Professional Documents
Culture Documents
Title:
Product Master Formula
SMP
Subject:
Standard Manufacturing Procedure (SMP)
Product:
Ciprofloxacin 200mg/100ml IV Infusion
Revision No.: 0
Date: 01-05-2009
Drug
Product Code
Batch #
Batch Size
Pack Size
Page #
Registrat
420 Litres
ion #
CPI
CPI
4000 Vials
1s X 100ml
Page 1 of 1
Shelf Life
Mfg. Date
Exp. Date
Expected Batch
Yield
95 105%
2 Years
Prepared By
Reviewed By
Approved By
Authorized By
Manager P & D
Manager Production
Manager QA
All activities are performed under the direct supervision of qualified person.
Wear Sterile Specified Uniforms and surgical gloves during all manufacturing and filling activities.
Check all the equipments / Utensils for proper cleanliness.
Check the Graphs of Sterilizers or PLC system graphs to verify the sterilization and pressure differential.
Check the temperature.
Check all the pipes, joints & filters for proper fitting.
Expose the settle plates during filling for 2 hours.
Check Q.C. approval before start of filling.
9. Ensure Line Clearance as per Line Clearance Certificate during all Production activities as per SOP08-QA-004.
10.
Carry out In-process Checks as per SOP-08-QA-005 & record it in Line Inspection Sheet.
11.
Always take out the terminally sterilized vials from ampoule sterilizer after sterilization.
WASHING
Sr. #
PROCEDURE STEPS
Operator
Pharmacist
IPQA
Date
Title:
Product Master Formula
SMP
Subject:
Standard Manufacturing Procedure (SMP)
Product:
Ciprofloxacin 200mg/100ml IV Infusion
Revision No.: 0
Date: 01-05-2009
Drug
Product Code
Batch #
Batch Size
Pack Size
Page #
Registrat
420 Litres
ion #
CPI
CPI
4000 Vials
1s X 100ml
Page 2 of 1
Shelf Life
Mfg. Date
Exp. Date
2 Years
Expected Batch
Yield
95 105%
STERILIZATION
Sr. #
PROCEDURE STEPS
Operator
Pharmacist
IPQA
Date
Operator
Pharmacist
IPQA
Date
005.
Machine:
Ampoules Sterilizer
COMPOUNDING
PROCEDURE STEPS
approval.
8. Take (70% of total volume) Water for Injection in
compounding vessel and nitrogenate it for 10-15 minutes.
kg at step
9. Add & dissolve Dextrose Anhydrous
# 8 until clear solution is Obtained.
10. Add Ciprofloxacin powder
kg at Step # 9 and
Title:
Product Master Formula
SMP
Subject:
Standard Manufacturing Procedure (SMP)
Product:
Ciprofloxacin 200mg/100ml IV Infusion
Revision No.: 0
Date: 01-05-2009
Drug
Product Code
Batch #
Batch Size
Pack Size
Page #
Registrat
420 Litres
ion #
CPI
CPI
4000 Vials
1s X 100ml
Page 3 of 1
Shelf Life
Mfg. Date
Exp. Date
Expected Batch
Yield
95 105%
2 Years
12.
pH Range
3.5 4.6
Target pH
4.05
Actual pH
ml
ml
D.
Theoretical Volume
Actual Volume
420
Litres
Litres
Sr. #
PROCEDURE STEPS
Operator
Pharmacist
IPQA
Date
Operator
Pharmacist
IPQA
Date
FILTRATION
PROCEDURE STEPS
Title:
Product Master Formula
SMP
Subject:
Standard Manufacturing Procedure (SMP)
Product:
Ciprofloxacin 200mg/100ml IV Infusion
Revision No.: 0
Date: 01-05-2009
Drug
Product Code
Batch #
Batch Size
Pack Size
Page #
Registrat
420 Litres
ion #
CPI
CPI
4000 Vials
1s X 100ml
Page 4 of 1
Shelf Life
Mfg. Date
Exp. Date
2 Years
Expected Batch
Yield
95 105%
then repeat the filtration with new filter (as and when
required).
4. Connect the silicon tubing with sterilized stainless steel
holding vessel in vial filling room as per SOP-04-016.
After Quality Control Release, filter the solution by
Nitrogen Pressurizing fibre-glass pre-filter and membrane
final filter (0.2 Micron or 142 mm) & transfer the filtered
5.
F.
Sr. #
Filtration Time
Operator
Pharmacist
IPQA
Date
Operator
Pharmacist
IPQA
Date
G.
Sr. #
105 ml
100 ml
110 ml
TERMINAL STERILIZATION
STAGES / STEPS
Title:
Product Master Formula
SMP
Subject:
Standard Manufacturing Procedure (SMP)
Product:
Ciprofloxacin 200mg/100ml IV Infusion
Revision No.: 0
Date: 01-05-2009
Drug
Product Code
Batch #
Batch Size
Pack Size
Page #
Registrat
420 Litres
ion #
CPI
CPI
4000 Vials
1s X 100ml
Page 5 of 1
Shelf Life
Mfg. Date
Exp. Date
2 Years
Expected Batch
Yield
95 105%
Sr. #
STAGES / STEPS
Operator
Pharmacist
IPQA
Date
Operator
Pharmacist
IPQA
Date
Operator
Pharmacist
IPQA
Date
Operator
Pharmacist
IPQA
Date
LEAKAGE TEST
Sr. #
STAGES / STEPS
Perform the vacuum leakage test on filled vials in
Ampoule Sterilizer (Inv. Code #: 04-AS-52) using
1.
J.
NLT 80 KPa
Time
OPTICAL INSPECTION
Sr. #
STAGES / STEPS
Carry out the optical inspection (Manual) of every vial for
1.
Title:
Product Master Formula
SMP
Subject:
Standard Manufacturing Procedure (SMP)
Product:
Ciprofloxacin 200mg/100ml IV Infusion
Revision No.: 0
Date: 01-05-2009
Drug
Product Code
Batch #
Batch Size
Pack Size
Page #
Registrat
420 Litres
ion #
CPI
CPI
4000 Vials
1s X 100ml
Page 6 of 1
Shelf Life
Mfg. Date
Exp. Date
Expected Batch
Yield
95 105%
2 Years
CODING
Sr. #
1.
STAGES / STEPS
Operator
Pharmacist
IPQA
Date
Operator
Pharmacist
IPQA
Date
Pharmacist
IPQA
Date
2.
per SOP-04-015.
3. QA Department will paste a Green Release Sticker on
Product Label after review of Batch History Record.
M.
PACKAGING
Sr. #
STAGES / STEPS
STAGES / STEPS
1.
o
Actual Yield
= __________________________
Operator
Title:
Product Master Formula
SMP
Subject:
Standard Manufacturing Procedure (SMP)
Product:
Ciprofloxacin 200mg/100ml IV Infusion
Revision No.: 0
Date: 01-05-2009
Drug
Product Code
Batch #
Batch Size
Pack Size
Page #
Registrat
420 Litres
ion #
CPI
CPI
4000 Vials
1s X 100ml
Page 7 of 1
Shelf Life
Mfg. Date
Exp. Date
2 Years
o
__________________________________________
__________________________________________
Expected Batch
Yield
95 105%
Detail of Deviation
Operator
Pharmacist
IPQA
Date
1.
2.
3.
Officer Production
Manager P&D
Manager QA