Canadian GMP Regulations

Canadian Good Manufacturing Practices (GMP) regulations are the guidelines and rules that govern the manufacturing, labeling, packaging, storing and selling of drugs in Canada. Health Canada is the federal department responsible for monitoring processes and guidelines that affect the health of Canadians. It is also responsible for the development of GMP regulations and necessary updates or modifications. All manufacturers, distributors and sellers of drugs must ensure that the drugs they deal with are manufactured, handled and stored in compliance with GMP regulations.

Cleanliness and Sanitation

• Companies can manufacture drugs only in premises that enable production in a clean, orderly environment. Strict monitoring of sanitary conditions by qualified personnel must ensure that drugs are free of tainting or contamination from other materials. The equipment used for manufacturing must be kept clean on all surfaces at all times. A worker who has a communicable disease or an exposed, open lesion must not enter any area where the drug is being manufactured, packaged or labeled.

Personnel

• Workers who fabricate, pack, label and store drugs must work under the supervision of qualified personnel who have the necessary academic and technical knowledge and training. Such personnel are responsible for the health of consumers. Personnel who fabricate a drug must have written documentation that outlines sanitation requirements such as cleaning of equipment and premises. The documentation must also include requirements for personal hygiene and clean clothing.

Testing of Raw Materials

• Personnel must test all raw materials against provided specifications before using them in the fabrication of drugs. If a raw material is subject to changes because of storage, it cannot be used in drug fabrication unless it has been tested again after the storage period and meets the necessary specifications. The fabricator must perform this testing on each batch of raw material that arrives at the fabrication area. This may not be necessary if the fabricator has adequate proof that the vendor who supplies the raw materials has followed specifications and if the raw materials were not in storage before delivery.

Production Control

• All manufacturers, packagers, labelers, sellers and distributors of drugs must follow written procedures provided by qualified personnel to ensure that the drug meets required specifications. They must also ensure that they can quickly recall complete batches of any drugs on the market. It is the responsibility of each fabricator and labeler to ensure that the manufacturing or labeling of drugs in somebody else's premises is done in compliance with the GMP regulations.

Quality Control

• Every fabricator, packager, labeler, wholesaler and distributor must have on the premises a quality department. This department is responsible for ensuring that all the raw materials used in the manufacture of drugs meet necessary requirements. Drugs can be sold only after the lots or batches have been tested and approved by the quality control department. If a drug is returned, it cannot be resold or reprocessed without the consent of this department. This department must also test and approve packaging material before its use.