They have been developed and are maintained by the QWP. They provide the EEA’s harmonised position on issues that can be subject to different interpretation or require clarification, typically arising from discussions or correspondence ich guidelines q1 to q13 pdf assessment procedures. These questions have been produced to provide clarification or additional information, and should be read in conjunction with the European Pharmacopoeia, quality guidelines and other guidance documents.
Removal of heavy metals tests from a specification – Substances without a Ph. General Monograph Substances for Pharmaceutical Use will require that elemental impurities are considered in a risk assessment and the Ph.