cGMP Guidelines

cGMP Guidelines

Find out more about the current Good Manufacturing Practices, and regulations set forth by the U.S.
Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Sciences Authority (HSA), International Council for Harmonisation (ICH), Standards Coordinating Body (SCB), Alliance for Regenerative Medicines (ARM), Therapeutics Goods Administration (TGA), Pharmaceuticals and Medical Device Agency (PMDA) and Pharmaceutical Inspection Co-operation Scheme (PIC/S) in this
section.

It contains minimum requirements for the methods, facilities, and controls used in
manufacturing and processing.

 

Below are the links:

U.S. Food and Drug Administration (FDA)

https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/cellular-gene-therapy-guidances

European Medicines Agency (EMA)

https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/multidisciplinary/multidisciplinary-cell-therapy-tissue-engineering

Health Sciences Authority (HSA)

https://www.hsa.gov.sg/ctgtp/regulatory-overview

International Council for Harmonisation (ICH)

https://www.ich.org/page/ich-guidelines

Standards Coordinating Body (SCB)

https://www.standardscoordinatingbody.org/guidance-regulations

Alliance for Regenerative Medicines (ARM)

https://alliancerm.org/

Therapeutics Goods Administration (TGA)

https://www.tga.gov.au/publication/australian-regulatory-guidelines-biologicals-argb

Pharmaceuticals and Medical Device Agency (PMDA)

https://www.pmda.go.jp/english/pnavi_e-08.html

Pharmaceutical Inspection Co-operation Scheme  (PIC/S)

https://picscheme.org/en/publications?tri=gmp#zone