Article
- Good Manufacturing Practices for Pharmaceutical Products (GMP)
- Pharmaceuticals Pre-Approval of Inspections
- Inspection of Pharmaceutical Manufacturers
- Inspection of Drug Distribution Channels
SOPs
1. SOP of responsibilityof Q.A in rejection.
2.
SOP for handlingreturned/ rejected goods.
3.
SOP for reprocess ofAPI or Intermediate
4.
SOP for calibrationof Instruments in Production and Quality Control.
5.
SOP for Procedurechange control.
6.
SOP on SOP in a
Pharmaceutical Industry.
7.
SOP for changing an
SOP.
8.
SOP of sanitation in
pharmaceutical industry.
9.
SOP of weekly
cleaning.
10.
SOP of monthly
maintenance or cleaning.
11.
SOP of change room.
12.
SOP of Dettol
preparation.
13.
SOP of hand wash.
14.
SOP for sampling
& release of in-process samples.
15.
SOP for evaluation of
analyst’s performance.
16.
SOP for preparation
of rejection note.
17.
SOP for destruction
of rejected materials.
18.
SOP for destruction
of control samples (raw material & finished product).
19. SOP for destroying the in-process, finished product and RM samples timely
after testing.
20.
SOP of entry
procedure for workers.
21.
SOP of exit procedure
for workers.
22.
SOP of entry
procedure for executives
23.
SOP of exit procedure
for executives
24.
SOP of entry
procedure for visitors.
25.
SOP of exit procedure
for visitors.
26.
SOP of entry
procedure in microbiology section.
27.
SOP of exit procedure
in microbiology section.
28. SOP for installation, operational and performance qualification of
Equipment / Instruments
29.
SOP for Qualification
of facility/ Equipments/ Systems.
30.
SOP for issue, entry,
review & control of batch manufacturing records.
31.
SOP for batch
re-processing
32.
SOP of Role of Q.A
33.
SOP for allocating
document protocol number for instrument qualification.
34.
SOP for allocating
identification number to instruments / equipments.
35. SOP for security register for incoming material (RM/PM)