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Labcompliance News, June 2006

June 16 , 2006

How to Predict the Future of 21 CFR Part 11

In March of 1997 the FDA issued final Part 11 regulations that provide criteria for acceptance by the FDA of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures. After Part 11 became effective in August 1997, significant discussions did start amongst industry, contractors, and the Agency concerning the interpretation and implementation of the regulations. While initial FDA guidance documents indicated a very broad scope with significant problems to fully implement Part 11, in 2003 the FDA released a new guidance promoting a more narrow scope. The FDA also announced to rewrite the regulation itself. This was scheduled for 2005 but has been delayed until second half of 2006. To learn how the future of Part 11 can be predicted and how to prepare your organization for the new Part 11 click here.

June 6 , 2006

FDA Withdraws or Changes Seven Industry Guidances

On June 1 the Food and Drug Administration (FDA) announced the withdrawal of five and the revision of two guidances for industry, because some of the principles in these guidances are inconsistent with
the agency's initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century (CGMP Initiative). Several of the guidances listed in this notice are cross-Center guidances relating to products regulated by the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Veterinary Medicine (CVM). The FDA also announced to continue to review FDA guidances for their consistency with the CGMP Initiative and may withdraw or revise other guidances if they do not reflect our current thinking or to align them with the concepts of the CGMP Initiative. In the meantime the FDA recommends that the human drug pharmaceutical industry refer to (ICH) documents, which are available on FDA's Web
sites, as alternate resources.

June 5 , 2006

Inadequate Equipment Qualification Draws 14 Item FDA Warning Letter

The warning letter, issued in April 2006 cited the firm for many cGMP violations related to equipment qualification. The letter includes lots of details on FDA expectations that you can not find in FDA guidance documents and even less in regulations. Citations included: PQ protocol missing, validation protocol not followed, IQ/OQ not performed. Most interesting was a quote about missing forms to record IQ information as required by an SOP: "The forms contained in the SOP are not designed to allow recording of the information that they are required to contain under the SOP. For example, there are no provisions in the form to record or check the specifications against which the Installation Qualification (IQ) is to be performed". Other violations included inadequate cleaning validation procedures, missing failure investigation, master production and control records not signed, inadequate washing facilities, insufficient testing and missing preventive maintenance, The Warning Letter can be downloaded from the Labcompliance Users Club. Non members can preview excerpts. Labcompliance has conducted a seminar equipment qualification following a new USP chapter.

June 5, 2006

Joint Workshop on Validation In Laboratories by FDA's Nicholas Buhay and Dr. Ludwig Huber

Nicholas Buhay, Deputy Director, Office of Compliance, CDER, FDA, and Ludwig Huber, editor of Labcompliance, gave a joint workshop on Validation in Analytical Laboratories at the joint US FDA/ISPE industry cGMP training in Beijing, China. The workshop was followed by two 90 minutes Q&A sessions. The workshop covered all validation and other compliance activities in Laboratories. It started with expectations for quality systems and documentation control requirements and continued with expectations for sampling, sampling plans, sample handling, testing and reporting and archiving of test results.

June 5, 2006

FDA Publishes ANDA Checklist for CTD and eCTD Format

This new checklist is recommended to verify filing of ANDA Applications for completeness and acceptability.

June 5, 2006

GAMP Good Practices Guide for Validation of Laboratory Computer Systems

The "GAMP Guide for Validation of Automated Systems (GAMP 4)" is recognized as industry standard for computer validation. While this guide is an excellent framework for computer validation in general it is not detailed enough for specific applications, for example, laboratories. On the other hand because of their criticality laboratory computers are right on target of FDA inspections. To close the gap ISPE/GAMP has developed a special Good Practice Guide (CPG) for laboratory computer systems "ISPE/GAMP Good Practices Guide: Validation of Laboratory Computerized Systems, 2005 ". The guide is expected to be the single most important reference for automated laboratory systems from stand alone automated systems to complex networked systems and the FDA and EU agencies are using GAMP guidance as reference. To learn more about the guide read the Agilent Exclusive Monthly Compliance News and receive a free SOP or register for the Labcompliance Audio Seminar.

June 5, 2006

USP Senior Chemist Spoke About The Analytical Instrument Qualification Chapter

Horacio N. Pappa, Ph.D, from the USP Department of Standards Development gave an update on the new USP general chapter <1058>: "Analytical Instrument Qualification" at the London IVT conference: Laboratory Regulations, Controls and Compliance. Dr. Pappa started with a list of recent FDA Warning Letters/483's and then talked about the 3rd draft that has just been published in April. Some key points: The chapter will use the lifecycle approach with risk based approaches to provide flexibility in the qualification process. Dr. Pappa gave details on the life-cycle steps, such as DQ, IQ, OQ and PQ with a nice overview on timing, applicability and activities for each phase. One key point: Firmware is considered to be part of equipment hardware and does not need separate qualification but requires full version control. The final version is expected to be released in 2007, but now is a good time to learn about the chapter in more detail and start to implement. The presentation can be downloaded from the Labcompliance Usersclub. For preview and registration to the Userslub, click here. The presentation is also available on the Labcompliance AIQ seminar website. For more information on this seminar, click here

June 5, 2006

FDA to Charge Industry for Reinspection

If manufacturers receive a follow-up inspection from FDA, they'd better be ready to pay for it. The agency has proposed $22 million in mandatory user fees that would require the companies it reinspects to foot the bill for the visit. The new fees are part of the President Bush's fiscal year 2007 budget request. Many manufacturers haven't been happy with user fees for PMA and 510(k) reviews, and it's not likely that they will be pleased with a new round of expenses either.

June 5, 2006

New Publication on Using Spreadsheets in cGMP Environments

After a brief introduction on benefits and applications of spreadsheets in pharmaceutical manufacturing and quality control the focus of this article is on hazards of using spreadsheets in a good manufacturing practice (GMP) environment. One of the big advantages is the ease of use and people with basic skills in software development can achieve a lot with little effort, but also is the greatest hazard. Using practical examples, the author Anders Keldsen gives advice on when to use spreadsheets and when to employ a proper software application. The author gives also advice on how to maintain security controls. The article has been published in PharmTech Europe. To learn more about using spreadsheets in regulated environments, click here.