Purpose and Principles of GMP

Pharmaceutical quality affects every American. FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMPs) regulation for human pharmaceuticals. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of CGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of CGMPs. This paper discusses some facts that may be helpful in understanding how CGMPs establish the foundation for drug product quality.

The worldwide market for biosimilars came to $1.7 billion in 2010 and $2.5 billion in 2011. The market is relied upon to reach $3.6 billion by 2016, a compound yearly development rate (CAGR) of 7.7%.

 

  • Facts About Current Good Manufacturing Practices (cGMPs)
  • Good Automated Manufacturing Practice (GAMP)
  • FDA Good Manufacturing Practices
  • GMP Requirements & Standards

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