1. PURPOSE:
1.1. To comply cGMP requirements
of dispensing.
2. SCOPE:
2.1. It is applicable in dispensing section of raw material store.
3. RESPONSIBILITY:
3.1. Quality Assurance Manager
3.2.Production Manager
3.3. Store In Charge
4. PROCEDURE:
4.1. Monitor and record
cleanliness of dispensing room including floor and walls.
4.2. Monitor personal wearing of
the dispensing workers (masks, Gloves, Cap).
4.3. Monitor and record the
temperature and humidity of dispensing room and verify it.
4.4. Monitor and record velocity
of air coming from laminar flow hood in dispensing room of raw material store.
4.5. Before commencement of any
weighing the balance should be calibrated and there should be no dust on the
platform, dial and beam.
4.6. Verify the name of each
active and inactive material, tare weight, gross weight and net weight of the
material being dispensed.
4.7. Check out Q.C ref. number
against each container of raw material.
4.8. For every drug substance,
its dedicated equipment is used which must be clean & labeled with the name
of corresponding raw material.
4.9. When one material which has
to be dispensed from two lots; quantity from each lot must be recorded.
4.10.
The material dispensed should be clearly labeled with the name of
material, batch number, Q.C. ref. number, name of the product (for which it is
dispensed), the net weight and the gross weight.
5.
List of Recipients:
5.1.Quality Assurance Manager
5.2.Production Manager
5.3.Store In Charge
6.
Attached Forms/ Annexure:
6.1.Monitoring Of Dispensing
No comments:
Post a Comment