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Labcompliance News, March 2005

March 15, 2005

15 New Documents in the Labcompliance Users Club

This month Labcompliance has added 15 new documents to the usersclub. New documents include: 6 SOPs, 2 checklists/gap analyses, 1 video clip, 1 new regulatory computer guideline, 6 FDA warning letters. The new documents can be downloaded from the Labcompliance Usersclub. For information and registration, click here.

March 15, 2005


New Article: Analytical Technology Moving from the Lab to the Line

Recently instrumentation companies have made strides to bring analytical technology from the laboratory into the pharmaceutical processing line. This process is driven by the need for higher productivity. FDA is supporting this trend through the PAT initiative as part of the 21st century drug cGMP initiative. Pharmaceutical technology has written a special report related to this topic. The report describes miniature spectrometers, microfluidics and other new technologies. It also describes how the availability of sensors combined with more robust wireless technologies will help to efficiently monitor and control pharmaceutical processes. The big questions still remain: how soon can the new technologies be brought into the process environment and to what extent they will replace traditional pharmaceutical quality control analyses.

March 15, 2005

No Backup Procedures and No Validation of Computer Systems and Draw FDA Warning Letter

"The firm’s computer software programs which operate all of the lab during the analysis of raw materials and xxx finished product, have not been qualified and/or validated", and "The software programs do not secure files from accidental alteration or losses of data. The functions that modify and delete partial or whole data files are available for use by all analysts." In addition, the firm has not established any security procedures for the laboratory computer systems. There are no procedures for backing-up data files and no levels of security access established", have been amongst the deviations cited in an FDA warning letter. The FDA also found that there was the firm has not established any security procedures for the laboratory computer systems. The Warning Letter further noted that the process validation for the product Syncro-Mate-B Implants is inadequate in that the firm’s retrospective validation report evaluated batches that were manufactured and tested at a different manufacturing facility. The firm failed to perform any new process validation or revalidate the manufacturing process, at your current site. Additionally, the firm failed to validate the testing methods used to analyze the batches in the retrospective validation report and the equipment used to manufacture and test the validation batches was never qualified. The warning letter can be downloaded from the Labcompliance Usersclub (138). Non members can preview excerpts.

March 15, 2005

Links to 30 International GMP Regulations and Guidelines

Healthcare products marketed to a specific country should comply with GMP regulations of that country, no matter where the products have been developed and manufactured. Unfortunately GMPs are not identical within all countries. Understanding the regulations and guidelines of target countries is the first step towards compliance. Labcompliance has developed a new site with 30 links to national and international cGMP regulations and guidelines. They include Europe, Australia, ICH, WHO and others.

March 1, 2005

New Article: Method Development of Swab Sampling for Cleaning Validation of a Residual API

Cross contamination with active ingredients is a real concern. Cleaning validation is required in the pharmaceutical field to avoid potential clinically significant synergistic interactions between pharmacologically active chemicals. Since the issuance of the US Food and Drug Administration’s "Guide to Inspection of Validation of Cleaning Process" in July 1993 (3), cleaning validations have received increasing attention. Validation is required not only for manufacturing sites, but also for the sampling–filling suite in research and development. The two main sampling techniques available for cleaning validation are rinse and swab sampling. Pei Yang, and co-workers have developed a swab-sampling method or cleaning validation of a residual active pharmaceutical ingredient in samples collected after cleaning the sampling suite. A summary of the strategies and results of the method development is presented.

March 15, 2005

New FDA Guidance on Changes to an Approved NDA or ANDA

On November 22, FDA published the "Guidance for Industry: Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes". With this Guidance FDA reacts to the communication of NDA and ANDA holders requesting clarification regarding the final rule Supplements and Other Changes to an Approved Application. .

March 15, 2005

New Newsletter Category: Free Document of the Month

As a 'Thank You' for our Newsletter Subscribers Labcompliance offers every month one document for free. This month's document is entitled
"SOP: FDA Inspections: Preparation, Conduct, Follow-up" which is one of the most important SOP at all. The document is available for 30 days.

March 2005

On-line Audio Seminars: New Service from Labcompliance

Now Labcompliance provides basic and on-going updated information on validation and compliance through on-line audio seminars. With this new service you can learn from the convenience of your desk or with your colleagues in your seminar room. Click here to learn what audio seminars are, what the benefits are, which topics are available and the dates, how you can register and how the information is delivered. The first one on "Strategies for Cost Effective Network Compliance and System Uptime" has been delivered with great feedback from the audience.