Biomedical Engineering Reference
In-Depth Information
Attachment Vc
SOP No.: QAS-002
Revision No.:
Issued on:
Initiator sign:
Production Area Documents
Check the:
1. Inspection start-up check list with the release
label (manufacturing side)
2. Batch manufacturing record for
a.
Syrups/Drops/Suspension:
On the batch
manufacturing record for syrup/drops/
suspension check that
i. All the information regarding the
identity of batch is correct
ii. Record is duly signed by the
manufacturing supervisor
iii. Information related to vessel cleaning
is complete with the signatures of
the worker
iv. Yield calculation is correct
v. Temperatures of all the various
manufacturing stages, all the timings
of (homogenizer, agitator), vacuum
limits are present on the record and
are within the range specified in
the MFM
3. Was there any deviation from master
manufacturing formula/was any corrective
action taken/was it properly documented/was
corrective action report raised and made a part
of the batch document?
Remarks:
4. Batch yield final and at various in-process
stage is correct
5. Rejection verification at various stages of
processing and at final stage
Reviewed by:
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