Biomedical Engineering Reference
In-Depth Information
SOP No.:
Issued on:
Revision No.:
Initiator name:
(continued)
documents
dept.
yes
no
n/a
remarks
42. Master formula and method (core + coating)
Production
43. Batch manufacturing record for compression/
encapsulation
Production
44. Batch manufacturing record for compression
(graphical presentation)
Production
45. Weighing area/equipment checklists with printouts
of weighed materials/dispensed liquids from silos
with cleaning status labels (core + coating)
Weighing area
46. Weighing area documents compliance declaration
(core + coating)
Weighing area
Weighing area
47. Checklist for batch documents audit (core + coating)
Weighing area
48. Batch manufacturing record No. 1 (core + coating)
49. Disintegration time printout
QA
50. Temperature and RH and Δ
P
printout
Production
51. Time sheet
Production
52. Mfg. yield form
Production
Any other documents
Any batch-related deviation
Close-out
Audited by:
Date:
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