proposed amendment to the food and drug regulations 1447 good manufacturing practices 7 pages available in english and french the good manufacturing practices regulations division 2 of part c of the food and drug regulations the regulations are reviewed by health canada every three years. as a result several provisions have been identified for amendment because they are not consistent with international standards and or current industry practice are not uniformly applied to all sectors of the industry or do not provide the requisite regulatory support to current health canada interpretations. the purpose of this regulatory proposal is twofold to align the regulations with international standards and to codify existing health canada regulatory interpretations. other provisions also require amendment to correct minor errors. a listing of the issues noted in the regulatory proposal appears below. a description of the quality control requirements follows quality control requirements premises reworking complaints on quality samples medical gases background on quality control requirements under the current regulations the requirements related to the quality control department apply only to fabricators packagers labellers distributors and importers. wholesalers are not required to have a quality control department. however wholesalers play an important role in the pharmaceutical industry through the wholesale selling of drugs regulated under the food and drugs act and therefore have an effect upon the safety quality and efficacy of drugs in canada. furthermore the current health canada interpretation for personnel sets out the training and experience required of the head of the quality control department of a wholesaler. therefore in recognition of the role wholesalers play and to provide consistency of the regulations with the interpretation of c.02.006 health canada is amending c.02.013 1 of the regulations to require wholesalers to have a quality control department on their premises supervised by personnel referred to in c.02.006. under this amendment health canada will require that the head of the quality control department of a wholesaler also approve a returned drug for further sale under c.02.014 2 as is the case in the quality control departments of fabricators packagers labellers and distributors.