Destruction of Rejected Materials in Phamraceuticals SOP

Standard operating procedure of destruction of material that fails to comply with the limits given in specifications.

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1.0 OBJECTIVE:

To lay down the procedure for destruction of rejected material.

2.0 SCOPE:

This SOP shall be applicable to Quality Control, Quality Assurance and Stores Dept.

3.0 RESPONSIBILITY:

3.1 Q.A Officer.

4.0 ACCOUNTABILITY:

4.1 Sr. Manager Q.A.

4.2 Head of the Q.A Department.

5.0 PROCEDURE:

5.1 Records:

5.1.1 Records showing the following details shall be maintained;

5.1.1.1 Date of destruction.

5.1.1.2 Name of material.

5.1.1.3 Quantity destroyed.

5.1.1.4 Method applied.

5.1.1.5 The record shall be duly signed by:

5.1.1.5.1 Head of Quality Control

5.1.1.5.2 Head of Production.

5.1.1.5.3 Security in-charge.

5.2 Precautions:

5.2.1 Proper safety measures and equipment shall be used during breakage of glass material and burning of paper material.

5.3 Liquids:

5.3.1 Liquids rejected shall be diluted by suitable quantity of water and shall be drained into the drainage system.

5.4 Solids:

5.4.1 Rejected glass material shall be broken and disposed as scrap.

5.4.2 Rejected overprinted packing material shall be destroyed by tearing.

5.4.3 Rejected powders shall be destroyed by making slurry in water and disposing into drain.

5.4.4 Other rejected printed material shall also be destroyed by tearing and subsequently burning.

5.5 Applicable to rejected/ excess labels, cartons, C.C. box labels and printed foils.

5.5.1 After receiving carton and C.C. box labels, check the cartons and C.C. box labels for batch printing details and reject the printed C.C. box labels and cartons and also the bottle labels printed online, on which the printed matters are smudged or illegible or rejected due to gumming problem etc. and count the same.

5.5.2 After completion of labeling and packing of a batch count the excess label/ cartons as well as rejected labels cartons during labeling and packing and keep them in rejected labels/ cartons storage drum in sealed condition.

5.5.3 Destroy the rejected/ excess labels / cartons by tearing and burning them in scrap yard, in presence of dept. In-charge and Q.A representative.

5.5.4 Record the rejection and destruction details in the printed packing material destruction record book and also in the B.M.R. 

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