Annex 7 – Manufacture of Herbal Medicinal Products
Course duration: Allow 1 hour to 1.5 hours to complete this course.
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PIC/S Annex 7 – Manufacture of Herbal Medicinal Products
Herbal medicinal products must be manufactured in accordance with the regulations described in the PIC/s Guide to GMP and Eudralex Voume 4. This interactive e-Learning module introduces the user to the specific GMP regulations relating to the manufacture of herbal medicinal products.
The objectives of this PIC/S Annex 7 (Herbal Medicines Manufacturing) training module are:
- to provide an understanding of the requirements for control of starting materials
- to provide an understanding of the production of herbal medicines
- to provide an understanding of sampling and Quality Control requirements
- to provide an understanding of cleanliness and segregation requirements
- to provide an understanding of environmental considerations
Herbal Medicines – Good Manufacturing Practice (GMP)
GMP Compliance – Course Scope
The scope of this Online GMP training course on EU GMP Annex 7 applies only to the manufacture of herbal medicinal products. Due to their complex and variable nature, control of starting materials, and storage and processing will assume particular importance in the manufacture of herbal medicinal products.
The course focuses on the importance of starting materials in the manufacture of herbal medicinal products (herbal medicines or supplements) and ensuring these are of suitable quality.
Understandably consistent quality of the herbal substance requires detailed information of the control of its agricultural production. So the selection of seeds, cultivation and harvesting conditions represent important aspects of the quality of the herbal substance and can influence the consistency of the finished product.
- Recommendations on an appropriate quality assurance system for good agricultural and collection practice
- The course does not cover the guidance provided in the HMPC guidance document: Guideline on Good Agricultural and Collection Practice for starting materials of herbal origin.
This Online GMP training course PIC/S Annex 7 only applies to all herbal starting materials: medicinal plants, herbal substances or herbal preparations.
Certificate of completion for PIC/S Annex 7 (Herbal Medicines)
After successful completion of each course, learners will have the option of saving and/or printing a personalised training certificate that meets general PIC/S and EU GMP regulatory expectations. This training Certificate of Completion for PIC/S Annex 7 (Manufacture of Herbal Medicines) can be attached to a resume/CV and/or included in the personnel file and GMP Training Program records/files.