Standard operating procedure to destroy the control samples of raw material and finished product in different forms.
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1.0 OBJECTIVE:
To lay down the procedure to destroy the control samples of raw material and finished product in different forms.
2.0 SCOPE:
This SOP shall be applicable to Q.C Dept.
3.0 RESPONSIBILITY:
3.1 Officer Quality Assurance.
4.0 ACCOUNTABILITY:
4.1 Sr. Manager Q.A.
4.2 Head of the Q.A Department.
5.0 PROCEDURE:
5.1 Control sample will be taken for disposal one year after the expiry as per the following procedure:
5.2 Blister & strip packed tablets and capsules:
5.2.1 The carton/ catch cover shall be de-packed and contents shall be de-foiled and shall be collected in a double layer poly bag.
5.2.2 The carton/ catch cover/ insert/ MB box, etc shall be destroyed by shredding.
5.2.3 The contents (tablets/ capsules) shall be destroyed by dissolving in a container with water/ crushing. These will then be poured into the pit of ETP plant.
5.3 Bulk packed tablets & capsules:
5.3.1 Empty the contents in a double polythene bag.
5.3.2 The contents (tablets/ capsules) shall be destroyed as given in point 5.2.3.
5.3.3 Bulk container shall be de-shaped/ crushed & disposed in a drum/ container at the garbage area.
5.3.4 The labels shall be destroyed in the shredder.
5.4 Raw materials, active ingredients & bulk drug substances:
5.4.1 Empty the contents in the double polythene bag.
5.4.2 Empty the contents in a container with water and then pour it into the pit of ETP plant.
5.4.3 All the activity shall be performed in the presence of QA supervisor.