Biomedical Engineering Reference
In-Depth Information
Attachment Va
SOP No.: QAS-002
Revision No.:
Issued on:
Initiator sign:
Manufacturing/Production Area Documents
Check the:
1. Inspection start-up check list with the release
label (manufacturing side)
2. Batch manufacturing record for
a.
Ointment and cream: On the batch
manufacturing record check that
i. All the information regarding the
identity of the batch are correct
ii. Record is duly signed by the
manufacturing supervisor
iii. Information related to the machine
cleaning is complete with the
signatures of the worker
iv. Yield calculation is correct
v. Temperatures (fat phase, water
phase), 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 MFM, was any
corrective action taken, was it properly
documented, was PCR 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
Reviewed by:
Page 2 of 5
 
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