Chartered Engineer certification required to verify ANDA/DMF inputs and quantities for pharmaceutical export authorisations under export control. Appendix 32C mandates a Chartered Engineer (Chemical) certificate for advance authorisation applications, requiring the engineer to confirm registration ... Summary
Chartered Engineer certification required to verify ANDA/DMF inputs and quantities for pharmaceutical export authorisations under export control.
Appendix 32C mandates a Chartered Engineer (Chemical) certificate for advance authorisation applications, requiring the engineer to confirm registration and that the overseas regulator's approval pertains to the applicant's DMF or ANDA. The engineer must verify and certify technical descriptions, specifications and quantities of inputs in the ANDA/DMF against the ANF 4 J declaration, provide tabulated details comparing inputs with SION or adhoc norms, apply the specified solvent allowance rule, and accept penal liability for incorrect certification; deemed exports follow ANDA/DMF-based verification.
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