Biomedical Engineering Reference
In-Depth Information
SOP No.: QAS-032
Issued on:
Revision No.:
Initiator name:
3.3 There has been significant changes such as:
a. Modification in equipment directly contacting bulk
product or product container
b. Modification in equipment/facilities, which can affect air quality
c. Major changes in production personals
4. No. of units to be filled
MFM No.
List: QA director/QC director/managers QA/microbiological section head
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