Towards one world-wide harmonized manufacturing practice standard for drug substances and drug products?
- At: 2005 FIP Congress in Cairo (Egypt)
- Type: Presentation
- By: SAM, Tom (NV Organon, Regulatory Affairs, Oss, Netherlands)
Essentially similar GMP standards should apply world-wide, since API manufacturers and pharmaceutical companies have to assure the quality of their products independent of the place of manufacture or the location of the patient. Despite recent attempts to harmonize GMPs, the current standards for manufacturing practice differ for the various.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.