Objective
Is to help the trainees to understand the Good Manufacturing Practices (GMPs) requirements of Canada Natural Health products & Non-Prescription drugs Directorate.
Learning Outcome
This course will provide valuable support to nutraceutical companies
After completing this course, participants will be equipped with the needed information to implement the GMP requirements and to fulfill their role in assuring the quality of a NHPs, before it is made available for sale. The course topics includes:
- How to conduct internal audit to ensure that the Premises and Equipment are fulfilling the GMPs basic requirements?
- The Quality Assurance person responsibilities,
- How to establish a site Sanitation Programs.
- How to examine the suppliers raw materials Certificate of Analysis?
- How to establish your finished products specifications. and product release process?
- How to establish the product shelf-life?
- How to manage the product complaints and Recall?
- In addition, how to establish a good documentation system?
who Will Benefit?
- Quality assurance and regulatory personnel
- Operational (production) managers
- Middle-to-senior management
Handout Materials
When the training conducted On-Site, trainees will be given a binder, containing the training course slides and the exercises materials.
sources (Guidelines)
Health Canada: Natural and Non-prescription Health Products Directorate. Good Manufacturing Practices Guidance Document (Version 3.0) December 1, 2015
Know your instructor
Dr. Jalal Mokhalalati, B.Sc., M.Sc., Ph.D.
Dr. Mokhalalati holds a Ph.D. degree in the field of human nutrition from University of London. Since his graduation in 1981, he wrote a number of books and scientific papers, and he worked in various countries for different sectors, including teaching at the University of Gaza.
In 2001, Dr. Mokhalalati retired from Abbott Laboratories as the Head of Medical and Regulatory Affairs Department in S. Arabia and started his own consultation office in Canada to serve the food & drug industry in all aspects of establishment licensing (GMPs), and Health Products registration with Health Canada.
Certification
Trainees who participate in this program will receive a “Certificate of Achievement” from QMRS Education Center
Table of Contents
Health Canada GMPs for Natural and Non-Prescription Health Products
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Before Starting
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Module One: Prerequisite Information
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Module Two: Place
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Module Three: People
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Module Four: Processes
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Module Four: Operations
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Module Four: Inspection Program For Contractors
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Module Five: Products
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Module Five: Stability (Section 52)
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Module Five: Records
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Module Five: Recall and Recall Reporting
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Appendix I – GMP Requirements for Homeopathic Medicines
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Appendix II – Good Documentation Practices
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Appendix III – Risk Classification of NHPs GMP Observations
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References
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Glossary
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Course Completion