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29.06.2009
QPs in neuen kanadischen GMP-Regelungen implementiert?
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| Die Ausgabe der Canadian GMP Guidelines (GUI-0001) von 2009 führt neue Aspekte in die kanadischen GMP-Regelungen ein. Die Änderungen sind im betreffenden Begleitschreiben beschrieben. Beim Durchlesen einiger der neuen Teile möchte man meinen, diese GMP-Regelungen seien von europäischen Vorschriften mit ihren definierten persönlichen Verantwortlichkeiten beeinflusst worden. Einige brandneue Anforderungen an Personen, die die Qualitätskontrollabteilung leiten, könnten als Schritt in Richtung der Etablierung einer Art "Qualified Person" in Kanada angesehen werden: Regelung 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. "
Regelung 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." Die Guidelines von 2009 enthalten auch modifizierte und/oder neue Fachausdrücke und eine Reihe von Fragen und Antworten. Auch wurde ein jährlicher Product Quality Review umgesetzt. Link zu Good Manufacturing Practices (GMP) Guidelines 2009 Edition (GUI-0001) Zusammengestellt von
Wolfgang Schmitt
CONCEPT HEIDELBERG | |
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