QPs implemented in new Canadian GMP Regulations?

The 2009 Edition of the Canadian GMP Guidelines (GUI-0001) introduces new aspects into the Canadian GMP regulations. The changes are described in the respective cover letter. When reading some of the new parts one might think that these GMPs are influenced by European GMPs with their defined personal responsibilities. Some brand new requirements for individuals in charge of the Quality Control department might be considered as a step towards implementing something like a "Qualified Person" in Canada:

Regulation C.02.014:

  • "(1) No lot or batch of 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."

Interpretation :

  • "1. All decisions made by the quality control department pursuant to Regulation C.02.014 are signed and dated by the person in charge of the quality control department or by a designated alternate meeting the requirements described under Section C.02.006. "

Regulation C.02.006:

  • "Every lot or batch of a drug shall be fabricated, packaged/labelled, tested and stored under the supervision of personnel who, having regard to the duties and responsibilities involved, have had such technical, academic, and other training as the Director *) considers satisfactory in the interests of the health of the consumer or purchaser."
    [*) Director (directeur) - "The Assistant Deputy Minister, Health Products and Food Branch, of the Department of Health." (A.01.010)]

Interpretation:

  • "1. The individual in charge of the quality control department of a fabricator, packager/labeller, tester, importer, and distributor; and the individual in charge of the manufacturing department of a fabricator or packager/labeller;
    1.1 holds a Canadian university degree or a degree recognized as equivalent by a Canadian university or Canadian accreditation body in a science related to the work being carried out;
    1.2 has practical experience in their responsibility area;
    1.3 directly controls and personally supervises on site, each working shift during which activities under their control are being conducted; and
    1.4 may delegate duties and responsibility (e.g., to cover all shifts) to a person in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a course of study at a university, college or technical institute in a science related to the work being carried out combined with at least two years of relevant practical experience, while remaining accountable for those duties and responsibility."

The 2009 Guidelines also contains modified and/or new terminology and a set of Questions and Answers. Moreover, an annual product quality review has been implemented as well.

Link to Good Manufacturing Practices (GMP) Guidelines 2009 Edition (GUI-0001)

Compiled by
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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