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The Qualified Person in the Pharmaceutical Industry

Understanding Qualification Requirements, Tasks, Duties and Responsibilities

 April 15, 2010


Documentation for FDA and EU Compliance

Step-by-step Instructions with Sample Documents

March 25, 2010


Qualification and Calibration of Stability Chambers
Learn how to select, conduct and document the right test parameters and conditions

March 31, 2010


New  release on
August 25, 2009 

with 200 + eirs/483sb / warning letters



Labcompliance News, February 2010

FDA Launches a new Risk-Assessment Tool for Better Drug and Food Import Control

On February 4, 2010, Commissioner Hamburg announced the launch of a new risk-assessment tool to ensure the safety of imported food and drugs. The web-based PREDICT system will rank the risk hazards of food and drugs as they enter the country and allow inspectors to focus on the most likely threats to public health. PREDICT will assist entry reviewers in targeting higher-risk shipments for examination. It will also expedite the clearance of lower-risk cargo, but only if accurate and complete data are provided by importers and entry filers. To see FDA's press release, click here.

ICP Systems for Metal Impurity Analysis Must be Part 11 Compliant

USP has proposed several standards for analysis of metal impurities in raw material, drugs and food. ICP-MS and ICP-AES are recommended as analytical techniques. These are computerized systems that should comply with Part 11. This became obvious from an FDA warning letter. The letter states: "The computer software your firm uses to determine metals analysis is deficient. It has no security measures to prevent unauthorized access of the software, no audit trails, and data can be copied or changed at will, with no documentation of the copying or changes". FDA also makes it clear that users of such systems should be trained: "There is no documentation to indicate that analysts are trained in the software and its applications". Furthermore, the company was cited for not documenting computerized raw data, and for repeat testing of OOS products without first conducting an investigation. The Warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-058.  Learn more about analysis of metal impurities according to the proposed USP standard in the Labcompliance audio seminar.

USP Changes Dissolution Performance Verification Tests

Since Dec 1, 2009, the Performance Verification test (PVT) using Salicil acid Tablets RS is no longer required for USP apparatus 1 and 2. The tests using the Prednisone Tablets RS tablets for USP Apparatus 1 and 2 and Chlorpheneramine Maleate Extended-Release Tablets RS for USP Apparatus 3 are still required. Also beginning December 1, 2009, the change in General Chapter <711> removing the requirement for individual tablet tests for the PVT became official. This is not a change in the PVT procedure or criteria. The chapter will instead rely on the Technical Data Sheet provided with the particular lot of RS to provide the acceptance criteria. This change to <711> allows USP, via the Technical Data Sheet, to move from acceptance criteria for the individual tablet results to a new set of criteria at a later date, .

"OOS of Stability Chambers not Investigated" Draws FDA Warning Letter

The temperature and humidity of stability chambers need to be well controlled. Deviations from accepted limits should be investigated. FDA cited a pharmaceutical company in New Jersey for not investigation an OOS situation: "Out-of-specification (OOS) humidity levels for the controlled room temperature stability chamber were noted on January 27, March 17, and April 5 and 6, 2009. Investigations and corrective actions were not conducted at the time to address these out-of-specification results". Other deviation included: 'Variation in the amount of components for preparation of dosage forms not justified and documented' and 'Stability indicating test methods not followed'. The Warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-229.  Learn more about analysis of metal impurities according to the proposed USP standard in the Labcompliance audio seminar

FDA Publishes New Guidance for Calibration of Dissolution Apparatus 

This guidance is intended to aid drug manufacturers in calibrating U. S. Pharmacopeia (USP) Dissolution Apparatus 1 and 2 to help assure that critical parameters associated with the dissolution apparatus meet certain mechanical calibration (MC) tolerances. This guidance recommends that an enhanced MC procedure can be used as an alternative to the current Apparatus Suitability procedure for Dissolution Apparatus 1 and 2 described in USP General Chapter <711> Dissolution.. To download the guidance, click here.

FDA Warning for Data Manipulation

During a recent inspection of an API manufacturer inspectors uncovered manipulation of quality control test records. Computerized printed IR spectra have been manipulated by the analyst, most likely to bring an OOS result into specification: "Your firm's laboratory analyst had modified printed raw data related to the IR Spectra test of (b)(4) and (b)(4). We are concerned that the lack of security or system controls allows for this practice."  Furthermore the company was cited for the Quality Control Unit not being able to detect the manipulation. The Warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-230.  Even though Part 11 has not been mentioned this is just an other example how the FDA enforces Part 11. To learn everything about FDA's new Part 11 strategy and enforcement practices, attend the Labcompliance audio seminar "FDA's New Enforcement of Part 11".

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: Subcontracting of Test and Calibration. To download your free copy, go to the ISO 17025 Accreditation Package website.  Scroll down and click on the corresponding ICON on the left (offer expires on February 20, 2010). Labcompliance offers more than 100 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

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