STANDARD OPERATING PROCEDURE FOR DESTRUCTION OF ANALYZED SAMPLE IN QUALITY CONTROL DEPARTMENT

1.0 OBJECTIVE

1.1 To lay down a procedure for the destruction of the analyzed Samples in the Quality Control department.

2.0 SCOPE

2.1 This procedure applies to the Pharmaceutical Manufacturing Facility of ________________

3.0 RESPONSIBILITY

3.1 Chemists – Quality Control

4.0 ACCOUNTABILITY

4.1 Head – Quality Control

5.0 PROCEDURE:

5.1 All the analyzed samples are kept in the “Destruction Bin”.

5.2 Solid samples shall be dissolved in a suitable medium (water or suitable solvent) and then drained in the drainage line of the common effluent treatment plant (CETP).

Note: In case antibiotics are active material/finished product, dissolve in 2 % NaOH solution prior to draining.

5.3 Analyzed acid and alkali samples shall be slowly mixed with plenty of water in the suitable beaker and then drained.

5.4 An analyzed liquid sample, which is soluble in water, shall dilute with Water and then drained.

5.5 After testing packing materials shall be destroyed as follows:

a) Labels, cartons, covers, leaflets, pouches, Aluminum foils, PVC films, LDPE Bags, Cotton, Rayon, Cut with scissors/Blade

b) Rubber Bung, Rubber stopper Cut with cutter.

c)Containers, Polypropylene closures Caps, flip-off seals, Aluminium Seals, and vials. Deform by using the hammer

d) Silica Gel canisters/bags Hammer/Scissor

5.5 Hand over the above scrap in a closed polythene bag labeled with the status label to the housekeeping department.

6.0 ABBREVIATIONS

6.1 Nil

7.0 REFERENCES

7.1 Nil

8.0 ANNEXURES

8.1 Nil


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