SOP for Destruction of Rejected Materials : Pharmaguideline

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SOP for Destruction of Rejected Materials

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

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

Officer Quality Assurance

4.0 ACCOUNTABILITY

Sr. Manager Quality Assurance

5.0 PROCEDURE

5.1 Records

5.1.1 Records showing the following details shall be maintained:
Date of destruction, Name of material, quantity destroyed, method applied. The record shall be duly signed by the Quality control, Production head, and the 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 the slurry in water and disposing into the 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 and 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 the gumming problem etc. and count the same.
5.5.2 After completion of labeling and packing of a batch count the excess labels/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 the scrap yard, in presence of department In-Charge and Q.A. representative.
5.5.4 Record the rejection and destruction details in the printed packing materials destruction record book and also in the B.M.R

6.0 ABBREVIATION

6.1 SOP: Standard Operating Procedure
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