GMP Medical Devices

GMP rules are required at every production stage by Turkey's Ministry of Health regulations and by European Union regulations alike. Because medical products contain elements that directly affect human health, medical devices are evaluated separately according to their risk classification. The standard covers every stage of a medical device, from raw-material intake to production and packaging, with written documentation and retained records at each step. ISO 13485 for medical devices and EU CE rules also apply as a legal requirement. Effective implementation and evidence of these standards will satisfy the conditions of the GMP medical standard. GMP STANDARD: Purpose of the standard, scope, process definitions, process owners, process detail. GMP Rules: 5.1.1 Systematic review, 5.1.2 Process-flow validation, 5.2 GMP infrastructure, 5.2.1 Suitable personnel selection, 5.2.2 Suitable production area, 5.2.3 Suitable equipment, 5.2.4 Suitable material labelling, 5.2.5 Approved procedures, 5.2.6 Suitable storage areas, 5.2.7 Training, 5.2.8 Purchasing, 5.2.9 Traceability, 5.2.10 Service and storage, 5.2.11 Recall procedure, 5.2.12 Complaint management, 5.3 Document control, 5.4 Internal audit, 5.5 Nonconforming product procedure, 5.6 Corrective and preventive action, 5.7 Management review, 5.8 Maintenance and repair, 5.9 Human resources, 5.10 Pest control, 5.11 Calibration, 5.12 Purchasing, 5.13 Product and service process, 5.14 Cleaning and hygiene, 5.15 Production safety, 5.16 Monitoring and recall, 5.17 Storage, 5.18 Water control, 5.19 Quality control, 5.20 Continuous improvement.

You can consult Eurocert specialists for GMP certification.