GLOBALLY HARMONISED

The Global Harmonisation Task Force (GHTF) was conceived in 1992 to address similar issues for medical devices. It has a broader regional base than its pharmaceutical counterparts in that it includes representatives from Canada and Australia in its core group, in addition to those from the EU, US and Japan. In some ways, it also faces a stiffer challenge in that there is more divergence in the regulatory... 

Supplementary requirements for specific types of drug products are contained in other Parts ofGhapters 9 and 21 of the Gode of Federal Regulations, as summarised in Table 11.1. IGH Q7 guideline provides globally harmonised principles ofGMP for APIs. 

Globally Harmonised Task force Guidance Quality Management Systems -... 

The Global Harmonised Scheme for Classification and Labelling of Chemicals... 

Fabian, A. C. Global harmonisation of GMPs for APIs. Pharm Tech (June 1999). FDA/ISPE. Baseline Pharm. Eng. Guide. Vol. 1, BPCs (June 1996). 

Australia intends to adopt the Globally Harmonised System (GHS), and the NOHSC is responsible for coordinating efforts in Australia in implementing the GHS. Thus the elements... 

The Globally Harmonised System for classification and labelling will be implemented in many countries over the next few years. 

The basis is the new EU regulation on classification (EC 2008), which implements the GHS (Globally Harmonised System of Classification and Labelling of Chemicals), see further in Bengtsson, this volume. 

Table 2.1 Hazard categories under the Globally Harmonised System [91]...

Figure 2.2 Pictograms for labelling hazardous chemicals [92] Reproduced with permission from Globally Harmonised System of Classification and Labelling of Chmeicals, UNECE. 2005, UNECE...

Developed, by a multidisciplinary team at the University of Cape Town, for the International Labour Office (ILO) Working Group on Hazard Communication as part of international efforts to promote a Global Harmonised System (GHS) for hazard communication. 

United Nations Globally Harmonised System 42 United Nations N.l test 53 Use descriptors 83... 

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