3.1  Responsibility3.1.1  Initiation of Statutory (Non Voluntary) Recall: Tine Authority shall beresponsible for requesting/ordering a product recall when the registration ofa product is cancelled for safety reasons, or when the product does notmeet regulatory requirements.In such instances, the Authority shall monitor the effectiveness of therecalling firm's actions and provide scientific, technical and operationaladvice where necessary.3.1.2 Initiation of Voluntary Recall - It is the recalling firm's sole responsibility torequest and implement the recall process by contacting all companies towhom the recall products have been distributed and ensuring the physicalremoval of the products from the market to the level required.In such cases prior notice should be given to the Authority.3.1.3 If the recalling firm's actions are deemed inadequate the Authority will takeappropriate actions to remove the product from sale or use. A firm's recalldoes not preclude enforcement actions being taken by the FDA, asdeemed appropriate, either during or following the completion of a recall.3.2 Product Recall TriggerAny product / batch(es) not meeting the defined quality standards has to berecalled from the market. Recall can be of two types; Voluntary Recall andStatutory Recall.3.2.1 Voluntary RecallVoluntary recall can be triggered by any incident that affects the quality, safetyand efficacy of the batch/product in question such asa) Batch(es) not complying with regulatory specifications during the postmarketing stability studyb) Batch(es) found to be defective during investigation of market complaint.c) During any failure investigation, if it is observed that the failure underinvestigation might have adverse quality impact on already released batch(e.g. possibility of contamination, mix-up, degradation etc.).d) If any unusual observation is noted during visual inspection of retentionsamples which indicate an impact on quality of the product after investigation.