Testing
Article 46
1. Appropriate laboratory tests to determine conformity to specifications shall be conducted for each batch of active substance and intermediates thereof. 2. An impurity profile describing the identified and unidentified impurities present in a typical batch produced by a specific controlled production process shall be established for each active substance. The impurity profile shall include: (a) the identity of the impurity or some qualitative analytical designation (e.g. retention time); (b) the range of each identified impurity; (c) a classification of each identified impurity (e.g. inorganic, organic, solvent). 3. By way of derogation from paragraph 2, impurity profiles are not necessary for active substances from herbal or animal tissue origin. 4. The impurity profile shall be compared at appropriate intervals against the impurity profile in the terms of the marketing authorisation or compared against historical data in order to detect changes to the active substance resulting from modifications in raw materials, equipment operating parameters, or the production process. 5. Appropriate microbiological tests shall be conducted on each batch of intermediate and active substance where microbial quality is specified.