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The manufacturing process is one of the key steps where quality control is required to ensure quality of medicinal products, including herbal medicines. Good manufacturing practices (GMP) is one of the most important tools for this measure.
In preparing this paper, the Pharmacovigilance Group of the Pan American Health Organization’s Pan American Network for Drug Regulatory Harmonization (PANDRH) adopted the perspective of PAHO/WHO, which considers Pharmacovigilance, an essential component of public health programs. Its intention was...
WHO Technical Report Series, No. 908, 2003, Annex 9. This guide is intended for those involved in the storage, transportation and distribution of pharmaceuticals. It describes the special measures considered appropriate for the storage and transportation of pharmaceuticals.
Doc. No.: INS/GDL/001-(Annexes)
Drug Advisory Board
14.04.2016
Pharm -Ed
--
The alcohol-based solution for hand hygiene is now part of the WHO essential medicines list .Local production of the alcohol-based handrub is an alternative to commercial products. Although adapted to contexts with limited resources, it is essential to respect the Good Man...
Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,...
Guidelines for the production of extemporaenous formulations and hospital based sterile preparations
In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...
Recommendations for step-wise implementation
Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, ensure that medicines and related substances are of high quality, safety and efficacy. SAHPRA is a
participating authority of the Pharmaceutical Inspection Cooperation Scheme (jointly known as PIC/S)...
This manual has been prepared by the Group on Agriculture of the FAO Regional Office for Latin America and the Caribbean. The purpose of this work is to spread the basic concepts of Good Agricultural Practices (GAP)in order to: guide the production systems towards a sustainable agriculture and ecolo...
The Virtual cGMP Training Marathon for Vaccine Manufacturing: Principles into Practice took place from 12 Sep to 10 Oct 2023 to continue to provide manufacturers & regulators with a comprehensive array of topics to build understanding of current WHO & international GMP standards, technological advan...
