Annex 07 – Manufacture of Herbal Medicinal Products

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PICS GMP Certificates - Annex 7 manufacture herbal medicinal products

The objectives of this training module are:

  • to provide an understanding of the requirements for control of starting materials
  • to provide an understanding of production
  • 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

The scope of this Online GMP training course on EU GMP Annex 7 applies only to the manufacture of herbal medicinal products, and due to their often complex and variable nature, control of starting materials, storage and processing assume particular importance in the manufacture of herbal medicinal products.

The course focuses on the importance of “starting material” in the manufacture of a herbal medicinal products and ensuring that it is 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 Annex 7 only applies to all herbal starting materials: medicinal plants, herbal substances or herbal preparations.