Vol. 144, No. 10 — May 12, 2010

Registration

SOR/2010-95 April 29, 2010

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1447 — Good Manufacturing Practices)

P.C. 2010-550 April 29, 2010

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act (see footnote b), hereby makes the annexed Regulations Amending the Food and Drug Regulations (1447 — Good Manufacturing Practices).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1447 — GOOD MANUFACTURING PRACTICES)

AMENDMENTS

1. The definition “quality control department” in section C.02.002 of the Food and Drug Regulations (see footnote 1) is repealed.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.003b) 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.

COMING INTO FORCE

8. These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT
ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Description

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 two-fold: 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 description of the issues and the reasoning behind the resulting amendments appear below.

Quality control requirements

Under the current Regulations, the requirements related to the quality control department apply only to fabricators, package/ 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 has amended 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 requires 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, packager/labellers and distributors.

As a result of the modification to C.02.013 (1), wholesalers are required, under C.02.015 (2), to investigate any complaint or information respecting the quality of a drug or its deficiencies or hazards that is received and cause corrective action to be taken as necessary.

The quality control department at a wholesale establishment, however, is not required to be a distinct organizational unit that functions and reports to management independently of any other functional unit. This is in recognition of the fact that the nature of wholesaler operations does not, in most circumstances, give rise to a conflict of interest between manufacturing and quality control personnel. Similarly, the person in charge of the quality control department is not required to approve the sale of each lot or batch of a drug, in recognition of the level of knowledge and expertise a wholesaler may have in this area. Therefore, wholesalers are specifically exempt from the application of C.02.013 (2) and C.02.014 (1).

Health Canada is also deleting the definition of “quality control department” in section C.02.002 because it merely references section C.02.013 and does not provide a true definition.

As outlined in Division 1A of Part C of the Food and Drug Regulations, wholesale is defined as a means to sell any of the following drugs, other than at retail sale, where the seller’s name does not appear on the label of the drugs:

(a) a drug listed in Schedule C or D to the Act or in Schedule F to these regulations or a controlled drug as defined in subsection G.01.001(1); or

(b) a narcotic as defined in the Narcotic Control Regulations.

Premises

Pharmaceutical establishments should be designed and constructed in a manner that permits cleanliness and orderliness while avoiding contamination. If an establishment that stores drugs does not have effective controls in place, there is potential for contamination between products that should be under quarantine and products that are available for sale. Storage under inappropriate environmental conditions may also affect the quality of a drug. Health Canada is therefore amending section C.02.004 so that current construction and maintenance requirements also apply to the premises in which a drug is stored.

Complaints on quality

The current Regulations require the head of the quality control department to investigate all complaints they receive. “Complaint” may be narrowly construed as a formal expression of dissatisfaction from a customer or consumer. This narrow interpretation was not the intent of this provision. Consequently, Health Canada has amended the wording of C.02.015 (2) to be “complaint or information that is received respecting the quality of a drug or its deficiencies or hazards” to clarify that all information related to the quality of a drug must be investigated, not just consumer complaints.

In addition, the current regulations require the person in charge of the quality control department to investigate every complaint regarding the quality of a drug and cause corrective action to be taken where necessary. Health Canada has amended C.02.015 to require corrective action to be taken if the complaint or information received relates to an activity over which the department exercises control. If the complaint or information received does not relate to an activity over which the department exercises control, it shall be forwarded to the person in charge of the quality control department that does exercise quality control over the activity.

With the modification to the type of establishments required to have a quality control department, as previously outlined, the investigation requirement applies to fabricators, packager/ labellers, wholesalers, distributors and importers. The requirement to make and retain a record of the complaint and its investigation currently applies to distributors and importers. To correct this inconsistency in application, Health Canada requires fabricators, packager/labellers, and wholesalers to make and retain these records under C.02.023. In addition, a record shall also be retained of the corrective action taken and the name and address of the person to whom it was forwarded, as applicable. The Good Manufacturing Practices (GMP) Guidelines, 2009 Edition (GUI-0001), state that the record must be retained for a period of one year after the expiration date of the lot or batch of the drug.

Health Canada has added “quality” to “control department” to be consistent with the French version of this provision, as well as the remainder of the English Regulations.

Alternatives

Many of the amendments are codifications of existing interpretations of the Regulations, in order to better align the Regulations with evolving regulatory interpretation. Consequently, no alternatives to regulation were appropriate for these amendments. Similarly, the modifications aimed at addressing consistencies between the English and French versions of the Regulations, or to have consistent terminology within the English Regulations, could not be achieved by any means other than regulation. The remaining modifications involve ensuring consistency between French and English versions of the Regulations and deleting the unnecessary definition of quality control department.

Benefits and costs

Wholesalers will incur the cost of maintaining a quality control department on their premises. This cost is not considered to be great, particularly because the quality control department is not required to be a distinct organizational unit. Wholesalers will also bear the cost of creating and retaining records of investigations into complaints and information related to quality. Wholesalers are required to retain the records for a period of at least one year after the expiration date of the lot or batch of the drug. The potential benefits to the health and safety of Canadians that such investigations and records would provide far outweigh the estimated costs. Retaining the records permits thorough and complete investigations in the event of subsequent quality-related problems with the drug.

The remaining amendments will have neither an additional cost nor benefit to industry, government or Canadians as they simply codify existing practices or correct minor inconsistencies.

Consultation

A Letter to Stakeholders outlining the proposed amendment was published on the Health Products and Food Branch Inspectorate Web site and sent to affected stakeholders on January 10, 2005. In addition, the proposed amendment was also pre-published in the Canada Gazette, Part I, on September 30, 2006, followed by a 75-day comment period. During this period, four responses from industry associations were received. While some stakeholder responses applauded the proposed amendments, others questioned the appropriateness of the responsibilities to be fulfilled by wholesalers. More specifically, the comments suggested that a complete investigation by a wholesaler should not be necessary if the complaint received has been forwarded to the product manufacturer. As such, the amendments to C.02.015 and C.02.023 were redrafted to more accurately reflect the responsibility of a wholesaler, regarding activities within their span of control, in investigating complaints on quality.

Most recently, a Letter to Stakeholders outlining the proposed amendment was published on the Health Products and Food Branch Inspectorate Web site and sent to affected stakeholders on October 6, 2009. In addition, the proposed amendment was also pre-published in the Canada Gazette, Part I, on September 26, 2009, followed by a 75-day comment period. During this period, one response was received from industry.

The comment suggested that the terms “information,” “deficiencies” and hazards” be clearly defined because these terms are broad such that they may trigger investigations which are not related to the quality of the drug. Health Canada agrees that the terms are broad but has determined that investigations are warranted in order to assess whether the quality of the drug is at issue and the appropriate course of action.

Compliance and enforcement

This amendment does not alter existing compliance mechanisms under the provisions of the Food and Drugs Act and Regulations enforced by the Health Products and Food Branch Inspectorate. Current compliance mechanisms include compliance verifications and investigations, supported by establishment licensing and laboratory analyses, and compliance monitoring, including activities such as good manufacturing practices inspections.

Contact

Kim Dayman-Rutkus
Director
Policy and Strategic Planning Division
Health Products and Food Branch Inspectorate
Health Canada
250 Lanark Avenue
Address Locator: 2006C
Ottawa, Ontario
K1A 0K9
Telephone: 613-954-6785
Fax: 613-957-9392
Email: insp_pol@hc-sc.gc.ca

Footnote a
S.C. 2005, c. 42, s. 2

Footnote b
R.S., c. F-27

Footnote 1
C.R.C., c. 870

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