PROGRAM OVERVIEW

This certification program provides regulatory professionals, quality assurance personnel, manufacturing staff, and compliance specialists with comprehensive knowledge of the Good Manufacturing Practices (GMP) requirements under Part C, Division 2 of the Canadian Food and Drug Regulations. The program covers GMP for drug products (GUI-0001), investigational medicinal products for clinical trials (GUI-0036), and active pharmaceutical ingredients (API) (GUI-0104). Participants will learn the regulatory framework, quality system requirements, premises and equipment standards, personnel qualifications, sanitation programs, raw material testing, manufacturing controls, quality control department responsibilities, packaging and labelling controls, finished product testing, record keeping, stability programs, and sterile product requirements.

PROGRAM SCOPE

This program encompasses the complete GMP framework governing pharmaceutical, biological, veterinary, and radiopharmaceutical drugs in Canada. Participants will learn the legal and statutory basis for GMP under the Food and Drugs Act and the Food and Drug Regulations. The program covers all aspects of drug manufacturing including quality management systems, premises design and construction, equipment qualification and calibration, personnel training and hygiene, sanitation programs, raw material testing and vendor certification, manufacturing control procedures, process validation, quality control department independence and responsibilities, packaging material testing, finished product testing, record keeping and data integrity, sample retention, stability programs, sterile product manufacturing, and medical gas requirements. Additional focus areas include self-inspection programs, recall systems, outsourced activities, and annual product quality reviews. The program also addresses specific GMP requirements for investigational medicinal products used in clinical trials (GUI-0036) and active pharmaceutical ingredients (GUI-0104).

• Regulatory foundation: Food and Drugs Act, Food and Drug Regulations Part C Division 2
• Quality management: Pharmaceutical Quality System, Quality Risk Management (ICH Q9)
• Premises: Design, construction, maintenance, contamination prevention, aseptic processing
• Equipment: Design, cleaning, calibration, qualification (DQ/IQ/OQ/PQ), computerized systems
• Personnel: Qualifications, training, hygiene, clothing, key personnel requirements
• Sanitation: Written programs, cleaning procedures, pest control, environmental monitoring
• Raw material testing: Specifications, identity testing, vendor certification, reduced testing programs
• Manufacturing control: Written procedures, master formulae, batch records, process validation, blending, recovery, reprocessing, reworking
• Quality control department: Independence, approval authority, complaint investigation, laboratory controls
• Packaging material testing: Specifications, identity testing, label control
• Finished product testing: Release specifications, certificate of analysis, confirmatory testing
• Records: Documentation, data integrity, ALCOA+, retention periods, electronic records
• Samples: Retention samples, quantity, storage conditions
• Stability: Protocols, ongoing programs, shelf life determination
• Sterile products: Aseptic processing, Annex 1 requirements
• Clinical trial materials: Annex 13, blinding, randomization, labelling (C.05.011)
• Active pharmaceutical ingredients: ICH Q7, starting materials, impurity profiles, retest dates

PROGRAM OBJECTIVES

Upon completion, participants will be able to:

• Explain the legal and regulatory basis for GMP under the Food and Drugs Act and Food and Drug Regulations
• Implement a Pharmaceutical Quality System incorporating GMP and quality risk management
• Design and maintain premises and equipment to prevent contamination and ensure clean, sanitary operations
• Ensure personnel are qualified, trained, and follow proper hygiene and clothing requirements
• Develop and implement sanitation programs including cleaning validation and environmental monitoring
• Establish raw material testing specifications and vendor certification programs
• Control manufacturing operations through master formulae, batch records, and process validation
• Maintain an independent Quality Control Department with authority to approve or reject materials and products
• Test packaging materials and control labels to prevent mix-ups
• Conduct finished product testing and issue certificates of analysis
• Manage records with data integrity principles (ALCOA+) and meet retention requirements
• Retain samples of raw materials and finished products
• Establish stability programs to determine shelf life and monitor ongoing stability
• Manufacture sterile products in compliance with aseptic processing requirements
• Apply GMP to investigational medicinal products for clinical trials
• Manufacture active pharmaceutical ingredients in accordance with ICH Q7

TARGET AUDIENCE

This program is designed for professionals who work in or support the drug manufacturing industry in Canada and internationally. The curriculum is relevant for individuals responsible for quality assurance, quality control, manufacturing, regulatory affairs, and compliance. Professionals seeking to understand or comply with Canadian GMP requirements will find the program valuable.

• Quality Assurance Personnel
• Quality Control Personnel (analysts, supervisors, managers)
• Manufacturing Personnel (production, packaging, labelling)
• Regulatory Affairs Professionals
• Validation Specialists
• Compliance Officers
• Auditors (internal and external)
• Importers and Distributors of drugs
• Wholesalers of drugs
• Contract Manufacturing Organizations (CMOs)
• Consultants to the pharmaceutical industry
• Health Canada Inspectorate personnel (as reference)

CERTIFICATION DETAILS

Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.