Disposal of QC Retain Samples & Batch Record Documents

 Objective:-

                        To ensure safe disposal of Documents & Product retain Samples.

 Scope:-

This procedure is applicable to disposal of Batch Records of expired products & QC retain samples (Product / Raw Materials)

Responsibility:-

§  Quality Control Manager

§  Quality Assurance Incharg

Procedure:-

Document review & disposal is carried out at the end of each year.

1. Batch record documents & product retain samples of the products expired in previous year are collected from QC Retain Sample room.
2. Batch History records, labels, and cartons are shredded or safely burned.
3. The ampoules should be crushed.
4. Tablets and capsules are crushed.
5. The Antibiotic Powder Vials are disposed as follows:

i)                    Empty out the vials into a small plastic drum, rinse the vials and drain into the drum and add sufficient amount of water to make solution.

ii)                  In case of Raw Material weigh the powder and add water equal to half the quantity of powder. For example for 100 gm of powder add 50 gm of water and mix.

iii)                Add 4 ml of 10% Sodium Hydroxide Solution per 100 gm of powder to inactivate the Penicillin present in the powder.

iv)                Mix thoroughly and wait for about 15 minutes for inactivation of penicillin.

v)                  Transfer to the disposal pipe with plenty of water to flush the waste.

6. All disposal activities are performed under supervision of QA Officer.
7. Record the approximate quantities of solid / liquid materials disposed on Disposal Note, duly signed by QA Incharge
8. Documents disposal should be recorded on form F-01-04 and a copy sent to Quality Management Representative.