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Answer:

The ICH Q7A note for guidance, included as introduction to Volume 4, Part II of Volume 4 (the Guidance on Good Manufacture Practices (GMP) the rules governing medicinal products in the EU (‘Basic Requirements for Active Substances used as Starting MaterialsMaterials’) of the Rules Governing Medicinal Products in the EU, states in its introduction that it is applicable to the manufacturer of APIs for use in human (medicinal) products. It applies , which replicate the ICH Q7 guideline, states that the guidelines ‘apply to the manufacture of active substances for medicinal products for both human and veterinary use. They apply to the manufacture of sterile APIs active substances only up to the points point immediately prior to the APIs active substances being rendered sterile. The sterilisation and aseptic processing of sterile APIs active substances are not covered by this guidance, but should be performed in accordance with annex 1 of the EU GMP guidelines.the principles and guidelines of GMP as laid down in Directive 2003/94/EC and interpreted in the GMP Guide including its Annex 1.’