Article | REF: TE7504 V2

International Regulation and Standardisation in bodies of e-Health equipments

Author: Daniel BATTU

Publication date: February 10, 2020

You do not have access to this resource.
Click here to request your free trial access!

Already subscribed? Log in!


Français

7. Drug standards and regulations

7.1 In the world

To guarantee the potency and purity of active ingredients, as well as the quality of finished products, the manufacture of pharmaceutical products must comply with strict standards. These standards, drawn up after worldwide consultation with several qualified bodies including ISO, USP (United States of Pharmacopeia), ASTM (American Society for Testing and Materials), NIST (National Institute of Standards and Technology), etc., guarantee safe and effective products. WHO defined its own GMPs (Good Manufacturing Practices) in 1967, based on the "Current Good Manufacturing Practices" already in use in the USA since 1963. In this respect, the WHO recommends that regulatory requirements be based on compliance with good practices for controlling the quality, safety and...

You do not have access to this resource.

Exclusive to subscribers. 97% yet to be discovered!

You do not have access to this resource.
Click here to request your free trial access!

Already subscribed? Log in!


The Ultimate Scientific and Technical Reference

A Comprehensive Knowledge Base, with over 1,200 authors and 100 scientific advisors
+ More than 10,000 articles and 1,000 how-to sheets, over 800 new or updated articles every year
From design to prototyping, right through to industrialization, the reference for securing the development of your industrial projects

This article is included in

Technological innovations

This offer includes:

Knowledge Base

Updated and enriched with articles validated by our scientific committees

Services

A set of exclusive tools to complement the resources

Practical Path

Operational and didactic, to guarantee the acquisition of transversal skills

Doc & Quiz

Interactive articles with quizzes, for constructive reading

Subscribe now!

Ongoing reading
Drug standards and regulations
Outline