Destruction of Control Samples (Raw Material & Finished product) in Pharma

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. 

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