HPLC in FDA Warning Letters

Recommendation

Reference Standards - Live Online Training

Thursday, 3 September 2026 9 .00 - 17.00 h

Reference Standards - Live Online Training
Establishment, Use and Maintenance of Analytical Reference Substances

On the Road to 30,000 Members

Let us become the World's Leading GMP/GDP Compliance Community in 2026

Let us become the World's Leading GMP/GDP Compliance Community in 2026

In the current compilation of Warning Letters issued between 2009 and 2011 we have summarised for you the key points regarding the use of high performance liquid chromatography (HPLC).

The inspection focuses can be summarised and compiled in the following 4 themes:

  • Raw Data / Protection of Electronic Records
  • Calibration / Qualification
  • Method Validation
  • System Suitability / Sequences

All these topics and further important aspects of a GMP/FDA compliant use of HPLC in the GMP laboratory will be covered in detail and discussed in ECA's Education Course "Maximising HPLC Productivity" from 18 - 20 April 2012 in Prague. This event will be a great opportunity for you to prepare your HPLC lab for the next FDA inspection.

Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

Conference Recommendations

Reference Standards - Live Online Training


Thursday, 3 September 2026 9 .00 - 17.00 h

Reference Standards - Live Online TrainingEstablishment, Use and Maintenance of Analytical Reference Substances

EU GMP-/FDA-compliant Sampling - Live Online Training


22/23 September 2026

EU GMP-/FDA-compliant Sampling - Live Online Training

Ph. Eur., USP and other Pharmacopoeias - Live Online Training


6/7 October 2026

Ph. Eur., USP and other Pharmacopoeias - Live Online TrainingDealing with different compendial methods

Related GMP News

01.07.2026Several FDA Warning Letters and Untitled Letters on Asbestos Testing of Talc in OTC Drug Products

24.06.2026Analytical Quality Group Developments January through April 2026

17.06.2026BioPhorum Publishes a Roadmap for QC Sample Test Execution

03.06.2026EMA Provides an Outlook on the Product-Specific Bioequivalence Guidelines Expected in 2026

03.06.2026FDA Warning Letter: Missing Method Validation - From a QC Topic to a Market-Access Problem

28.05.2026WHO Working Document on Bioequivalence open for Public Consultation

Go back

NEWSLETTER

Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.