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Last revised 2015.
Original Word document on: http://www.epnetwork.org/Resources/Standard%20Operating%20Procedure/Temperature%20chart_Form.doc
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,...
The manufacturing process is one of the key steps where quality control is required to ensure quality of medicinal products, including herbal medicines...
Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically ...
This manual is designed primarily to assist managers of national malaria programmes and national reference laboratory responsible for quality assurance of malaria microscopy control. The information...
The prevalence, availability, and use of antimalarial medicines (AMLs) were studied in six Cambodian provinces along the Thai-Cambodian border. The study was divided into two parts: the first looked at the ... of AMLs available in Pursat, Pailin, Battambang, Bantey Meanchey, Oddar Meanchey, and Preah Vihear and the second obtained information about the availability and use of AMLs.
This guideline aims to improve the quality of donations and the management thereof and serve as the basis for policies of the State and other organizations in the giving and receiving of donations of medic..., medical devices and IVDs.
Over the last three or four decades, there has been an enormous increase in scientific knowledge about the mode of action, effects and side effects of medicines, medical devices and IVDs. It is important for all
stakeholders to understand that these products have both benefits and risks, that they have to be used carefully and appropriately and that some can do more harm than good.
There are many different scenarios for the donation of medicines, medical devices and IVDs. Donations may take place in acute emergencies or as part of development aid in non-emergency situations. They may involve donations (i.e. direct or through private voluntary organizations), aid by governments or persons authorized to sell medicines, medical devices and/or IVDs.
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking...
The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability and accessibility of ... medicines for the population. To fulfill its mandate, DPMED aims to strengthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system
This guidance should be followed if an unlicensed medicine is prepared in
a registered pharmacy. The preparation of an unlicensed medicine (for
example unlicensed methadone, or menthol in aqueous cream) in a pharmacy is called ‘extemporaneous preparation’.
The guidance should be read alon...
WHO Technical Report Series, No. 961, 2011, Annex 8 - These guidelines are intended to provide a description of ways in which pharmacists can improve access to health care, health promotion and the use of medicines on behalf of the patients they ser...
Procurement and supply management activities are fundamental to consistent and reliable access to essential medicines and health products. To reduce the impact of CVD, action needs to be taken to improve prevention, diagnosis, care and management of...
This standard Operating procedure (SOP) for JDWNRH is intended to describe and
address various important areas like admission procedure, on call process of the
doctors, interdepartmental consultation, patient discharge process and verity of
other areas which was so far solely based on verbal i...
The MSF qualification scheme is concerned with the pharmaceutical quality assessment for drugs. This procedure is applicable to products for international supply, i.e. products supplied through the MSF procurement centres. This qualification procedu...
SOP- Quality Assurance of Malaria Diagnostic Tests
Session V: Regulatory & quality assurance aspects
Update on prequalification of ARVs and regional harmonisation of medicine registration
Deusdedit K. Mubangizi
Group Lead, Inspections, WHO-PQT ...
These guidelines for the National Pharmacovigilance and Medicine Information System in Rwanda have been developed to ensure that safe, efficacious and quality medicines are made available to all Rwa...
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...
Types of radiotherapy equipment covered by the guide include external beam radiotherapy machines (both Cobalt-60 and linear accelerators), brachytherapy devices that apply radiation sources directly to tumours and complementary imaging devices such as conventional or computed tomography (CT) simulat...
