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.
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European Journal of Biomedical and Pharmaceutical Sciences, vol.3 (2016) 1, 192-206
This review shows that if all sub areas of pharmaceutical waste management can efficiently work back to back environmental pollution and dangers to human health can reduce significantly.
Global UNIDO Project: Strengthening the local production of essential medicines in least developed and developing countries
The availability of controlled medicines is crucial for patients requiring palliative care, pain relief and symptom management. Many individuals worldwide, especially in low- and middle-income countries, continue to experience limited access to these essential medicines. Enhancing access to controll...ed medicines is paramount in promoting universal health coverage. This report offers a detailed situational analysis of policies and programmes aimed at improving access to affordable, high-quality controlled medicines for pain management in the WHO South-East Asia Region. The report identifies the existing barriers, challenges and possible solutions to facilitate access to such medicines across all Member States.
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First Revised Edition
March 2000
The strategic framework gives guidance to public and private health facilities and health workers on compliance with standards relating to IPC practices. To further assist health facilities to implement the IPC strategic framework, this practical implementation manual has been developed in parallel ...to accompany the document.
These implementation strategies should be read in conjunction with the National Infection Prevention and Control (IPC) Strategic Framework (2020) to support an IPC programme at health facility level towards reducing healthcare-associated infections (HAI) and antimicrobial resistance (AMR). This manual is aligned with the World Health Organization (WHO) Core Component IPC programme recommendations and highlights the essentials for developing and improving IPC at health facility level in a systematic, stepwise manner for South Africa. It supports the Framework for the Prevention and Containment of AMR in South African Hospitals (2018).
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Antimicrobial resistance (AMR) is a global threat that requires urgent collaborative action within and among countries. AMR makes standard treatments ineffective and facilitates the spread of antimicrobial resistant infections rendering communities vulnerable. The Ministry of Health (MOH) and Minist...ry of Agriculture, Livestock, Fisheries & Blue Economy (MALF) recognized antimicrobial resistance as a priority following findings from status reports and studies from Ministries, Departments, Agencies and Stakeholders.
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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).... PIC/S aims to develop international standards between countries and pharmaceutical inspection
authorities, to provide harmonised and constructive co-operation in the field of GMP. PIC/S affiliation is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent legislation, regulatory and enforcement procedures and inspection capacity.
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Document No. : FDA/SMC/SMD/GL-RAR/2013/01
Therapeutics Information and Pharmacovigilance Centre | TIPC
Made under Section 5 (c) of the Tanzania Food, Drugs and Cosmetics Act, 2003 | Second Edition