We have a Well-built and Highly secured Store for storage of the finished goods for distribution or sale. The storage conditions are the Store is maintained as per the requirement of the product e.g. air-conditioned storage, low temperature/low humidity storage etc.

We have products requiring refrigerated storage.

No rejected material is coming in the area where only released finished products are stored. The rejected materials are kept totally isolated in a separate area always under lock and key.

The finished good are distributed as per the marketing requisition/orders on first in first out basis. A complete record of the finished goods distribution is maintained and when the full batch is completely distributed the information for the whole batch distribution is edited and is available at any point of time. The distribution details include the list of purchaser, date of the sale and quantity, and other commercial information. This data is available product wise/batch wise. Such historical batch distribution details are retrievable immediately.

Arrangements for Handling of complaints:
Market complaints are normally raised by customers and FDA officials. We have a SOP on handling of market complaint in the following way:

  - Receiving of the complaint.

  - Recording all available data of the product/batch and nature of the complaint.

  - Evaluating the complaint.

  - Compare it with retained sample of the same product/batch.

  - Identify the reasons for the complaint.

  - Take corrective action.

  - Communicate to the complainant..

  - Record completely the investigations and action taken in the complaints file.

  - Review the market complaints trend at regular intervals.

Arrangements for Handling Product Recalls:
Recall procedure is followed as per SOP. Recall is initiated by the Quality Assurance department. The seriousness of the error is discussed in a joint meeting consisting of representative from QC, production, & the top management. The recall is instituted by sending a recall circular by fastest mode of communication available at that time, to all concern people at all concern locations. All efforts are made to receive and collect the maximum number of units of the batch at the point of availability.

If required, the QC head communicates to the FDA authorities. The involvement of FDA authorities depends upon the seriousness of the reason for product recall. Reasons for product recall are thoroughly investigated by the management & properly recorded. Based on the finding of these report necessary corrective actions are taken to avoid the recurrence of such cases in future.