Disposal of Retained Sample SOP


1.0   PURPOSE:

1.1.            To establish a method for safe disposal of QC Retained Sample & Batch Record Documents.


2.1.      This procedure is applicable to disposal of Batch Records of expired products &
              Retained Samples (Product/Raw Materials).


3.1.      Quality Assurance Manager
3.2.      Quality Control Manager
3.3.      QA Officer

4.0    PROCEDURE:

4.1.      Document review & disposal is carried out at the end of each year.
4.2.      Batch record documents & product retain samples of the products expired in previous year are collected from Retained Sample room.
4.3.      Batch History records, labels, and cartons are shredded or safely burned.
4.4.      Tablets and capsules are crushed.
4.5.      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.
4.5.1.   Transfer to the disposal pipe with plenty of water to flush the waste.
4.6.      All disposal activities are performed under supervision of QA Officer.
4.7.      Record the approximate quantities retained samples/BMRs disposed on Disposal Note (F-07-008), duly signed by QA Manager & Director.

5.0    REVIEW FREQUENCY:

SOP will be reviewed at least annually.


EVIDENCES OF RECORDS & REFERENCES
F-07-008 (Destruction Note)
FORMAL KPIs
(Key Performance Indicators)
Maintaining the record and availability of the record as and when required
GENERAL RISKS
CONTROL   MEASURES
CUSTODIAN
Risks
Impact


Retained sample has not been destructed properly
Expired product may be used/misused
Always destroy the products in the presence of QA personnel



QA Officer/
QA Attendant
BMR/Retained sample destroyed before completion of retention time
Record/sample availability will not be made when required
Make a rough list of records/retained sample along with Mfg. Date and Exp. Date, and get it checked by QA Manager before destroying


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