USP Chapters <232> and <233> for Elemental Impurities Final

USP is releasing the final chapters for elemental impurities on February 1. While chapter <232> defines elements and limits chapter <233> describes test equipment and procedures. The current chapter <231> is still active until April 2014 but according to an USP General Notices release will be obsolete by May 1, 2014. This means all monographs with requirements for heavy metal testing will have to follow the new USP chapters. Details about this process can be found on the USP website. To learn everything about requirements for elemental impurities attend the new audio seminar: "Elemental Impurities According to the Final USP Chapters 232/233" 

FDA Expects Periodic Requalification of GCs and HPLCs

This became obvious in a recent FDA inspection of a testing laboratory followed by a warning letter. The warning letter reads: Your firm has failed to calibrate instruments and recording devices at suitable intervals in accordance with an established written program containing specific directions, schedules, limits for accuracy and precision, and provisions for remedial action in the event accuracy and/or precision limits are not met [21 C.F.R. § 211.160(b)(4)].For example,

• Your firm does not have an established written program to calibrate/qualify the xxx gas chromatograph (GC) at suitable intervals.
• Your firm did not calibrate and qualify the xxx high performance liquid chromatography (HPLC) instrumentation adequately, in that there is no periodic qualification or evaluation of the pump, oven, injector, or detector.

The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-278.  To learn everything how to qualify and re-qualify analytical equipment attend the audio seminar  "Laboratory Equipment Qualification according to USP <1058>" The seminar suggests extent and frequency of periodic requalification.

FDA Presentation on Quality by Design for Analytical Methods Available

The topic has been presented by Yubing Tang, PhD, from the FDA/CDER.  After an overview of QbD Dr Tang talked about the role of analytical methods under QbD approach and the benefits of QbD for the industry. Most interesting was the part on 'Regulatory considerations of the QbD approach for analytical methods'. In the concluding remarks Dr. Tang encouraged applicants to discuss ‘novel’ QbD implementation approaches with the agency prior to submission . The presentation  is available for members of the Labcompliance Usersclub and for attendees of the upcoming Labcompliance audio seminar "Quality by Design (QbD) for Development and Validation of Analytical Methods".

FDA Warning Letter for Insufficient  Training and inadequate Response

Inadequate training continues to be one of the top citations in FDA warning letters. This became obvious in a new warning letter from December 2012. In this example laboratory personnel did not follow procedures to comply with GMP requirements due to insufficient training. The letter reads: "Your firm failed to ensure that each person has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions. Personnel were not following the procedures that govern their activities, such as glove change frequency, the handling of dropped objects, personnel monitoring, and sample acquisition." Even though the drug manufacturer responded that the personnel has been retrained, the response was not acceptable because no root cause analysis has been made to find out why the original training was not successful: "Your response did not provide an explanation for why your (training) system was unable to recognize, identify and mitigate these performance lapses".  The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-279.  To learn how to conduct, verify effectiveness and document trainings  attend the audio seminar  "Effective Training Practices for FDA and International Compliance". The training reference material includes several examples of training related FDA warning letters, root cause analyses and corrective and preventive action plans.  

FDA Expects Multifold Increase of Foreign Generic Drug Manufacturer Inspections

New user fees through the Generic Drug User Fee Amendments (GDFUFA) as part of the new Food and Drug Administration Safety and Innovation Act will enable FDA to substantially increase the frequency of foreign inspections to every 2 years. Manufacturers of  biosimilar and generic drugs will be assessed an annual establishment fee equal to the establishment fees paid for proprietary drug product establishments.  Currently, FDA only has resources to conduct inspections of foreign generic drug manufacturers  once every 7 to 13 years. For more information read the related FDA fact sheet. To learn everything about FDA's new inspection and enforcement practices register for the Labcompliance audio seminar,

NATA Updates Technical Note for the Validation of Test Methods

Method validation and verification are essential requirements of accreditation to ISO/IEC 17025 and ISO 15189. Accordingly, facilities accredited to these Standards must demonstrate the validity of all methods used by validating all in-house and modified standard methods and verifying standard methods. This 33-page Technical Note published by the Australian National Association of Testing Authorities (NATA) describes the aspects of a method that should be considered when undertaking method validation or method verification, and provides guidance on how they may be investigated and evaluated. The guidance is available for free from the NATA website.

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 Best Practice Document "SOP: Handling Out-of-Specification Results". To download your free copy, go to the Laboratory Compliance Package website. Scroll down and click on the corresponding ICON on the left (offer expires on February 10 , 2013). Labcompliance offers more than 150 SOPs and other documents that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

IVT’s 3rd´Validation Week Singapore

The Pan Pacific’s Most Comprehensive Event Dedicated to Validation
February 25-26, 2013
Pan Pacific Hotel, Singapore

With Dr. Ludwig Huber as keynote speaker