material before the storage of the approved herbal substance or before the start of manufacturing. 12. For the production of an herbal preparation, instructions should include details of solvent, time and temperatures of extraction, details of any concentration stages and methods used. 13. Due to the fact that medicinal plant/herbal substances 7 Due to the fact that crude drugs are an aggregate of Clause 14 is new, Nil are heterogeneous in nature, their sampling should be individual plants and contain an element of heterogeneity, however the carried out with special care by personnel with particular their sampling has to be carried out with special care by requirements to expertise. Each batch should be identified by its own personnel with particular expertise. Each batch should be keep reference documentation. identified by its own documentation. samples was already effective 14. A reference sample of the plant material is necessary, 8. Quality Control personnel should have particular on Annex 19 especially in those cases where the herbal substance is expertise in herbal medicinal products in trial to be able to not described in the relevant Pharmacopoeia. Samples of carry out identification tests and recognise adulteration, unmilled plant material are required if powders are used. the presence of fungal growth, infestations, non-uniformity within a delivery of crude plants, etc. 15. Quality Control personnel should have particular expertise and experience in herbal substances, herbal 9. The identity and quality of vegetable drug preparations preparations and/or herbal medicinal products in order to and of finished product should be tested as described be able to carry out identification tests and recognise below: adulteration, the presence of fungal growth, The Control tests on the finished product must be such as non-uniformity within a delivery of crude material, etc. to allow the qualitative and quantitative determination of 16. The identity and quality of herbal substances, herbal the composition of the active ingredients and a preparations and herbal medicinal products should be specification has to be given which may be done by using determined in accordance with the relevant current national markers if constituents with known therapeutic activity are or international guidance on quality and specifications of unknown. In the case of vegetable drugs or vegetable drug herbal medicinal products and traditional herbal medicinal preparations with constituents of known therapeutic products and, where relevant, to specific pharmacopoeial monographs
material before the storage of the approved herbal substance or before the start of manufacturing. 12. For the production of an herbal preparation, instructions should include details of solvent, time and temperatures of extraction, details of any concentration stages and methods used. 13. Due to the fact that medicinal plant/herbal substances are heterogeneous in nature, their sampling should be carried out with special care by personnel with particular expertise. Each batch should be identified by its own documentation. 14. A reference sample of the plant material is necessary, especially in those cases where the herbal substance is not described in the relevant Pharmacopoeia. Samples of unmilled plant material are required if powders are used. 15. Quality Control personnel should have particular expertise and experience in herbal substances, herbal preparations and/or herbal medicinal products in order to be able to carry out identification tests and recognise adulteration, the presence of fungal growth, non-uniformity within a delivery of crude material, etc. 16. The identity and quality of herbal substances, herbal preparations and herbal medicinal products should be determined in accordance with the relevant current national or international guidance on quality and specifications of herbal medicinal products and traditional herbal medicinal products and, where relevant, to specific pharmacopoeial monographs 7 Due to the fact that crude drugs are an aggregate of individual plants and contain an element of heterogeneity, their sampling has to be carried out with special care by personnel with particular expertise. Each batch should be identified by its own documentation. 8. Quality Control personnel should have particular expertise in herbal medicinal products in to be able to carry out identification tests and recognise adulteration, the presence of fungal growth, infestations, non-uniformity within a delivery of crude plants, etc. 9. The identity and quality of vegetable drug preparations and of finished product should be tested as described below: The Control tests on the finished product must be such as to allow the qualitative and quantitative determination of the composition of the active ingredients and a specification has to be given which may be done by using markers if constituents with known therapeutic activity are unknown. In the case of vegetable drugs or vegetable drug preparations with constituents of known therapeutic Clause 14 is new, however the requirements to keep reference samples was already effective on Annex 19 Nil trial