What is the difference between GMP and ISO

+ -What does DIN, EN, ISO actually mean? Click to collapse


 DIN = German industry standard
The Federal Republic of Germany has declared this norm to be the standard.

EN = European standard
The European Union has declared this norm as the standard for all member states.

ISO = International Standard Organization
The ISO is an organization in the USA that standardizes national and international norms with the same subject content.

+ - What is DIN ISO 9001? Click to collapse


DIN EN ISO 9001 is a standard for a quality management system that is recognized worldwide. To date, 130 countries have accepted this norm as the standard.
 
It applies to industries related to the design, development, manufacture, installation and maintenance of products or services. The standard applies to all industries and companies of all sizes.

It supports companies in introducing and working with QM systems. For this purpose, the basics of QM systems are explained and terms of quality management are defined and explained.

With the help of this standard, the user receives the content and conceptual knowledge to safely use DIN EN ISO 9001: 2008. This set of standards is based on a process-oriented structure and can be used for all companies.

+ - What does GMP, GLP, GCP mean? Click to collapse

The GxP quality systems are used in the development, manufacture, storage and distribution of products in the pharmaceutical, food, chemical, cosmetics and biotech sectors.

GMP = Good Manufacturing Practices
is a set of rules to ensure proper manufacture. The guidelines concern: safeguarding all work processes, avoiding mix-ups, avoiding contamination, production hygiene, quality control, documentation of production and control.

cGMP = Current Good Manufacturing Practices
US GMP rules, which are revised annually (always in April) and adapted to the latest state of knowledge (therefore "current").

GLP = Good Laboratory Practices
Principles and guidelines for planning, carrying out and evaluating experimental studies of substances are summarized in the GLP. The procedure defines standards for: organization and personnel, premises, work instructions, result reports as well as for archiving and retention periods.

GCP = Good Clinical Practices
Principles and guidelines for planning, conducting and evaluating clinical studies with medicinal products on humans

+ - What do the colors mean in biotechnology? Click to collapse



"Blue" biotechnology:
Development and application of biotechnology using marine resources.

"Green" biotechnology:
Plant and food biotechnology.

"Gray" biotechnology:

Development and application of bioprocess engineering in industry and in environmental protection.

"Red" biotechnology:

Human, veterinary and pharmaceutical development and applications of biotechnology.

"White" biotechnology:

Ecological optimization of biotechnology-based products and industrial processes, for example in the chemical, textile or food industries.

+ - What does life science mean? Click to collapse


An Anglo-American borrowing of words that could literally be translated as "life sciences" is ultimately a collective term for scientific and technical disciplines such as biochemistry and biotechnology, which investigate life processes but at the same time try to control them (e.g. through genetic manipulation).



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