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Version 2.0 of eCTD – an upgrade over the original CTD – was finalized on February 12, 2002, [1] and version 3.0 was finalized on October 8 of the same year. [2] As of August 2016, the most current version is 3.2.2, released on July 16, 2008. [3] A Draft Implementation Guide (DIG) for version 4.0 of eCTD was released in August 2012. [4]
If they are above these levels the waste must be taken to a hazardous waste disposal facility and the cost of disposal may increase from about $50.00/ton to as much as $1200.00/ton. As extremely contaminated material is expensive to dispose of, grading is necessary to ensure safe disposal and to avoid paying for disposal of "clean fill."
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 minimum essential documents that are required for the registration of pharmaceutical products designed for human use are specified in the document 'ICH Good Clinical Practices,' published in 1997 by the ICH [2] Example ICH essential documents that would be required in any US, EU or Japan based clinical trial would include: signed protocol ...
The International Forecourt Standards Forum is a UK-based European organisation which designs standards for connecting devices on a service station forecourt, such as dispensers, Tank Level Gauges, Price Signs, Car Washes and Outdoor Payment Terminals. In recent years additional standards have been added for Electronic Funds Transfer.
On 24 February 1976, the treaty was signed into force by the leaders of the original members of ASEAN. [1] Other members acceded to it upon or before joining the bloc. It was amended on 15 December 1987 by a protocol to open the document for accession by states outside Southeast Asia, [2] and again on 25 July 1998, to condition such accession on the consent of all member states. [3]
The Bay of Bengal Initiative for Multi-Sectoral Technical and Economic Cooperation (BIMSTEC) is an international organisation of seven South Asian and Southeast Asian nations, housing 1.73 billion people and having a combined gross domestic product of US$5.2 trillion (2023).
Process performance qualification protocol is a component of process validation: process qualification. This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.