What is GxP?

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What is gxp?

 

GxP is an acronym for “Good x Practices”, with the “x” being interchangeable for use in multiple industries such as pharmaceutical, medical device, food, etc.  In the pharmaceutical and medical device industries, common terms utilized are GMP (Good Manufacturing Practices), GCP (Good Clinical Practices), and GLP (Good Laboratory Practices).  These terms refer to a collection of quality assurance practices that ensure a company’s products are compliant to regulations, meet their intended use, and are safe.

Agencies such as the FDA (US Food and Drug Administration) set forth guidelines like the 21 CFR with requirements that industries must follow to be able to sell products.  For pharmaceutical drugs, these guidelines ensure the product’s SQIPP.  SQIPP is an acronym that stands for Safe, of good Quality, have the correct Identity, are Pure, and are Potent.  GxP practices, if followed correctly, make sure that SQIPP is achieved.   

At H&A Scientific, we also follow GxP to ensure that our products are suitable for use in these highly regulated industries and are compliant with the FDA’s 21 CFR Part 11, which establishes requirements for computer systems.  Have questions about GxP or it’s use by H&A Scientific? Ask us today!

STABILITY LABORATORY DATABASE MANAGER

Commercial off-the-shelf solution for complete management of your drug stability program.

INTUITIVE SHELF-LIFE PROJECTION SOFTWARE

Developed specifically to determine the shelf-life of drug products placed on stability.

VALIDATED & CUSTOMIZABLE REPORT GENERATION

Seamless generation of validated stability reports in a format ready for FDA submission.

DEDICATED TO CONTINUOUS IMPROVEMENT

Designed to maintain compliance with requirements of the FDA and GAMP.