FDA compliant HPLC qualification and performance testing

FDA compliant HPLC qualification and performance testing is an important element of chromatographic test methods. Chromatographic test methods are used in a number of clinical applications.  The most common uses of chromatographic methods are in the quantitative and qualitative analysis of raw materials, drug substances, drug products and compounds in biological fluids. HPLC or High Performance Liquid Chromatography is obtained by the interaction and differential partition of the sample between the mobile liquid phase and the stationary phase.

Since HPLC forms an important aspect of pharmaceuticals, it needs to be validated. FDA compliant HPLC qualification and performance testing is the process of testing the reliability, reproducibility and predictability of HPLC qualification and performance in accordance with compliance standards set out by the FDA.

How to carry out FDA compliant HPLC qualification and performance testing?

When a pharmaceutical organization has to carry out an FDA compliant HPLC qualification and performance testing; it has to satisfy the test in relation to these among other important criteria:

  • Accuracy
  • Detection and quantitation limits
  • Linearity
  • Precision

Consequences an FDA compliant HPLC qualification and performance testing

One of the most important consequences of a pharmaceutical organization not having an FDA compliant HPLC qualification and performance testing is that it invites a Warning Letter and a 483 citation from the FDA. These citations can attract fines and penalties, apart from adversely impact the organization’s quality standards and reputation.

Reference:

http://www.fda.gov/downloads/Drugs/Guidances/UCM134409.pdf

 

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s