Pharmaceutical Good Manufacturing Practice Regulations Article 137

Manufacturers shall establish and maintain documented procedures for implementing corrective and preventive action.Any corrective or preventive action taken to eliminate the causes of actual or potential nonconformities shall be to a degree appropriate to the magnitude of problems and commensurate with the risks encountered.Manufacturers shall implement and record any changes to the documented procedures resulting from corrective and preventive action.Manufacturers shall establish and maintain a documented feedback system to provide early warning of quality problems and for input into the corrective and preventive action system.Manufacturers shall gain experience from information feedback in the post-production phase, and the review of this experience shall form part of the feedback system.Manufacturers shall maintain records of all customer complaint investigations. When the investigation determines that the activities at remote premises contributed to the customer complaint, relevant information shall be communicated between the manufacturer and the remote premises.If any customer complaint is not followed by corrective and preventive action, the reason shall be recorded.Manufacturers shall establish reporting procedures to notify the central competent health authority of those incidents in which a harmful event has occurred.Manufacturers shall establish and maintain documented procedures for the issue of advisory notice for medical devices, and ensure these procedures shall be capable of being implemented at any time.