Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-027.00 Effective date: mm/dd/yyyy
Approved by:
Subject: Raw Material QA Audit Checks
46.1 PurPose
The purpose of this SOP is to provide a procedure for audit checks of dispensing raw material.
46.2 resPonsibility
The QAI will be responsible for following the procedure and the QA manager will be responsible
for the SOP compliance. The QA director is responsible for the overall system compliance.
46.3 Procedure
Computer documentation system is implemented for ensuring
a. FIFO (first-in first-out system of raw materials)
b. Check for issuance of correct quantities
c. Location of a particular lot
d. Inventory status of a particular lot of material
46.3.1
r
aw
m
aterial
Qa a
udit
c
heckS
1. The QAI has to confirm that
a.
The issuance is according to FIFO.
b.
All the entries on the computer are present and correct.
2. The QAI has to confirm that the quantities dispensed are correct and as per the master
manufacturing formula requisition.
3. The balance calculation is correct and tallies with the physical stock of the lot of the cor-
responding raw material.
4. In case of any discrepancy, investigate the cause of shortage or excess.
5. The weighing area manager will raise an inventory exception report for the accounts depart-
ment and the production director in case of physical shortage or excess of a raw material.
6. In cases where the in-use lot is quarantined (QA/QC HOLD), the next lot could be used and
if the quarantined lot is approved by QA/QC at a later time, then discontinue the use of the
lot taken after that and start using the older lot again with the label of
Re-Released ON
;
date is mentioned in the system.
7. The raw material of the next lot (which was in use) will have a notation “hold as previous
lot is now released.”
8. In case the lot is rejected, the computer dispensing/inventory system should have the
remarks or notation “rejected on _______.”
9. The QAI will check the balance quantity at the time of dispensing.
46.3.2 gmP c
heckS
The area QAI (weighing area) will check the general GMP of the weighing area daily as per SOP
QAS-000 and upon finding any anomaly, will raise the deviation citation format and will follow the
corrective action procedure.
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