Quality Control of Supply

The development of the necessary manufacturing and testing processes has been completed, and a Canadian supply of research-grade product is available for researchers and applicants approved for supply. This means that the company has taken action to ensure they comply with Good Manufacturing Practices Guidelines (GMPs). The basic concepts of quality assurance, GMPs, and quality control are inter-related and are described in these guidelines. These GMPs ensure that drugs are consistently produced and controlled to maintain the quality standards appropriate to their intended use.

Quality assurance is a wide ranging concept and covers all matters, which individually or collectively influences the quality of the drug.

GMPs are concerned with ensuring, among other activities, that:

• Manufacturing processes are clearly defined, controlled and any changes are evaluated;
• Personnel are qualified and trained;
• Adequate space and facilities are available;
• Suitable equipment and services are provided;
• Approved and clearly delineated procedures and instructions are available;
• Operators are trained to carry out approved procedures and to document the results; and
• Records are maintained of all aspects of the operations carried out at the company.

Quality control is concerned with ensuring, among other activities, that:

• Samples of raw materials and packaging materials, and bulk or finished product are taken by trained personnel as per approved, written procedures, and records of these actions are maintained;
• Test methods are validated;
• Records are made of the tests carried out and the results obtained;
• Results of all tests are assessed against specifications to ensure compliance;
• Product assessment includes a review and evaluation of all relevant production documentation and any deviations that were encountered; and
• A drug is not released for sale or supply prior to approval by the quality control department.

PPS has taken action to ensure that they have met all the required criteria for drug production, and to date have:

• Completed the renovations to ensure that the premises are suitable for production and harvesting;
• Hired and trained staff for cultivation and harvesting;
• Grown and harvested material;
• Developed required Standard Operating Procedures to be used in the operation; and
• Developed and validated test methods that have been, and will continue to be used.

Regular meetings are being held with company representatives to ensure that the project progresses in an acceptable manner. Marihuana produced domestically is being used for research to gather scientific information on the safety and efficacy of the drug in alleviating patients' symptoms that are unresponsive to currently available treatments. It is also used to supply individuals authorized by Health Canada to access marihuana for medical purposes.