1.0 OBJECTIVE:To lay down the procedure for destruction of control samples (Raw material and Finished product).
2.0 SCOPE:This SOP shall be applicable to Quality Control Dept.
3.0 RESPONSIBILITY:Officer Quality Assurance
4.0 ACCOUNTABILITY:Sr. Manager Quality Assurance
5.0 PROCEDURE:Control sample will be taken for disposal one year after the expiry as per the following procedure :
5.1 Blister & Strip packed tablets and capsules:5.1.1 The Carton/Catch cover shall be depacked and contents shall be defoiled and shall be collected in a double layer poly bag.
5.1.2 The carton/catchcover/insert/MB box etc shall be destroyed by shredding.
5.1.3 The contents (Tablets/Capsules) shall be destroyed by dissolving in a container with water/crushing. These will than be poured into the pit of ETP plant.
5.2 Bulk packed tablets & capsules :5.2.1 Empty the contents in a double polythene bag.
5.2.2 The contents (Tablets/capsules) shall be destroyed as given in point 5.1.3.
5.2.3 Bulk container shall be deshaped /crushed & disposed in a drum /container at the garbage area.
5.2.4 The labels shall be destroyed in the shredder.
5.3 Powders packed in laminated pouches or vials:5.3.1 Empty the contents in a container with water than these slurry shall be poured into the pit of ETP plant.
5.3.2 Pouches shall be destroyed by means of crushing in the shredder.
5.4 Liquids packed in vials, bottles or jars:5.4.1 Unseal the container and pour the contents in water and then pour into the pit of ETP plant.
5.4.2 Store the empty containers in a drum. Remove the labels and destroy all batch printed packing materials by shredding.
5.4.3 Wash the drum with tap water and keep it in the specified area
5.5 Raw Materials, Active Ingredients and Bulk Drug Substances:5.5.1 Empty the contents in the double polythene bag.
5.5.2 Empty the contents in a container with water and then pour it into the pit of ETP plant.
5.5.3 All the activity shall be performed in the presence of QA supervisor.
6.0 ABBREVIATIONS6.1 SOP : Standard Operating Procedure
6.2 QA : Quality Assurance
6.3 QC : Quality Control
6.4 Dept. : Department
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