Pharmaceutical Good Manufacturing Practice Regulations Article 121

Manufacturers shall identify and implement any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.Manufacturers shall establish documented procedures for the issue and implementation of advisory notices. These procedures shall be capable of being implemented at any time.Manufacturers shall maintain the records of all customer complaint investigations. If investigation determines that the activities outside the manufacturers contributed to the customer complaint, relevant information shall be exchanged between the organizations involved.If any customer complaint is not followed by corrective and/or preventive action, manufacturers shall authorize and record the reason.Manufacturers shall establish reporting procedures in accordance with the regulations of central competent health authority for the notification of adverse events or recall actions to the central competent health authority or its designated organization.