SOP on Storage, Handling and Destruction of Control Samples of Finished Products
Objective : To lay down a procedure for storage, handling, review and destruction of control samples of finished products.
Scope : This Standard Operating Procedure is applicable to Baddi formulation plant.
Responsibility
Officer /Executive – IPQA shall be responsible for Storage, Handling, review and Destruction of Control sample of finished Products
Head – QA shall be responsible for the implementation and compliance to this procedure.
Procedure
Officer /Executive – IPQA shall collect the control sample from every batch during packaging operation of the product for every market. Quantity of control sample shall be twice the quantity of sample required for one complete testing For Specific Product.
Control samples collected shall be daily transferred to Control Sample Room and kept in the designated place. Record of incoming control samples shall be maintained by IPQA personnel in the “Control Sample of Finished Product”.
Environmental conditions shall be monitored daily by IPQA personnel’s with the help of Hygrometer in the morning and evening. Record of the same shall be maintained by IPQA “Environmental Condition Record”.
In case control samples are required for investigation of market complaints/any other studies, the concerned department shall raise the control sample requisition form duly filled and approved by Head- QA . As per approved requisition IPQA personnel shall make necessary entry in register and the requisitions shall be filed in the designated file.
Control sample shall be visually inspected by IPQA personnel half yearly for any deterioration or damage to the product. Record of visual inspection shall be maintained by IPQA personnel in “Visual Inspection Record” .
Destruction of control samples of Finished Products shall be done after one year of expiry date of the product.
For destruction of expired control samples IPQA shall raise a requisition and forward the same for approval of Head-QA on the “Authorization Note” . Approved Authorization Note shall be filed in the designated file.
After Head QA approval destruction of control sample shall be planned by IPQA and on designated date destruction shall be done as follow:
Packaging material of control sample shall be destroyed as per SOP “Title-Scrap Management and Disposal of Scraps”.
Bulk material from control sample shall be destroyed by dispersing /dissolving in sufficient quantity of potable water (to form a paste) and finally through incineration.
The destruction record for Control samples shall be maintained by IPQA personnel.
All documents related to this SOP shall be kept in Control sample room.