Consultation on New Proposed GMP Guidance for Natural Health Products in Canada

Posted October 31, 2024

By: Jackie Menzies Yarnton, PRINCIPAL REGULATORY CONSULTANT, email

Consultation on New Proposed GMP Guidance for Natural Health Products in Canada

Introduction

Earlier this year, Health Canada moved the review of NHP site licenses from the Health Products and Food Branch (which covers NNHPD) to the Regulatory Operations and Enforcement Branch (ROEB) of Health Canada. This move was made to consolidate activities within Health Canada, as ROEB is currently responsible for establishment licensing for Drugs and Medical Devices, as well as inspections of all sites. This should additionally provide more clarity and consistency between site licensing reviews and site inspections.

Subsequent to this move, Health Canada has opened a consultation on the draft updated Good Manufacturing Practices (GMP) guidelines for Natural Health Products (NHPs). This update aims to increase clarity of the GMPs, as well as to modernize the current guidance, published in 2015, ensuring it remains relevant and effective in communicating how NNHPD expects NHP license and site license holders to behave.

Overview of Proposed Changes

The draft updated GMP guide for NHPs introduces several significant changes aimed at improving clarity, usability, and flexibility:

Enhanced Clarity and Ease of Use: The guidance document has been restructured and expanded to provide clearer guidance while maintaining flexibility for diverse NHP operations.
Alignment with Government of Canada Standards: Makes the guidance document compliant with HC’s requirements for clear language, accessibility, and format.
Updated Quality Control and Testing Requirements: Updates the requirements by taking advancements in analytical methods and quality assurance practices into account.
Enhanced Traceability and Supply Chain Management: Stronger guidance on requirements for supply chain management and traceability.
Integration of Risk Management Principles: Includes more modern risk management principles.
Addressing New Product Forms and Technologies: Includes considerations for new product forms and manufacturing technologies in the area of NHPs.

Detailed Comparison

Section	Current GMPs	Proposed GMPs
General Structure and Format	One single comprehensive document, organized into four main categories: Places, People, Processes, and Products	Written as multiple separate documents More user-friendly format following the order of the regulations under Part 3, GMP of the Natural Health Products Regulations (NHPR) A detailed overview and introduction section has been added
Scope and Applicability	Targeted primarily at manufacturers, packagers, labellers, importers, and distributors	Expanded scope to explicitly include: Testing activities Product licence holders Warehouses or storage facilities used by importers Third party retail storage locations Companies who sell directly to individual consumers (i.e. e-commerce) Clarification that GMP requirements do not apply to storage activities at retail establishments who only sell direct to consumers
Quality Systems	Limited discussion of quality systems	New section on NHP quality systems Introduction of guiding principles for quality systems Emphasis on the inter-relationship between quality systems, GMP, and quality risk management Recommendation for a well-designed and properly implemented quality system specific to NHPs
Risk Management	Limited discussion of risk management	Introduction of quality risk management principles Reference to ICH Q9: Quality Risk Management for examples of risk management processes and applications
Section 45 – Premises	Basic outlined requirements for cleanliness, organization, and prevention of contamination	Explicit requirement for a contamination prevention program More detailed requirements for water systems Specific mention of air handling systems and their maintenance More emphasis on risk-based approach to premises design and maintenance Expanded guidance on environmental monitoring
Section 46 – Equipment	Limited guidance on requirements for equipment design, maintenance, and cleaning	Requirement for equipment qualification More detailed guidance on computerized systems Explicit mention of calibration programs More emphasis on risk-based approach to equipment maintenance and cleaning Expanded guidance on equipment cleaning validation
Section 47 – Personnel	General requirements for qualification and training of personnel	Enhanced focus on: More detailed requirements for personnel training, education and competency assessment Documentation of personnel qualifications Roles and responsibilities of key personnel Specific requirements for designated QAP. Explicit mention of personnel hygiene programs
Section 48 – Sanitation Program	High-level cleaning and personal hygiene requirements	More comprehensive guidance on requirements for: Environmental monitoring programs Cleaning effectiveness monitoring Personnel health and hygiene practices Explicit mention of a contamination control strategy Greater emphasis on risk-based approach to sanitation
Section 49-50 – Operations	Basic requirements to maintain SOPs and recall systems	More detailed requirements for ongoing process validation More detailed guidance on in-process controls and monitoring Explicit mention of change control procedures Enhanced guidance on: Supplier qualification and management Outsourced activities management
Section 51 – Quality Assurance	Outlines the basic requirements for Quality Assurance personnel and their responsibilities.	Expanded role and responsibilities of the Quality Assurance Person (QAP) Explicit requirement for a Pharmaceutical Quality System (PQS) Explicit mention of quality risk management More detailed guidance on: Batch release procedures Deviation and CAPA management Product quality reviews Greater emphasis on senior management responsibility for quality More comprehensive approach to quality assurance throughout the product lifecycle
Section 52 – Stability	High-level requirements for stability testing	More comprehensive guidance on: Stability study design and testing protocols Ongoing stability programs Stability data evaluation and shelf-life determination Emphasis on using stability data for continuous improvement
Sections 53-58 – Records	Basic record keeping requirements	Enhanced guidance on: Data integrity principles Electronic records management Retention periods for different types of records and accessibility Greater emphasis on the importance of complete and accurate records
Sections 59-60 – Sterile Products	Limited guidance for sterile products	Greater emphasis on risk-based approach to sterile product manufacturing More comprehensive guidance on: Aseptic processing Sterilization validation Environmental monitoring for sterile operations
Section 61 – Samples	Basic sampling and testing requirements	– More detailed requirements for sample retention and storage conditions – Emphasis on using retention samples for ongoing stability testing
Section 62 – Recall Reporting	Basic Recall requirements	– More detailed requirements for recall procedures – Expanded detail on recall effectiveness checks – Enhanced guidance on: o Mock recall exercises o Root cause analysis for recalled products o Communication with regulatory authorities during recalls

Impact to Industry

Improved Compliance: Improved, clearer guidelines should lead to better understanding and implementation of GMP requirements, across the industry.
Enhanced Product Quality and Safety: More explicit controls and better-defined processes should result in higher GMP compliance, leading to increased quality and safer NHPs for consumers.
Global Competitiveness: Alignment with international best practices enhances the global competitiveness of Canadian NHP manufacturers and brands.

Conclusion

These proposed GMP guidelines are a step in the right direction to support the growing and evolving NHP industry in Canada. These changes align Canadian requirements more closely with global standards, and follow a more comprehensive quality system approach.

Key changes include:

More comprehensive and detailed guidance of all GMP sections
Greater emphasis on comprehensive quality systems, risk management, continuous improvement and using data to drive quality decisions and improvements.
Expanded scope to cover more activities/entities in the NHP supply chain
Alignment with international standards and best practices
Increased focus on data integrity and electronic records management

The consultation period is open from October 15, 2024, to December 16, 2024. This consultation is a valuable opportunity for industry stakeholders, to provide feedback and shape the future of GMP requirements for NHPs in Canada. By understanding the key changes and engaging in the consultation process, we can ensure that the updated guide effectively addresses the evolving needs of the NHP industry. If you have any questions as to how these changes will affect your business, please contact us and we’d be happy to help!

How Dell Tech Can Help

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Looking to navigate the regulatory landscape? We can seamlessly prepare and submit your NHP license applications, assist you in obtaining your Site Licence, and even act as your trusted Importer of Record. Dell Tech is fully equipped to submit alternative GMP evidence to the NNHPD, including Quality Assurance Reports (QAR) and Foreign Site Reference Number (FSRN) Authorization. We can also support your application for a Drug Establishment Licence (DEL).

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