ARCHIVED - Avis : Consultation: Regulations Amending the Food and Drug Regulations 1447 - Good Manufacturing Practices

Health Products and Food Branch Inspectorate
250 Lanark Avenue
Ottawa, Ontario
Address Locator # 2006C
K1A 0K9

November 6, 2009

09-125694-832

To: Stakeholders

Re: Regulations Amending the Food and Drug Regulations 1447 - Good Manufacturing Practices

This is to inform you of the posting in Canada Gazette 1, Amendments to Division 2, Good Manufacturing Practices, of the Food and Drug Regulations - Schedule 1447 on Saturday, September 26, 2009 and to offer the opportunity to comment on the proposed changes. The amendments are outlined below and the full posting can be viewed on the Canada Gazette website.

1. The definition of "quality control department" in section C.02.002 of the Food and Drug Regulations is repealed.

2. Section C.02.003 of the French version of the Regulations is replaced by the following:

C.02.003. Il est interdit au distributeur visé à l'alinéa C.01A.003(b) et à l'importateur de vendre une drogue qui n'a pas été manufacturée, emballée-étiquetée, analysée et entreposée conformément aux exigences du présent titre.

3. The portion of section C.02.004 of the Regulations before paragraph (a) is replaced by the following:

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...

4. Section C.02.013 of the Regulations is replaced by the following:

C.02.013. (1) Every fabricator, packager/labeller, wholesaler, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall have on their premises in Canada a quality control department that is supervised by personnel described in section C.02.006.

(2) Except in the case of a wholesaler, the quality control department shall be a distinct organizational unit that functions and reports to management independently of any other functional unit, including the manufacturing, processing, packaging or sales unit.

5. Subsections C.02.014(1) and (2) of the Regulations are replaced by the following:

C.02.014. (1) Except in the case of a wholesaler, no lot or batch of a drug shall be made available for sale unless the sale of that lot or batch is approved by the person in charge of the quality control department.

(2) A drug that is returned to the fabricator, packager/labeller, wholesaler, distributor referred to in paragraph C.01A.003(b) or importer shall not be made available for further sale unless the sale of that drug is approved by the person in charge of the quality control department.

6. Subsection C.02.015(2) of the Regulations is replaced by the following:

(2) The person in charge of the quality control department shall cause to be investigated any complaint or information that is received respecting the quality of a drug or its deficiencies or hazards and cause any necessary corrective action to be taken, in the case where the complaint or information relates to an activity over which the department exercises quality control.

(2.1) In the case where the complaint or information that is received does not relate to an activity over which the quality control department exercises quality control, the person in charge of the department shall forward the complaint or information to the person in charge of the quality control department that exercises quality control over that activity.

7. Section C.02.023 of the Regulations is replaced by the following:

C.02.023. (1) On receipt of a complaint or any information respecting the quality of a drug or its deficiencies or hazards, every fabricator, packager/labeller, wholesaler, distributor referred to in paragraph C.01A.003(b) or importer of the drug, as the case may be, shall

(a) in the case of a complaint or information described in subsection C.02.015(2), make a record of the complaint or information, its investigation and, if applicable, any corrective action taken; and

(b) in the case of a complaint or information described in subsection C.02.015(2.1), make a record of the complaint or information, the name and business address of the person in charge of the quality control department to whom it was forwarded and the date on which it was forwarded.

(2) The fabricator, packager/labeller, wholesaler, distributor referred to in paragraph C.01A.003(b) or importer of the drug, as the case may be, shall retain the record for a period of at least one year after the expiration date of the lot or batch of that drug, unless their establishment licence specifies otherwise.

Any comments regarding these proposed amendments should be addressed to the Policy and Strategic Planning Division, Health Products Food Branch Inspectorate, 250 Lanark Avenue, 6th floor, Ottawa, Postal Locator 2006C, Ontario, K1A 0K9; by facsimile at 613-957-9392 or by email to Policy and Strategic Planning Division by December 9, 2009.

Yours truly,

Original signed by

Diana Dowthwaite
Director General