Scope
This training program defines the complete knowledge and performance requirements for personnel involved in pharmaceutical manufacturing to become certified auditors for Good Manufacturing Practices (GMP) in the Canadian regulatory environment. The program integrates Health Canada GMP requirements from Part C, Division 2 of the Food and Drug Regulations, GUI-0001 (Good Manufacturing Practices Guide for Drug Products), GUI-0036 (Annex 13 – Drugs Used in Clinical Trials), and GUI-0104 (Good Manufacturing Practices for Active Pharmaceutical Ingredients) with auditing practices based on ISO 19011:2026 for internal, second-party (vendor, CRO, and supplier audits), and global regulatory compliance auditing.
The participant learns what Health Canada GMP requires across all aspects of pharmaceutical manufacturing, how to audit those requirements, and how to conduct audits across multiple jurisdictions and organizational boundaries. ISO 19011:2026 provides the methodological framework for planning, conducting, reporting, and following up on audits. The standard covers audit principles, audit programme management, conducting management system audits, and evaluation of auditor competence. It is applicable to all organizations that need to plan and conduct internal or external audits of management systems.
Regulatory Frameworks Covered
- Food and Drugs Act establishes the legal foundation for the regulation of drugs in Canada. It provides the authority for the Minister of Health to make regulations, including the Food and Drug Regulations.
- Food and Drug Regulations, Part C, Division 2 sets out the Good Manufacturing Practices requirements for drugs. This includes requirements for premises (C.02.004), equipment (C.02.005), personnel (C.02.006), sanitation (C.02.007, C.02.008), raw material testing (C.02.009, C.02.010), manufacturing control (C.02.011, C.02.012), quality control department (C.02.013, C.02.014, C.02.015), packaging material testing (C.02.016, C.02.017), finished product testing (C.02.018, C.02.019), records (C.02.020 to C.02.024.1), samples (C.02.025, C.02.026), stability (C.02.027, C.02.028), sterile products (C.02.029), and medical gases (C.02.030).
- GUI-0001 (Good Manufacturing Practices Guide for Drug Products) provides interpretation of Part C, Division 2 requirements for pharmaceutical, radiopharmaceutical, biological, and veterinary drugs. It is harmonized with WHO, PIC/S, ICH, and VICH standards.
- GUI-0036 (Annex 13 – Drugs Used in Clinical Trials) provides guidance for the fabrication and packaging/labelling of drugs intended for use in human clinical trials, including placebo and comparator products. It is based on the PIC/S Annex 13 with adaptations for Canadian requirements.
- GUI-0104 (Good Manufacturing Practices for Active Pharmaceutical Ingredients) applies to non-sterile APIs and their intermediates for use in human and veterinary drugs. It is harmonized with ICH Q7.
- ISO 19011:2026 provides the Guidelines for auditing management systems, covering audit principles, audit programme management, conducting audits, remote auditing methods, and competence evaluation. The 2026 edition embeds remote and hybrid auditing throughout the full audit lifecycle—from programme design through planning, opening meeting, conducting the audit, closing meeting, and reporting. It provides guidance on four pillars: auditing principles, management of an audit programme, conduct of individual audits from initial contact to follow-up, and auditor competence.
Auditing Practices Covered (ISO 19011:2026)
- Seven principles of auditing: integrity, fair presentation, due professional care, confidentiality, independence, evidence-based approach, and risk-based approach
- Audit programme management: objectives, risks, opportunities, resources, procedures, implementation, monitoring, review, and improvement
- Conduct of an audit: initiation, preparation, execution, reporting, and follow-up
- Remote and hybrid auditing methods: virtual audits, technology considerations, security, and contingency planning
- Competence and evaluation of auditors: personal behaviour, knowledge and skills, evaluation methods, and maintaining competence
- Second-party auditing: supplier qualification, vendor audits, and service provider oversight
Operational Areas Covered
- Pharmaceutical Quality System and Quality Risk Management
- Personnel qualifications, training, hygiene, and clothing requirements
- Premises design, construction, maintenance, and contamination prevention
- Equipment design, cleaning, calibration, and qualification (DQ, IQ, OQ, PQ)
- Documentation systems and record-keeping requirements
- Sanitation programs including cleaning validation and environmental monitoring
- Raw material testing specifications and vendor certification programs
- Manufacturing control procedures including master formulae, batch records, process validation, blending, recovery, reprocessing, and reworking
- Quality Control department independence and responsibilities
- Packaging material testing and label control
- Finished product testing and certificates of analysis
- Records and data integrity including ALCOA+ principles
- Sample retention requirements
- Stability programs including protocols and ongoing monitoring
- Sterile product manufacturing including aseptic processing requirements
- Medical gas requirements
- Clinical trial material requirements including Annex 13
- Active pharmaceutical ingredient requirements based on ICH Q7
Objectives
Upon completion of this program, the participant will be able to:
- Interpret and apply Health Canada GMP requirements from Part C, Division 2, GUI-0001, GUI-0036, and GUI-0104 to pharmaceutical manufacturing operations
- Understand and apply the seven auditing principles (integrity, fair presentation, due professional care, confidentiality, independence, evidence-based approach, and risk-based approach)
- Plan, manage, and execute internal, second-party, and global audits in full accordance with ISO 19011:2026
- Conduct supplier and vendor audits to assess compliance with Health Canada GMP and contractual requirements
- Conduct facility audits to assess premises, equipment, and utility systems for GMP compliance
- Develop audit checklists, sampling plans, and audit protocols tailored to pharmaceutical risks and regulatory requirements
- Collect objective evidence through on-site and remote interviews, observation, and document review
- Identify and classify non-conformities (critical, major, and minor) with clear justification referencing specific regulatory requirements
- Write non-conformity reports that are factual, complete, and actionable
- Prepare and distribute audit reports to appropriate management levels and stakeholders
- Notify management of critical findings using escalation procedures
- Track corrective and preventive actions using a formal tracking log with status codes
- Verify effectiveness of corrective and preventive actions
- Close an audit properly with closure memo and management acknowledgment
- Contribute audit results to management review and continual improvement
- Prepare organizations for Health Canada inspections and respond to inspection findings
Target Audience
This program is specifically designed for personnel involved in the manufacture, oversight, or auditing of pharmaceutical products in accordance with Health Canada GMP requirements. Typical roles include:
- Quality Assurance Personnel – responsible for independent monitoring of pharmaceutical manufacturing, conducting internal and vendor audits, and assuring GMP compliance across multiple regulatory frameworks
- Quality Control Personnel – responsible for laboratory operations, analytical testing, and stability programs; need to understand auditing principles and GMP requirements for QC laboratories
- Production and Manufacturing Staff – responsible for manufacturing operations; need to understand how their processes will be audited and how to maintain GMP compliance
- Regulatory Affairs Professionals – responsible for regulatory submissions and compliance; need to understand GMP requirements and auditing principles
- Supplier Qualification Professionals – responsible for supplier selection, qualification, and monitoring; need to understand auditing principles and supply chain GMP requirements
- Contract Manufacturing Organization Personnel – service providers conducting manufacturing activities on behalf of sponsors; need to understand auditing requirements
- Microbiology and Sterility Assurance Personnel – responsible for environmental monitoring, sterility testing, and contamination control; need to understand auditing principles for sterile products
- Validation Specialists – responsible for process validation, cleaning validation, and equipment qualification; need to understand auditing requirements for validation activities
- Audit Program Managers – responsible for planning, managing, and overseeing audit programmes across multiple regions and vendors
- Regulatory Compliance Officers – responsible for ensuring organizational compliance with global GMP regulations
- Importers and Distributors of drugs – need to understand GMP requirements applicable to their activities
- Wholesalers of drugs – need to understand GMP requirements for storage and distribution
- Consultants to the pharmaceutical industry – need to understand GMP requirements and auditing principles
Certification Requirements
To obtain the Canadian GMP Auditor Certification designation, the participant must complete the following steps:
- Complete all modules in sequence.
- Achieve a minimum score of 80 percent (8 out of 10 questions) on each module quiz.
Certificate of Completion
Upon successful completion of all module assessments and the final examination, you will receive a Certificate of Completion for the GMP Auditor Certification Program (Health Canada-Focused).
Certificate Details:
- Participant’s full name and designation
- Training program title and date of completion
- Authorized signatory and issuing organization details
- Unique certificate number for verification purposes
