Good Manufacturing Practices for Herbal Medicinal Products

Program Objectives

By the completion of this program, participants will be able to:

• Understand the specific GMP requirements that apply uniquely to herbal medicinal products throughout the manufacturing lifecycle
• Distinguish between Good Agricultural and Collection Practice and GMP application points for herbal starting materials
• Establish robust supplier qualification and auditing programs for herbal substance suppliers
• Implement appropriate storage, handling, and processing controls for herbal substances and herbal preparations
• Develop comprehensive specifications for herbal substances, including identity, purity, and contaminant testing
• Design effective quality control programs addressing the heterogeneous nature of herbal materials
• Apply risk management principles to herbal medicinal product manufacturing operations
• Ensure compliance with EU regulatory requirements for traditional and well-established herbal medicinal products

Program Scope

This program encompasses the full spectrum of GMP requirements for the manufacture of herbal medicinal products, as outlined in EU GMP Annex 7 and supporting regulatory documents.

Regulatory Framework Coverage

• Application of GMP to different stages of herbal substance processing
• Relationship between Good Agricultural and Collection Practice and GMP
• Qualification requirements for herbal substance suppliers
• Documentation requirements for herbal starting materials
• Specifications for herbal substances, including binomial scientific names and plant part identification
• Contaminant testing, including pesticides, toxic metals, aflatoxins, and microbial contamination
• Storage conditions for herbal substances, including protection from pests and environmental factors
• Processing controls for cutting, drying, extraction, and purification operations
• Quality control laboratory requirements for herbal medicinal products
• Self-inspection and audit requirements for herbal manufacturing operations

Manufacturing Process Coverage

• Cultivation, collection, and harvesting of medicinal plants
• Cutting, drying, and primary processing of herbal substances
• Expression from plants and distillation operations
• Extraction processes, including solvent selection and temperature control
• Fractionation, purification, and concentration of herbal preparations
• Blending and formulation into finished dosage forms
• Packaging and labeling of herbal medicinal products

Quality Control Coverage

• Macro and microscopic examination of herbal substances
• Identity testing, including chromatographic and spectroscopic methods
• Assay of constituents with known therapeutic activity
• Marker compound analysis and specification setting
• Pesticide residue testing and acceptance criteria
• Toxic metal testing, including lead, cadmium, mercury, and arsenic
• Aflatoxin and mycotoxin testing
• Microbial contamination testing and limits
• Water content determination for herbal substances
• Foreign matter examination and acceptance criteria

Target Audience

This program is designed for:

• Manufacturing Managers in herbal medicinal product companies
• Quality Assurance Directors responsible for herbal product compliance
• Regulatory Affairs Specialists focusing on traditional herbal medicinal products
• Quality Control Laboratory Managers handling herbal substance testing
• Supplier Qualification and Procurement Professionals
• GMP Compliance Officers in herbal manufacturing facilities
• Auditors conducting supplier audits for herbal starting materials
• Technical Operations Directors managing extraction and processing
• Product Development Scientists working with herbal preparations

Certification

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