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Description of the Fig 1. Application of GMP and Health Canada Oversight for Plant-Derived Biologic Drugs Produced in Whole Plants

This figure shows the relationship between the different stages of plant-derived biologic drug production, and the application of Good Manufacturing Practices (GMP) and Health Canada oversight.  In summary, the right side of the figure depicts the 3 stages of plant-derived biologic drug production; the left side of the figure depicts, for each of those 3 stages, whether GMP is applicable and the type of Health Canada oversight that is applied.

The figure is divided into 3 rows, which correspond to the 3 stages of plant-derived biologic drug production. The 3 stages are depicted by 3 identification boxes on the right-most side of the figure (indicated by thick-lined boxes). From top to bottom, the 3 rows or stages are identified as "Stock maintenance", "Upstream", and "Downstream".

In each row, to the left of the 3 identification boxes, there are main boxes (indicated by thin-lined boxes). The main boxes show what process materials belong to each of the 3 stages of plant-derived biologic drug production. In the first row, which is for the stock maintenance stage, there are 3 main boxes: (1) "Master and /or Working banks"; (2) "Non-transgenic host plant"; and (3) "Transgenic plant or vector". The main boxes are connected by an arrow to the header box of the second row. This header box is called "Banking materials".

In the second row, which is for the upstream stage, there is 1 main box, called "Transgenic plant (stable or transient expression)". This main box is connected by an arrow to the header box of the third row. This header box is called "Harvested material".

In the third row, which is for the downstream stage, there are 3 main boxes that are connected serially by arrows:  (1) the "Initial/final extract" box leads to (2) the "Drug substance" box which leads to (3) the "Drug product" box.

Down the left side of each of the 3 rows, there are 3 vertical sets of boxes that, from right to left of the main boxes, show: (1) the regulatory classification of process materials in that row (indicated by dotted lines); (2) what type of oversight from Health Products and Food Branch Inspectorate (HPFBI) would be expected for the process and which regulations would apply to the process in that row (indicated by double lines); and (3) what type of oversight from Biologics and Genetics Therapies Directorate (BGTD) would be expected for the process in that row (indicated by dashed lines).

In the first row, which is for the stock maintenance stage, the figure shows that (1) the regulatory classification is "Raw materials" (indicated by dotted lines); (2) HPFBI oversight is risk-based compliance and enforcement where either or both of the following would apply: (a) GMP in Division 2 of the Food and Drug Regulations, and Annex 2 to the GMP Guidance; and/or (b) GMP-like principles, and C.02.009 of the Food and Drug Regulations (all indicated by double lines); and (3) BGTD oversight is On-site Evaluation (OSE) in Section 12 of the Food and Drugs Act (indicated by dashed lines).

In the second row, which is for the upstream stage, the figure shows that (1) the regulatory classification is "Biological starting material" (indicated by dotted lines); (2) HPFBI oversight is risk-based compliance and enforcement where GMP-like principles, and C.02.009 of the Food and Drug Regulations would apply (indicated by double lines); and (3) BGTD oversight is OSE in Section 12 of the Food and Drug Act (indicated by dashed lines).

In the third row, which is for the downstream stage, the figure shows that (1) the regulatory classification is Bulk Process Intermediates "BPI" (indicated by dotted lines) for the first 2 main boxes ("Initial/final extract" and "Drug substance"), and the regulatory classification is "Drug in dosage form" for the third main box ("Drug product"); (2) HPFBI oversight includes a mandatory inspection where GMP in Division 2 of the Food and Drug Regulations, and Annex 2 to the GMP Guidance would apply (indicated by double lines); and (3) BGTD oversight is OSE in Section 12 of the Food and Drugs Act (indicated by dashed lines).