We are a small wholesaler. Do we also need to establish a complete Quality Management System (QMS)?

Absolutely. Regardless of the size of your company, if you are a licensed pharmaceutical wholesaler, you must establish and operate a Quality Management System (QMS) that meets GDP requirements. GDP regulations and codes of practice apply to all licensees; there is no “small business exemption”. The complexity of the QMS may, of course, be proportionate to the size and complexity of the company’s business. A small wholesaler’s QMS need not be as extensive as that of a large multinational company, but it must include all the core elements: a documented quality policy and objectives; a clear organisational structure and defined responsibilities; written SOPs for all key activities (such as procurement, receipt, storage, sales, complaints and recalls); and systems for managing personnel, premises, documents, deviations and changes.