Which documents and records will Drug Office officers focus on during a premises inspection?

The Department of Health’s premises inspection involves far more than checking the physical facilities. Reviewing documents and records is central to assessing whether your management system is effective. Officers will examine your documents systematically, much like auditors. The documents they typically focus on include: 1. **Quality Management System documentation**: the quality manual and complete set of Standard Operating Procedures (SOPs). 2. **Personnel records**: CVs and qualification documents for key personnel (such as the Person-in-Charge and quality manager), and training records for all staff. 3. **Premises and equipment documents**: the premises tenancy agreement and floor plan, validation/qualification reports for major equipment (such as cold rooms and refrigerators), and calibration certificates for all monitoring equipment (such as thermometers). 4. **Operational records**: complete temperature and humidity monitoring records (including any reports investigating out-of-range readings), cleaning records, pest-control records, and goods-in and goods-out records. 5. **Product-related records**: supplier and customer qualification files, purchase orders and sales invoices for medicines, and records of returned goods and recall handling. 6. **Controlled medicines records**: where applicable, the Dangerous Drugs Register and poisons sales records.