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

Related Conference of Purpose and Principles of GMP

December 02-03, 2020

2nd International Conference on Bio-Pharmaceuticals

Auckland, Newzealand
December 07-08, 2020

International Conference on Biotechnology and Healthcare

Auckland, Newzealand
December 16-16, 2020

21st World Conference on Pharmaceutical Chemistry and Drug Design

Singapore City, Singapore
December 16-16, 2020

22nd World Congress on Pharmacology, Nursing and Healthcare

Algeria, Algeria
January 22-23, 2021

1 st Global Summit on Generic Drugs and Quality Control

Prague, Czech Republic
January 22-23, 2021

1 st World Congress on Rare Diseases & Orphan Drugs

Prague, Czech Republic
February 26-27, 2021

2nd Annual Congress on Antibiotics and Bacterial Infections

Geneva, Switzerland
March 10-11, 2021

6th Pharmaceutical Chemistry Conference

Paris, France
March 16-17, 2021

14th Global Pharmacovigilance And Clinical Trials Summit

Albufeira, Portugal
April 11-12, 2021

2 nd World Pharma Expo

Tokyo, Japan
April 12-13, 2021

2nd International Conference on Biosimilars & Pharmaceuticals

Auckland, Newzealand
April 28-29, 2021

31st Annual European Pharma Congress

London, UK
April 28-29, 2021

14th European Biosimilars Congress

London, UK
May 10-11, 2021

20th Annual Meet on Pharmaceutical Sciences

Yokohama, Japan
May 17-18, 2021

8th European Biopharma Congress

Prague, Czech Republic
May 19-20, 2021

36th World Pharmacology and Therapeutics Forum

Singapore, Singapore
June 07-08, 2021

2rd European Conference on Pharmacovigilance and Drug Safety

Prague, Czech Republic
July 10-11, 2021

2 nd Pharma Expo China

Tokyo, Japan
August 16-17, 2021

Global summit on Cosmetic & Reconstructive Surgery

Tokyo, Japan
August 16-17, 2021

34rd World Congress on Pharmacology

London, UK
October 29-30, 2021

14th World Drug Delivery Summit

Vancouver, Canada
October 29-30, 2021

12th Annual Biomarkers and Clinical Research Congress

Vancouver, Canada

Purpose and Principles of GMP Conference Speakers

Recommended Sessions

Related Journals

Are you interested in