Guidelines for Good Manufacturing, Laboratory and Clinical Practices (GMP, GLP, GCP)

a.    Who Good Manufacturing Practices (GMP)

Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. 

GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labelling.

Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.

b.   Good Laboratory Practices (GLP)

GLP specifically refers to a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) safety and efficacy tests. GLP was instituted following cases of animal test fraud by pharmaceutical and industrial chemical (mainly pesticide) manufacturers.

c.    Good Clinical Practices (GCP)

Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation (ICH) that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.

Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds.

d.   International Organisation for Standardization (ISO)

The International Organization for Standardization, widely known as ISO, is an international standard-setting body composed of representatives from various national standards organizations. 

While ISO defines itself as a non-governmental organization, its ability to set standards that often become law, either through treaties or national standards, makes it more powerful than most non-governmental organizations.