the box Excel Part 11 compliant, when do we need electronic audit trail, and what type of data should be reviewed in routine use. To learn about FDA's approach and to get answers to the questions, download the recorded Audioseminar.

 

Revision of the PIC/S GMP Guide

The PIC/S GMP Guide (PE 009-8) has been revised in parallel with the EU GMP Guide.

The following changes were made:

  • Chapter 1 (Part I) has been revised in order to include aspects of quality risk management within the quality system framework.
  • Annex 1 has been revised in order to align the classification table for environmental cleanliness of clean rooms with ISO standards and to provide supplementary guidance on the application of the principles and guidelines of GMP to sterile medicinal products,
  • A new Annex 20 has been adopted in order to implement the ICH Q9 guideline on Quality Risk Management. This Annex is voluntary

The revised PIC/S GMP Guide will enter into force on March 1, 2009. It is now available for downloaded from the PIC/S website

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FDA Guidance: Standardized Numerical Identification for Prescription Drugs

On Jan 22 the FDA released the Industry Guidance: Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages. The guidance is intended to address provisions set forth in Section 505D of the Federal Food, Drug, and Cosmetic Act (the act) regarding development of standardized numerical identifiers (SNIs) for prescription drug packages. In this guidance, FDA is identifying package-level SNIs, as an initial step to facilitating other measures for securing the drug supply chain.

FDA CDER Plans for New Guidances in 2009

The US Food and Drug Administration (FDA) has published a list of guidances CDER is planning to develop during calendar year 2009. Amongst them are guidances for "Contract Manufacturing", "21 CFR Part 11", "Pharmaceutical Component Quality Control" and "Content and Format of the Clinical Pharmacology Section". 

New FDA Guidance Refers to ISO/IEC 17025 for Laboratory Testing

For the first time the FDA refers to ISO 17025 in an industry guidance: "Submission Of Laboratory Packages By Accredited Laboratories". The new guidance comes into effect when the FDA denies regulated products (biological products, food, drugs, devices) from import into the United States. In this case the importer has to provide full laboratory packages to demonstrate compliance. In addition most likely the product will be tested in FDA laboratories. Importers now have the option to provide   abbreviated laboratory packages if testing was performed in an accredited laboratory, Advantage for the FDA are: less resources are required for extensive review of the full package and for laboratory testing. Main advantage for the importer is faster import approval. According to the guidance accreditation should be assessed in conformance with ISO/IEC 17025 as  "The most widely used laboratory standard for federal testing laboratories, including FDA’s own laboratories". In our opinion this is just the first step to leverage ISO 17025. For example, FDA's new Globalization Act  requires all imported products either to be entered into United States through a port of entry that is located in a metropolitan area with federal testing laboratory or to provide documentation demonstrating compliance with identity/purity requirements 'certified by an accredited third party'. The last step may be that the FDA offers the option for all product testing as required by GLP, GCP and cGMP: reduce FDA review time and FDA testing through demonstrating conformance with ISO 17025. Labcompliance is well prepared for this move. We have  a lot of  tools to get  a good understanding and for implementing ISO 17025. Examples are
- A free
Tutorial
- Audio seminar: Effective Gap Analysis for ISO 17025
- Audio seminar: Understanding and Implementing ISO 17025
- ISO 17025 Accreditation Package with an example quality plan and 30+ procedures
- One day workshop, for example, on March 20 2009 in Hanoi, Vietnam

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 Checklist: ISO 17025 Accreditation . To download your free copy, go to the ISO 17025 Tutorial, scroll down and click on the corresponding ICON on the left (offer expires on Mar 15, 2009). Labcompliance offers more than 100 Examples that help to complyy with FDA and ISO 17025 compliance. For titles and ordering, click here.

ISO 17025 Workshop at Analytica Vietnam

Analytica Conference
Understanding and Implementing ISO 17025
March 20, 2009, Hanoi, Vietnam
One day workshop with Dr. Ludwig Huber
Learning through examples: 50% of the time will be dedicated to case studies
Very attractive pricing: $50,
The seminar includes the download version of the Laboratory Compliance Package from Labcompliance (regular price: US$ 579)

New Audio Seminars - Updated Schedule

  1. Measurement Uncertainty in Chemical Analysis
    With tools to comply with ISO17025 Standard and FDA expectations
    Recorded, available with reference material at any time
  2. Management and Validation of Computers for ISO 17025
    Requirements, Recommendations and Tools for Implementation
    Recorded, available with reference material at any time
  3. IT Infrastructure and Network Qualification
    Introduction and Strategies for Compliance and System Uptime
    Recorded, available with reference material at any time
  4. Traceability in Chemical Analysis
    With strategies and tools for ISO 17025 and FDA Compliance
    Recorded, available with reference material at any time
  5. Effective Verification of Compendial Methods
    Understanding USP and FDA Requirements and get Tools for Implementation
    May 14, 2009
  6. Auditing Laboratories for FDA and ISO 17025 Compliance
    Preparation - conduct - follow up - documentation
    Recorded, available with reference material at any time
  7. Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control
    Comply with the FDA and international guidances
    Recorded, available with all reference material at any time

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