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Understanding and Preparing for FDA's New Part 11 Inspection Program

With 10+ Best Practice Guides for Easy Implementations



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



Effective HPLC Method Development and Validation

Preparation, conduct and documentation for FDA/EMA Compliance



Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation



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



Labcompliance News, June 2010

EU Guidance on Classification of Medical Devices Updated

This document is a revision of an earlier document published in July 2001 as MEDDEV 2.4/1 rev 8. It includes information pertaining to the changes in classification resulting from the amending and implementing Directives issued since the last revision of this document in 2001. The guidance takes a 'risk'  approach for classification based on the vulnerability of the human body taking account of the potential risks associated with the devices. This approach allows the use of a set of criteria that can be combined in various ways in order to determine classification, e.g. duration of contact with the body, degree of invasiveness and local vs. systemic effect. These criteria can then be applied to a vast range of different medical devices and technologies. To download the guidance, click here.

New Spreadsheet Quality Package Available as Download

The popular Macro & Spreadsheet Quality Package is now available as download version, in addition to traditional CD/Binder Version. The content has also been updated with new SOPs and 10 Excel validation examples documents. The package includes 13 SOPs, master and project plans, 15 examples/forms/templates. It also includes a new audio seminar with FDA's Dennis Cantellops and Dr. Ludwig Huber.   The package helps to develop strategies for validating and using Excel in FDA and other regulated environments and it has the tools for trouble free implementation. For details on content and ordering, click here.

Genzyme Corp. Signs Consent Decree to Correct Manufacturing Quality Violations

Genzyme Corp. has signed a consent decree agreeing to correct manufacturing quality violations at its Allston, Mass., manufacturing facility and will turn over to the federal government $175 million in unlawful profits from the sale of products that were made at the plant, the U.S. Food and Drug Administration announced in a on May 24. During an inspection of the Allston plant FDA inspectors found that the company's systems for ensuring manufacturing quality were inadequate resulting in production delays, critical shortages of medically necessary products to consumers and drugs contaminated with metal, fiber, rubber and glass particles. These manufacturing problems violated the FDA’s regulations for manufacturing practice. Under the consent decree the company agreed to adhere to a strict timetable to bring the plant in line with the regulatory requirements of the FDA.. To see the full article, click here

PIC/S Assessment of FDA Membership Targeted for the Next Comittee Meeting

The PIC/S Committee met in Geneva (Switzerland) on 19-20 May 2010. Following discussions with an FDA delegation, composed of representatives of CDER and ORA1, the Committee has agreed to make a follow-up visit to the USA in August 2010 in order to review the outstanding issues. The assessment team will come up with a recommendation regarding FDA’s accession to PIC/S in time for the next Committee meeting. To see the full meeting report, click here.

Software Testing Raw Data not Saved Cited in FDA Warning Letter

The company has tested software and entered the test results into a computer system. The letter reads: "Verification and Validation report for software version 2.0 is not available for review. According to your employee, once the results are
entered into your electronic report, the raw tests data are discarded. Therefore, you have no evidence the sequence testing was performed." This warning letter is an other example for FDA's focus on software validation and associated records. Other violations included 'incomplete test data', 'compliant handling procedures not implemented', 'servicing procedures not implemented', and 'inadequate training of personnel' The Warning Letter can be downloaded from the Labcompliance Usersclub. Non members can preview
excerpts. Scroll down to W-236.  Learn all about FDA inspections and recent warning letters related to computer system and Part 11 compliance in the Labcompliance audio seminar.

 New Template for API Quality Agreements

The template has been developed by the Bulk Pharmaceuticals Task Force BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA). The template provides guidance for drafting agreements relating to the manufacture and release of FDA regulated drug substances. For more information read SOCMA's press release. To download the 19 page template, click here.

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 Back-up and Restore. To download your free copy, go to the Spreadsheet Compliance website.  Scroll down and click on the corresponding ICON on the left (offer expires on June 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. Analytical Instrument Qualification According to USP <1058>
    With SOPs, Templates and Examples for Easy Implementation
    July 8, 2010
  2. 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
    July 22, 2010

2-Day Workshop


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