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Labcompliance News, April 2007

April 16, 2007

Labcompliance Offering Interactive Courses - Worldwide

Labcompliance offers a new service which is class room courses for topics related to FDA and equivalent international compliance. Topics range from basics of GLP and GMP to special topics such as equipment qualification and software and computer system validation and most recent updates on electronic records and signatures (Part 11). We also offer a two day course for all aspects of compliance in analytical and QC laboratories. The courses are offered worldwide to all Pharmaceutical, Biopharmaceutical and medical device companies for in-house training, but also for institutes and seminar providers which are experienced in organizing and hosting any type of seminars, courses and conferences located anywhere in the world. Labcompliance courses differentiate from other courses and seminars through a lot of practical work, ranging from going through examples and case studies to collaborative workshops built into each training module. All courses are developed by Dr. Ludwig Huber, IVT's presenter of the year.

April 16, 2007

Update Annex 11: Using Computers in GMP

According to a concept paper published on the EMEA Annex 11 will be updated.. The current EC GMP Annex 11 has its origins in national guidelines dating from the early 1980s and over the subsequent years computerized systems and applications have evolved to such an extent that whilst the main principles of the guidance are still valid, the scope and content of the present annex are considered by experts in the area of computerized systems as no longer adequate to meet the needs of either the pharmaceutical industry or inspectors. In the concept paper the EMEA announces an Ad Hoc GMP Inspection Services Group to actively work on a revision of Annex 11. EMEA gives several recommendations to the group, one of them is looking how to capitalise on the output from the PIC/S Expert Circle on Computerised Systems, which has been considering these matters recently. The paper can be downloaded from the EMEA website.

April 16, 2007

"Failure to Check for Accuracy of Inputs to and Outputs from HPLC Instruments " Draws FDA Warning Letter

The Warning Letter was issued based on conditions found during an inspection conducted between July 10, 2006 and August 10, 2006. The letter states: "There was a failure to check for accuracy the inputs to and outputs from the Total Chrom Data Acquisition System, which is used to run your firm's HPLC instruments during analysis of drug products. For example, electronic data files were not routinely checked for accuracy and, as mentioned in the above observations, our investigators found numerous discrepancies between the electronic data files and documentation in laboratory notebook." In addition the company failed to record chromatographic raw data related OOS test results: "The chromatographic test data reflecting the out-of-specification test results were not recorded in laboratory notebooks. Instead, a new sample preparation was injected within the same chromatographic run without supervisory approval, as required by your firm's SOP". The Warning Letter can be downloaded from the Labcompliance Users Club. Non members can preview excerpts.

April 16, 2007

New EMEA Guidance for Herbal Medicines

The European Medicines Agency (EMEA) published the HMPC Guideline "Procedure for the Preparation of Community Monographs for Traditional Herbal Medicinal Products". The purpose of the document including its attachments is to streamline and enable consistent preparation of Community herbal monographs by the EMEA Committee on Herbal Medicinal Products (HMPC). The document can be downloaded from the EMEA Website

April 16, 2007

New USP Chapter <467> Residual Solvents Coming into Effect July 1, 2007

On July 1, 2007 the new USP-NF General Chapter <467> Residual Solvents comes into effect in final alignment with the ICH guideline. Main change is the adoption of Q3C in the general chapter of the USP while eliminating the OVI tests from the individual monographs. " All drug substances, excipients, and products are subject to relevant control of residual solvents, even when no test is specified in the individual monograph." The ICH guideline Q3C provides a consistent means of evaluating drug products to ensure patient safety. The analysis of residual solvents in pharmaceutical products and for solvents considered extractables/leachables in pharmaceutical packaging materials is typically done using a headspace (HS) gas chromatograph (GC) with flame-ionization detector (FID) or, for identification and confirmation, with mass-selective detection. Users of such systems currently face a number of problems: The area precision in HS analysis can be compromised primarily due to atmospheric pressure variations and the sensitivity is poor for some low-concentration analytes, e.g., benzene. Click here ┬┤to read how the problem can be solved with new technology and to get a free application notes.

April 16, 2007

FDA Warning Letter Issued for Inadequate Assessment of the Cross-contamination Risk

Buildings should be designed to avoid cross contaminations. The FDA expects to assess the risk of cross contamination during manufacturing and product testing. This became clear from a Warning Letter issued in January 2007: The letter states: "Your firm lacked an adequate assessment of the cross-contamination risks posed by the manufacture of several potent compounds (e.g. cytotoxic and hormone products, as well as other products of high pharmacologic activity) at your facility". The letter cited other deviations, for example: Failure to keep records for the maintenance, cleaning, and sanitizing of equipment and failure to establish sampling plans, test procedures, or laboratory control mechanisms for testing your finished product." he Warning Letter can be downloaded from the Labcompliance Users Club Non members can preview excerpts.

April 16, 2007

Google Search for Labcompliance

Labcompliance has added Google Search capability to it's Website. The search window is located in the navigation window of the LabCompliance entry screen. The search has two options:

  1. Search the Web. This is the standard Google search engine searching all Internet. Most readers will be familiar with this.
  2. Search the Labcompliance Website. This option limits the search to the 200+ free pages as published through LabCompliance. This helps to easily helps to find information on validation and compliance and makes your work more efficient.

Both options use the well known Google search conventions.