SOP Procedure:
I herewith confirm, that I even order drugs without certificate of analysis, means:
I herewith confirm, that I even order drugs without certificate of analysis, means:
- without full testing for compliance with the specifications according to the valid Ph. Eur. monograph (or subordinate valid ones, e.g. DAB, DAC)
- without testing for compliance with the limits according to Ph. Eur. (current version) 2.8.13 Pesticide residues
- without testing for compliance with the limits according to Ph. Eur. (current version 2.8.18 Aflatoxin B1 as well as the Aflatoxin Prohibition VO)
- without testing for compliance with the heavy metal limits of the monograph "Herbal Drugs" according to Ph. Eur. (current version) 2.4.27 and
- without testing for compliance with the microbiological acceptance criteria according to Ph. Eur. (current version) 5.1.8, cat. A.
I am aware that I am thus not permitted to use the drug for the manufacture of either a prescription drug or a defect drug within the meaning of § 1 Para. 9 and 10 ApBetrO.
Please refer to the order confirmation for the drugs concerned.