Herb Mark – The Good Herbal Manufacture and Supply Standard
The objective of the Herb Mark accreditation is to provide customers, that manufacturers and distributors who are accredited are working to best practice thus delivering a quality and safe product. The Good Herbal Manufacturing and Supply Standard is a combination of conventional GMP for pharmaceuticals and Food Safety Standard.
The standard was developed by a combination of 40 years GMP and Food Safety Standards experience supplemented by site visits to herbal product manufacturing companies to gain an understanding of their processes.
The result is an easy to follow and useful assessment tool to enable organisations to carry out a gap analysis which will then drive a continuous improvement program establishing best practice. Organisations will be audited against this standard on a regular basis, typically every two years.
The key elements are as follows:
- Quality Management System: A defined and workable system, commensurate with the complexity of the business. This is supported by a quality policy endorsed by the senior management. This will include risk assessment and HACCP.
- Personnel: Adequately resourced. All staff to be suitably qualified, trained with clearly defined roles and responsibilities.
- Premises and Equipment: Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out.
- Documentation: All documents need to be controlled and reviewed. Designed to be easily understood, providing clear and unambiguous information.
- Production: All processes to be clearly defined with supporting procedure sand work instructions.
- Quality: Ensuring all materials, intermediates, and finished products meet their specification with regards to safety and quality
- Out-Sourced Activities: Managing suppliers and contractors, with documented agreements defining responsibilities and deliverables.
- Complaints and Recalls: Formalised process for dealing with customer complaints and non- conformances.
- Self- Inspection: Self-evaluation and monitoring through internal audits
By following these guidelines and principles, incorporating risk management, and planned change control, the result will be right first time, delivering to the customer a safe and quality product.