(1997; 248 pages) [French]
Part Six. Studies needed to support new post-marketing manufacturing conditions
With all pharmaceutical products, when post-marketing changes are made, extensive in vitro and/or in vivo testing may be required. Such changes may be in: (i) formulation; (ii) site of manufacture; (iii) manufacturing process; and (iv) manufacturing equipment. The types and extent of the further testing required will depend on the magnitude of the changes made. If a major change is made, the product might then become a new pharmaceutical product, if the national regulatory authorities so decide.