This Guide applies to the manufacture of APIs for medicinal products for both human and veterinary use. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not covered but should be performed in accordance with the principles and guidelines of GMP as laid down in national legislations and interpreted in the GMP Guide including its Annex 1.
This guideline is applicable to the manufacture of the finished dosage form of chemical and herbal medicinal products for human use intended for marketing authorisation. It also applies to variations for authorised products in cases where changes to the manufacturing process affecting the MA are proposed.
The principles described are in general also applicable to biological medicinal products. Where relevant, the principles of this guideline may also be applied to radiopharmaceuticals and to chemical investigational medicinal products.
Herbal medicinal products are medicinal products where the active ingredient consists exclusively of herbal substances or herbal preparations. Natural remedies are medicinal products where the active ingredient is of natural origin and consists of an animal part, a bacterial culture, a mineral or a salt.
The guide elaborates on the provisions of the Executive Order on herbal medicines. In addition, the requirements for manufacture, quality, harmlessness, documentation of impact, labelling etc. are elaborated.