Understand ICH Q7 S2

Should GMP according to ICH Q7 be applied for manufacturing steps before the defined ‘API starting material' i.e. steps not identified in grey in Table 1? ICH Q7 does not apply to steps prior to the introduction of the API starting material. However, there is an expectation that an appropriate level of controls suitable for the production of the API starting material should be applied [ICH Q7, 1.3]. Normally, the ‘API-starting material’ is defined in the regulatory filing by the applicant and approved in the regulatory reviewing process. Additional guidance is provided to define and justify ‘API starting material’ derived from various sources [ICH Q11, 5]; for master cell banks, see [ICH Q5B; ICH Q5D]