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Good Manufacturing Practices (GMPS)

Good Manufacturing Practices (GMPs) are guidelines issued by international organizations to ensure the highest standards of quality, efficacy and safety in manufacturing health products. GMPs govern production, distribution and supply of drugs and are required for marketing authorization. The article discusses the current state of GMP for medicines and emphasizes the importance of continuous updates, regulatory harmonization, adoption, and inspections to evolve quality assurance and safety through cooperation between national and international bodies.

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63 views2 pages

Good Manufacturing Practices (GMPS)

Good Manufacturing Practices (GMPs) are guidelines issued by international organizations to ensure the highest standards of quality, efficacy and safety in manufacturing health products. GMPs govern production, distribution and supply of drugs and are required for marketing authorization. The article discusses the current state of GMP for medicines and emphasizes the importance of continuous updates, regulatory harmonization, adoption, and inspections to evolve quality assurance and safety through cooperation between national and international bodies.

Uploaded by

RainMan75
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Good Manufacturing Practices (GMPs)

Good Manufacturing Practices (GMPs) are a compilation of various

guidelines/guidance documents/directives issued and elaborated by

international organizations and institutions, in collaboration with

Pharmaceutical Industry and several national regulatory authorities in

different regions and countries, in order to be guaranteed the highest

standards of efficacy, quality and safety in any process that involves the

manufacture of health products. GMPs are guidelines which govern the

production, distribution and supply of a drug. It is a necessary condition for

marketing authorization (MA). The aim of this review is to map the

regulation, production, distribution and consumption of pharmaceuticals.

It is intended to show and provide the General/Current State of GMP for

Medicinal Products for Human Use, emphasizing the importance of a

continuous update, regulatory harmonization, its adoption and

monitoring/inspection, in order to be able to achieve, through the greater

consensus, the continuous evolution of quality assurance, safety and

efficacy. This is possible through a close cooperation between the several

national and international entities, achieving a regulatory harmonization of

GMP for medicinal products for human use, as well as a more rigorous

monitoring compliance of these, by the competent authorities. Since the

middle of the beginning of the last half of the 20th century, all stakeholders
in the health and pharmaceutical industry are making efforts in the

conception, knowledge and applicability of guidelines for GMP. This article

is in line with the latest GMP guidelines for Medicinal Products for Human

Use, provided by the European Commission (EC), entitled Eudralex. The EC

directives were followed, making reference to the guidelines to GMP for

Medicinal Products for Human Use, where appropriate, which are available

by regulatory authorities, national and international organizations and

institutions such as US Food and Drug Administration (FDA), World Health

Organization (WHO), the International Conference on Harmonization of

Technical Requirements for Registration of Pharmaceuticals for Human Use

(ICH), and Pharmaceutical Inspection Co-Operation Scheme (PIC/S).

International Conference on Harmonization is an international organization

with the propose of making recommendations and implementing standards

of the International Organization for Standardization (ISO) to achieve

greater harmonization in the understanding and application of the guidelines

and technical requirements for registration of pharmaceutical products. This

organization is the only initiative that brings together the drug regulatory

authorities and the pharmaceutical industry in Europe, Japan and the United

States.

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