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The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. [1] [2] The initial members comprised the 10 member countries of EFTA at that time.
The goals of a change control procedure usually include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing change. According to the Project Management Institute , change control is a "process whereby modifications to documents, deliverables, or baselines ...
Ethiopia is the second most populous country in sub-Saharan Africa, with a population of over 120 million people. As of the end of 2003, the United Nations (UN) reported that 4.4% of adults were infected with human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS); other estimates of the rate of infection ranged from a low of 7% to a high of 18%.
STORY: "The situation in Ethiopia is spiraling out of control. Violence and destruction have reached alarming levels," Guterres told reporters. "Hostilities in the Tigray degrade region of ...
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
The Ministry of Health (MoH) (Amharic: ጤና ሚኒስቴር) is the Ethiopian government department responsible for public health concerns. Its head office is on Sudan Street in Addis Ababa. [2] Mekdes Daba has been the head of the ministry since February 2024. The organization is a cabinet level organization which has authority over the ...