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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


Cost Effective Software and Computer System Validation
Take Advantage of New Recommendations from FDA, EU Annex 11 and GAMP® 5
July 24, 2008


Understanding the New USP <1058> for Analytical instrument Qualification

With SOPs, Templates and Examples for Easy Implementation




Dr. Ludwig Huber



Labcompliance News, June 2008

"FDA Globalization Act of 2008": New Fees, More Inspections, More Documentation

Based on inputs from different groups a discussion draft for an "FDA Globalization Act of 2008"  has been released on April 17, 2008.. The act should significantly increase FDA's resources and power for overseeing foreign drug and API manufacturers and import quality. Recommendations include a registration fee for domestic and foreign manufacturers to fund inspections, initial and regular inspections of all facilities with drug, device and API manufacturing, establishment of dedicated foreign inspectorates, import of drugs through areas with FDA testing laboratories or documented product testing through accredited laboratories, and identification and better documentation of origins of APIs. Click here to find more information on the content and how to get the discussion daft. Attend the Labcompliance audio seminar to get a good understanding and recommendations for implementation.

"Spreadsheets and Other Software Not Validated" Cited in FDA Warning Letter

Spreadsheet applications such as Excel are software and as such should be validated. This became during an inspection of a device manufacturer. The company used spreadsheets to check for outliers and calculate mean, SC, % CV, value assignments for finished devices. The FDA stated that software used as part of the production quality system was not validated for its intended use according to an established protocol [21 C.F.R. 820.70(i)]. Furthermore the FDA found other deviations, e.g., implementation of corrective action too late, no procedures to ensure the quality of incoming products, CAPA not documented, CAPA not documented. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 201). Learn how to validate Excel spreadsheets in a Labcompliance Audio Seminar

EU Guidance for the Conduct of Good Clinical Inspections

The scope of this guidance is to provide unified standards on the conduct of GCP inspections that are applicable for any site to be inspected. This guidance takes into account the following procedures: 1) Guidance for preparing for GCP inspections’ which describes the steps immediately before the conduct of an inspection and particularly the inspection plan. 2)‘Procedure for reporting on GCP inspections’, which describes the contents of GCP inspection. The guidance has sections on the opening meeting, conduct of the inspection, collecting information, documenting the inspection, writing inspectional observations and on the closing meeting.

 FDA Hiring Initiative for its Public Health Mission

The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation. In fiscal year 2008 alone, the FDA is looking to fill more than 600 new positions and to backfill over 700 others to implement the FDA Amendments Act of 2007, the Food Protection Plan and the Import Safety Action Plan. That's nearly triple the number of people hired from 2005-2007For more articles from the publisher, According to a press release the critical need occupations are medical officers, consumer safety officers, chemists, nurse consultants, biologists, microbiologists, health/regulatory/general health scientists, mathematical statisticians, epidemiologists, pharmacologists, pharmacists and veterinary medical officers. To read the FDA press release click here

New FDA Guidance on Regulatory Submissions in Electronic Format

This is one in a series of guidance documents intended to assist applicants making regulatory submissions to the FDA in electronic format using the electronic common technical document (eCTD) specifications. This guidance discusses issues related to the electronic submission of applications for human pharmaceutical products2 and related submissions, including abbreviated new drug applications (ANDAs), biologics license applications (BLAs), investigational new drug applications (INDs), new drug application (NDAs), master files (e.g., drug master files), advertising material, and promotional labeling.3 At this time, this does not include applications supporting combination products.
This guidance revises the guidance of the same title that was issued in October 2005 and revised in April 2006.

Labcompliance Conducting the 100th Audio Seminar

Thousands of professionals from over 100 companies have attended the Labcompliance Audio seminars since the first launch in December 2002. On July 2, 2008, we celebrate our 100th seminar. The topic will be on GMP Compliance for Laboratories. As a "Thank You" for their on-going support all registered attendees can choose at no additional charge one of the five video seminars that have been introduced by Labcompliance (Value $449). All 100 audio seminars have been recorded and are available with all reference material.

 EU Guidance for Exchange of GCP Inspection Reports

On May 28 the European Commission published a guidance document containing the common provisions on the conduct of GCP inspections by competent authorities of the member states. Inspection documentation is confidential and sensitive. Therefore exchange of inspection reports is restricted and only allowed under certain circumstances
The new guidance describes the process of request, release and transmission of GCP
inspection reports between the Competent Authorities of the Member States of the European Union. 

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: Quality Assessment of Software and Computer System Suppliers. To download your free copy, go to the Computer System Validation Tutorial, scroll down and click on the corresponding ICON on the left (offer expires on July 10, 2008). Labcompliance offers more than 100 SOPs. For titles and ordering, click here.

New Audio Seminars - Updated Schedule

  1. FDA/EU cGMP Compliance for Laboratories
    Requirements and Tools for Implementation
    Wednesday, July 2, 2008
  2. Out-of-Specification Data Trending
    GMP requirements and tools for implementation
    July 3, 2008
  3. Cost Effective Software and Computer System Validation
    Take Advantage of New Recommendations from FDA, EU Annex 11 and GAMP® 5
    July 24, 2008

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