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Good Manufacturing Practices Guidelines, 2002 Edition, Version 2 - Health Products and Food Branch Inspectorate

Good Manufacturing Practices Guidelines, 2002 Edition, Version 2 - Health Products and Food Branch Inspectorate

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Published by: j.k.kumar on Oct 08, 2007
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09/18/2012

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FrançaisContact UsHelpSearchCanada SiteHPFB Inspectorate OnlineHealth Productsand Food Branch HomeHealth Canada Home Inspectorate HomeAbout UsDrugsMedical DevicesEstablishmentLicencesBlood andDonorSemenCells, Tissues andOrgansLaboratoryProgrammeNatural HealthProductsInternationalGoodManufacturingPracticesConsumersHealthProfessionalsEnforcementActivitiesActs andRegulationsFormsSite Map
Good Manufacturing PracticesGuidelines, 2002 Edition, Version2
Contact Information and Complete Document for Printing
Table of Contents:
IntroductionQuality ManagementGlossary of TermsRegulation C.02.002 C.02.003Premises C.02.004Equipment C.02.005Personnel C.02.006Sanitation C.02.007 C.02.008Raw Materiel Testing C.02.009 C.02.010Manufacturing Control C.02.011 C.02.012Quality Control Department C.02.013 C.02.014 C.02.015Packaging Materiel Testing C.02.016
 
 C.02.017Finished Product Testing C.02.018 C.02.019Records C.02.020 C.02.021 C.02.022 C.02.023 C.02.024Samples C.02.025 C.02.026Stability C.02.027 C.02.028Sterile Products C.02.029Medical Gases C.02.030
Annex:
Annex A Internationally Harmonized Requirements for BatchCertificationAnnex B Application for Alternate Sample RetentionAnnex C ReferencesGMP Committee members
Introduction
These guidelines on Good Manufacturing Practices (GMP) refer toDivision 2, Part C of the Food and Drug Regulations. The guidelinesapply to pharmaceutical, radiopharmaceutical, biological, andveterinary drugs and were developed by Health Canada inconsultation with their stakeholders. These guidelines are designed tofacilitate compliance by the regulated industry and to enhanceconsistency in the application of the regulatory requirements.Division 1A, Part C of the Food and Drug Regulations definesactivities for which GMP compliance is to be demonstrated prior tothe issuance of an establishment licence. In addition to theseguidelines, further guidance in specific areas is provided in theannexes to this document or in separate documents.
 
The content of this document should not be regarded as the onlyinterpretation of the GMP Regulations, nor does it intend to coverevery conceivable case. Alternative means of complying with theseRegulations can be considered with the appropriate scientific justification. Different approaches may be called for as newtechnologies emerge.The guidance given in this document has been written with a view toharmonization with GMP standards from other countries and withthose of the World Health Organization (WHO), the PharmaceuticalInspection Cooperation/Scheme (PIC/S) and the InternationalConference on Harmonization (ICH).The present edition of this document reflects the results of regulatoryrevisions due to the implementation of the Mutual RecognitionAgreements (MRA) Framework. The MRA establishes mutualrecognition of GMP compliance certification and assessmentmethods by regulatory authorities of countries designated asequivalent.
Acronyms
API: Active Pharmaceutical IngredientDIN: Drug Identification NumberGMP: Good Manufacturing PracticesICH: International Conference on HarmonizationHPFBI: Health Products and Food Branch InspectorateNOC: Notice of ComplianceMRA: Mutual Recognition AgreementPIC/S: Pharmaceutical Inspection Cooperation/SchemeWHO: World Health Organization
GMP Sections applying to the establishment activity
ViewGMP Sections applying to the establishment activityTable(This will open in a new window with a file size of 10 K )(You may have to use the scroll bar to see the entire table) Top of page
Quality Management

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