This intensive one-day workshop provides an in-depth review of Health Canada’s Good Manufacturing Practices Guide for Natural Health Products (GUI-0158), Version 4.
Participants will gain a thorough understanding of the updated regulatory requirements and their implications for all aspects of NHP manufacturing, packaging, labeling, importing, and distribution.
The training will focus on key changes, including the reorganization of the guide to align with the regulations, the new emphasis on quality systems and risk management, and the enhanced guidance on data integrity and documentation. Through interactive sessions, case studies, and practical examples, participants will learn how to implement and maintain a robust quality system to ensure compliance and product quality.
Objectives
This training course aims to provide professionals in the natural health product (NHP) sector with a thorough understanding of the new Good Manufacturing Practices (GMP) regulatory requirements and to prepare them for their implementation:
- Understand the key changes and new structure of GUI-0158, Version 4. This objective focuses on identifying and comprehending the updates from the previous version, including the reorganization of the guide, the new emphasis on quality systems, and alignment with other Health Canada documents.
- Comprehend the fundamental principles of a Quality System and Quality Risk Management. This objective aims to equip participants with a deep understanding of how a robust quality system and a risk-based approach serve as the foundation for GMP compliance.
- Identify and apply the specific GMP requirements for natural health products. This objective focuses on the practical application of the guidance, including requirements for premises, equipment, personnel, sanitation, and operational controls.
- learn how to implement effective documentation and data integrity practices. This objective highlights the critical importance of accurate record-keeping, from specifications to batch records, and ensures participants understand the principles of data integrity as outlined in the new guide.
- Understand and manage the product lifecycle from a GMP perspective. This objective covers the entire product journey, including stability, handling complaints, and implementing a robust Corrective and Preventive Action (CAPA) system for continuous improvement and compliance.
At the end of this training, participants will be able to apply new GMP requirements, minimize non-compliance risks, and optimize the quality of their natural health products.
Contents
The training is structured into four main modules, with breaks and a lunch period to allow for optimal learning and engagement.
Module 1: Introduction and Key Changes
- Welcome and Introductions: Trainer and participant introductions.
- Session Objectives: Overview of the day’s goals.
- Overview of GUI-0158, Version 4: Understand the purpose, scope, and target audience of the updated guide.
- Key Changes and Rationale: Discuss the major updates from Version 3, including the new structure, user-friendly language, and alignment with the Quality of Natural Health Products Guide.
Module 2: The Foundational Pillars of GMP
- Quality System: Delve into the core concept of a quality system as the overarching framework for compliance. Learn about the roles of senior management and the Quality Assurance Person (QAP).
- Quality Risk Management: Explore the principles of a risk-based approach to GMP. Discuss how to identify, evaluate, and control risks to product quality based on scientific knowledge.
Module 3: Core GMP Requirements
- Premises and Equipment: Review the requirements for designing, constructing, and maintaining premises and equipment to ensure sanitary conditions and prevent contamination.
- Personnel: Discuss the importance of adequate education, training, and experience for all staff involved in GMP activities.
Module 4: Operational Control and Documentation
- Sanitation Program: Learn how to develop and implement effective sanitation programs, including cleaning and sanitizing procedures.
- Operations: Examine the requirements for manufacturing, packaging, and labeling, including batch records and in-process controls.
- – Specifications and Records: Focus on the critical role of documentation. Discuss requirements for raw material specifications, finished product specifications, and the retention of records. This section will also cover data integrity and electronic records.
Module 5: Product Lifecycle and Compliance
- Stability and Samples: Understand the requirements for stability testing to support product shelf life and the proper handling of retention samples.
- Complaints, Recalls, and Returns: Review the procedures for handling product complaints and executing an effective recall system.
- Corrective and Preventive Action (CAPA): Introduce the CAPA process as a tool for continuous improvement, including how to investigate deviations and implement corrective measures to prevent recurrence.
Module 6: Q&A and Final Review
- Interactive Discussion: Open forum for questions and answers.
- Summary of Key Takeaways: Recap of the day’s most important concepts.
- Next Steps and Resources: Provide guidance on how to apply the learned principles to their specific operations.
Who Should Participate
This session is intended for quality managers, manufacturers, formulators, and all stakeholders involved in the production and distribution of NHPs, this training will cover all key aspects: quality management, process validation, raw material control, packaging, labeling, distribution, and preparation for Health Canada inspections.
Pedagogical Approaches
- Interactive presentations and case studies
- Practical exercises and scenarios
- Q&A and discussions on compliance challenges
Takeaways
- Training materials and certificate of attendance
- Document Templates: QMS, QRM, CAPA, Data Integrity, etc.
Speaker
Kossi Molley, Chimiste; LSSBB; PMP
