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PMPB/INS-GUIDE/02
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
...
discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
more
Medicines and Allied Substances [No. 3 of 2013 47 | An Act to continue the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority; provide for the functions and powers of the Authority; provide for the registration and regulation of pharmacie
...
s, health shops and agro-veterinary shops; provide for the registration and regulation of medicines and allied substances; provide for the regulation of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, advertising, sale and use of medicines and allied substances; provide for the regulation and control of clinical trials; repeal and replace the Pharmaceutical Act, 2004; and provide for matters connected with, or incidental to, the foregoing.
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Cet article fait partie d’une série d’explications à propos de la mise au point et de la distribution des vaccins.
a full range of completely free GxP training courses. They do not provide certificates but give you a quick and easy access to quality training resources wrapped in a pleasant, interactive and easy to digest form.
A.55 Medicines and Related Substances Act, 2013 | No. 8 of 2013 | An Act to provide for the registration, regulation of the sale, distribution, importation, exportation, manufacture and dispensing of medicines and related substances, and matters incidental thereto.
Ensuring Access to Simple, Safe and Effective First-Line Medicines for Tuberculosis.
Accessed in November 2017.
Prices people pay for medicines.
An Act to provide for the efficient and comprehensive regulation and control of food, drugs, medical devices, cosmetics, herbal drugs and poisons and to repeal the Food
(Control of Quality) Act, 1978, the Pharmaceuticals and Poisons Act, 1978 and to provide for related matters.
Long-lasting insecticidal nets (LNs) constitute a core vector control intervention against malaria. A number of new LN products are under development and will require assessment of risks to humans. This document provides an updated generic model that can be used for the risk assessment of exposure t
...
o insecticides of individuals sleeping under LNs and during the washing of nets.
In an Annex, exposures and health risks are described for the conventional treatment or retreatment of nets (ITNs) with an insecticide considering that such practices may still be used in evaluation of ITNs and their use. The generic model does not include the risks associated with the manufacturing of LNs in a factory environment. more
In an Annex, exposures and health risks are described for the conventional treatment or retreatment of nets (ITNs) with an insecticide considering that such practices may still be used in evaluation of ITNs and their use. The generic model does not include the risks associated with the manufacturing of LNs in a factory environment. more
WHO Regional Publications, Western Pacific Series No. 23
Reports the findings and recommendations of a working group convened to prepare guidelines for the use of herbal medicines in Western Pacific countries. Addressed to national health authorities, the report responds to the widespread use o ... f herbal medicine in this part of the world and the corresponding need for mechanisms to ensure that these products are safe and effective, yet remain broadly accessible. With this need in mind, the report sets out a comprehensive framework for developing national policies designed to control the safety, efficacy, and quality of herbal medicines, manufacturing practices, product registration, and labelling, marketing, and trade. more
Reports the findings and recommendations of a working group convened to prepare guidelines for the use of herbal medicines in Western Pacific countries. Addressed to national health authorities, the report responds to the widespread use o ... f herbal medicine in this part of the world and the corresponding need for mechanisms to ensure that these products are safe and effective, yet remain broadly accessible. With this need in mind, the report sets out a comprehensive framework for developing national policies designed to control the safety, efficacy, and quality of herbal medicines, manufacturing practices, product registration, and labelling, marketing, and trade. more
This document provides the specifications for major pesticide application equipment used for control of vectors of diseases. The specification guidelines contained herein are intended to assist national authorities and other public health users in selecting equipment of assured quality for applicati
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on of pesticides for vector control.
The test methods described herein are intended to assess whether the equipment will function for a minimum of three years with appropriate routine maintenance according to the manufacturer’s label instructions. Manufacturers shall be requested to provide warranty against manufacturing defects with guaranteed after-sales service on the equipment, any certification required by national authorities regarding materials used in the construction of the equipment, and results of tests that have been carried out for compliance with national or international specifications. more
The test methods described herein are intended to assess whether the equipment will function for a minimum of three years with appropriate routine maintenance according to the manufacturer’s label instructions. Manufacturers shall be requested to provide warranty against manufacturing defects with guaranteed after-sales service on the equipment, any certification required by national authorities regarding materials used in the construction of the equipment, and results of tests that have been carried out for compliance with national or international specifications. more
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