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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.
Pharmaceutical policy is a branch of health policy that deals with the development, provision and use of medications within a health care system. It embraces drugs (both brand name and generic), biologics (products derived from living sources, as opposed to chemical compositions), vaccines and natural health products .
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 ...
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 ...
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%.
Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested ...
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 ...