- What is GPP?
- Why is GPP important?
- Official GPP Directives.
- the basic requirements of Good Production Practice.
- Principle and overview of the Pharmaceutical Quality System.
- Development, content and implementation of PQS.
- Key personnel.
- Background and duties of the Qualified person.
- Duties of the Head of production department.
- Duties of the Head of quality control.
- Person releasing the batch.
- Personnel training and hygiene.
- Production area.
- Storage area.
- Quality control areas.
- Ancillary areas.
- Generation and control of documentation.
- Types of documents and specifications.
- Manufacturing formula and processing instructions.
- Packaging instructions.
- Procedures and records.
- General principles.
- Prevention of cross-contamination in production.
- Guidelines for starting materials.
- Processing operations.
- Packaging materials and operations.
- Guidelines for finished products.
- General principles.
- Main tasks of the Quality control department.
- Technical transfer of testing methods.
- Transfer protocol.
- GPP Guidelines related to complaints.
- Classification of defects.
- Product Recalls.
- Reporting of Adverse events to Health Canada
- Professor: Pr. Peivand Pirouzi
After Health Canada has conducted their second inspection to grant a license to sell medical cannabis there will be additional inspections that may or may not be announced by Health Canada. It is important that the site be routinely inspected by a third party to ensure they are on track with GPP and the regulations. Crown College offers its expertise to conduct audits at a very realistic cost.
Licensed Producer (LP) Application
Standard Operating Procedures Technical Writing
As with any operation, Standard Operating Procedures (SOP) must be in place to ensure activities are followed, personnel are qualified and trained, consistency of operations and the quality and security of facilities adhered to.
These SOPs will cover such activities as physical security parameters (from pest control to building security requirements), Quality Assurance Qualifications, testing of products, sanitation program, employee training and hygiene, recall and recall reporting, document control, change control, labeling and packaging process and control. These just cover some of the activities required for a compliant and GPP facility as a Licensed Producer.
Every Licensed Producer of Medical Marijuana must have a security system set up. Given that Medical Marijuana is a narcotic strict control of medical cannabis must be adhered to. In addition building layout and design will tie into this security system. The regulatory provisions related to the security requirements include:
- Signage and Physical Barriers – eg. fence, signs stating unauthorized access is prohibited
- Entrance, Doors and Frames – Fire rated doors, appropriate locks, door closures, switches
- Openings, Ducts and Mechanical/Electrical Pass-Throughs
- Wall Construction
- Glazing Panel Security
- Monitoring and Detection
- Video Coverage
- Redundancy and Back-ups – all recordings of detected occurrences kept for 2 years and storage of video surveillance maintained.
- Access Control
- Security Systems Control Mechanisms – alarm codes, combinations
- Intrusion monitoring
- Record of Detected Matters
- Power Supply
- Air Filtration
Pre-License Inspection Assistance
Health Canada will conduct two inspections after the License to produce medical marijuana has been issued. The first inspection will occur after cultivation has begun. This is to ensure that Good Production Practices are followed, the building meets the requirements, personnel are qualified and/or trained among and to ensure the quality of production. The second inspection would occur prior to selling. This will cover other aspects of GPP including storing, packaging, shipping, record keeping and complete control through this process.
Routine Site Inspection
After Health Canada has conducted their second inspection to grant a license to sell medical cannabis there will be additional inspections (some that will not be pre-announced by Health Canada). It is important that the site be routinely inspected by a third party to ensure they are on track with GPP and the regulations.