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[1] [2] The initial members comprised the 10 member countries of EFTA at that time. In the early 1990s it was realized that because of an incompatibility between the Convention and European law, it was not possible for new countries to be admitted as members of PIC. European law did not permit individual EU countries that were members of PIC to ...
Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use. Many countries have legislated that manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
GAMP published its first guidance in 1994. Soon afterwards the organization entered into a partnership with ISPE, formally becoming part of ISPE in 2000. GAMP has enjoyed the support of numerous regulatory authorities over the years spanning the United States, Europe, and Japan and is now a recognised good practice worldwide. [5]
The database serves as a quick reference for checking the good manufacturing practice (GMP) of a potential contract manufacturer. One can search by the “company name, location, or certificate number and find details on the types of products or activities that the company conducts and the date of the most recent GMP inspection.” [ 3 ]
The dominant customary international law standard of statehood is the declarative theory of statehood, which was codified by the Montevideo Convention of 1933. The Convention defines the state as a person of international law if it "possess[es] the following qualifications: (a) a permanent population; (b) a defined territory; (c) government; and (d) a capacity to enter into relations with the ...
List of terms for country subdivisions; List of national capitals serving as administrative divisions; List of autonomous areas by country; List of sovereign states; List of political and geographic subdivisions by total area, comparing continents, countries, and first-level administrative country subdivisions. List of first-level ...
ASEAN: the Association of Southeast Asian Nations, a regional organisation comprising ten Southeast Asian states; ASEAN+3: the ASEAN countries, plus China, Japan, and the Republic of Korea (South Korea). [4] ASEAN+5: the ASEAN countries with Japan, India, Australia, South Korea and New Zealand. ASEAN+6 along with China. [5] [6] [7] [8]