Food and Drug Regulations (C.R.C., c. 870)

Regulations are current to 2013-06-10 and last amended on 2013-05-31. Previous Versions

Division 2

Good Manufacturing Practices

C.02.001. [Repealed, SOR/97-12, s. 5.1]

C.02.002. In this Division,

“drug”

“drug”[Repealed, SOR/97-12, s. 6]

“importer”

“importer”[Repealed, SOR/97-12, s. 6]

“medical gas”

“medical gas” means any gas or mixture of gases manufactured, sold or represented for use as a drug; (gaz médical)

“packaging material”

“packaging material” includes a label; (matériel d’emballage)

“produce”

“produce”[Repealed, SOR/97-12, s. 6]

“quality control department”

“quality control department”[Repealed, SOR/2010-95, s. 1]

“specifications”

“specifications” means a detailed description of a drug, the raw material used in a drug or the packaging material for a drug and includes

  • (a) a statement of all properties and qualities of the drug, raw material or packaging material that are relevant to the manufacture, packaging and use of the drug, including the identity, potency and purity of the drug, raw material or packaging material,

  • (b) a detailed description of the methods used for testing and examining the drug, raw material or packaging material, and

  • (c) a statement of tolerances for the properties and qualities of the drug, raw material or packaging material. (spécifications)

  • SOR/82-524, s. 3;
  • SOR/85-754, s. 1;
  • SOR/89-174, s. 1;
  • SOR/97-12, s. 6;
  • SOR/2010-95, s. 1.
Previous Version

C.02.002.1. This Division does not apply to fabricating, packaging/labelling, testing, storing and importing of antimicrobial agents.

  • SOR/2004-282, s. 3.

Sale

C.02.003. No distributor referred to in paragraph C.01A.003(b) and no importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with the requirements of this Division.

  • SOR/82-524, s. 3;
  • SOR/97-12, s. 7;
  • SOR/2000-120, s. 8;
  • SOR/2010-95, s. 2(F).
Previous Version

Premises

C.02.004. The premises in which a lot or batch of a drug is fabricated, packaged/labelled or stored shall be designed, constructed and maintained in a manner that

  • (a) permits the operations therein to be performed under clean, sanitary and orderly conditions;

  • (b) permits the effective cleaning of all surfaces therein; and

  • (c) prevents the contamination of the drug and the addition of extraneous material to the drug.

  • SOR/82-524, s. 3;
  • SOR/97-12, s. 8;
  • SOR/2010-95, s. 3.
Previous Version