Corrective action: The manufacturer shall take action to eliminate the cause of non-conformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the non-conformities encountered. A documented procedure shall be established to define requirements for— (a) reviewing non-conformities (including customer complaints); (b) determining the causes of non-conformities; (c) evaluating the need for action to ensure that non-conformities do not recur; (d) determining and implementing action needed, including, if appropriate, updating documentation; (e) recording of the results of any investigation and of action taken; and (f) reviewing the corrective action taken and its effectiveness. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 158 of 248 8.5.3 Preventive action: The manufacturer shall determine action to eliminate the causes of potential non-conformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems. A documented procedure shall be established to define requirements for-— (a) determining potential non-conformities and their causes, (b) evaluating the need for action to prevent occurrence of nonconformities, (c) determining and implementing action needed, (d) recording of the results of any investigations and of action taken, and (e) reviewing preventive action taken and its effectiveness.