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Canadian Importers of Active Pharmaceutical Ingredients

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(API) are required to be licensed by Health Canada. An important part of the licensing application process is the development, implementation and maintenance of Good Manufacturing Practices (GMP).

Chemical Compliance CA Inc. has the expertise to develop the compliance program that includes:

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  • Creation of Table A – Foreign Building registry
  • Creation of FRM-0033 Drug Establishment Licence Application
  • Creation of GMP program to meet the requirements of GUI-0104 for importers                                                                                                      of API covering:
    o Premises
    o Equipment
    o Personnel
    o Sanitation
    o Quality Control
    o Record keeping
    o Traceability and recall
    o Stability and ongoing stability
    o Annual quality reports
    o Supplier and customer written quality agreements
    o Employee education and training to maintain DEL and GMP
  • Create self-inspection and audit check list

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