What areas does the Drug Office, Department of Health usually focus on during routine inspections, and how should we prepare?

Routine inspections by the Department of Health are intended to ensure that licence holders continue to comply with the relevant legislation and codes of practice. Inspections are usually unannounced, although advance notice may also be given. The main areas checked include: 1. Premises and facilities: whether they meet the standards set at the time of licensing, particularly whether the warehouse environment for medicine storage meets the requirements. 2. Documents and records: the main focus of the inspection, including records of medicine purchases, sales and stock, as well as temperature monitoring and staff training records. 3. Operation of the Quality Management System: inspectors will sample-check whether your Standard Operating Procedures (SOPs) are being implemented effectively. 4. Personnel qualifications and responsibilities: ensuring that personnel in key roles have the relevant qualifications and clearly understand their responsibilities. To prepare, ensure all documents and records are well organised and readily accessible, and provide staff with regular training and mock inspection exercises so they can remain composed and answer questions accurately during an inspection.