How detailed should my Standard Operating Procedures (SOPs) be when I first submit my application?

You do not need to submit a perfect final set of SOPs covering every detail with your initial application. However, you must prepare a core set of clearly structured draft SOPs to demonstrate to the regulator that you have systematically considered and planned your future operational processes. These drafts should cover at least all key areas of GSDP (Good Storage and Distribution Practice), including personnel and training, premises and equipment management, document control, receipt, storage, order processing, dispatch, transport, complaint handling, medicine recalls, returned goods handling and internal audits. Each SOP should have a clear title, purpose, scope, allocation of responsibilities and description of steps. During an on-site inspection, inspectors will sample these SOPs and may ask your Person-in-Charge about the procedures they describe to assess whether your quality management system is tangible and effective.