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
|
|
No comments:
Post a Comment