Sample MFR

PHARMACEUTICAL GUIDELINES Page 1 of 17
Address - XXX
MASTER FORMULA RECORD
PRODUCT: XYZ Tablets M.F.R. No. : ABC /TAB/MFR/001

(Calcium Carbonate and Zinc Sulfate Tablets)
Batch size: 1,00,000 Tablets Revision No./ Date : 01/05.06.2018
Composition Each film coated tablet contains:

Calcium Carbonate
Equivalent to elemental Calcium ……xx mg
Zinc Sulfate Monohydrate USP
Equivalent to elemental Zinc…….…… xx mg
Excipients……………………………….q.s.
Colour: Titanium Dioxide IP
Appropriate overages of Vitamin added.
Description A white to off white coloured, film coated oval shaped plain tablets.
Mfg. license No. XXXXXXXXXX
Storage Condition Store in a cool, dry & dark place.
Marketed by M/s. ABC Pharmaceuticals Limited
Shelf Life 24 months or expiry of active ingredient whichever is less.
Packing Style Sale’s Pack :

 Pack 1 blister of 10 tablets along with a leaflet in Monocarton.
 Pack 10 such Monocartons in an Outer Carton.
 Pack 12 such Outer Cartons in a 3 ply corrugated Box along
with a packing slip.
Physician Sample Pack :
 Pack one blister of 2 tablets along with a leaflet in a Carton.
 Pack 30 such Cartons in a plain inner box
 Pack 30 such inner boxes in a 3 ply printed corrugated Box
along with a packing slip.
This Document Supersedes NA
Reason for Change NA
PREPARED BY APPROVED BY AUTHORISED BY
R&D R & D Head UNIT Head Q.A. Head
Date: Date: Date: Date:
© www.pharmaguideline.com info@pharmaguideline.com
Address - XXX

HISTORY OF CHANGE
Sr. Revision No./Date This Document Reason for Change

No. supersedes
1. 00/01.07.2016 N.A. First Time Manufacturing at Location
2. 01/05.06.2018 00/01.07.2016 Change in Manufacturing Procedure
Remark: -
 Master Formula Record will be revised if there is change in Batch Size, Formula,
Process, Primary Packing Material & any other critical change.
Address - XXX

GENERAL INSTRUCTION
HEALTH & SAFETY PRECAUTIONS:

 Protect the respiratory organs from active substance. Use nose mask, gloves & safety goggles
 Store the blend & tablets in well closed containers lined with double, black polythene bags.
 Follow personal hygienic requirements.
 Protect the respiratory organs from active substance. Use nose mask, gloves & safety goggles
NOTES:
1. Manufacturing is to be carried out as per requirements of current GMP.
2. Use clean and dry S.S. Equipments at all stages of manufacturing.
3. Carry out sifting and milling operations near dust extraction.
4. All equipments and machineries must be adequately guarded and earthed. The operators must use
proper safety equipments like hand gloves, nose masks, ear muffs, etc. during all operations.
5. Ensure that general cleaning & utensils cleaning are carried out as per respective S.C.P. &
check for cleanliness before use.
6. Ensure that RMG, FBD, Octagonal Blender, Multi mill,Cad mill Vibratary sifter, S.S. Sieves, S.S.
Screens, Compression machine, Coating Pan & Blister Packing Machine etc. are cleaned as per
respective S.C.P.
7. Before weighing operations, check cleanlines of balances as per S.C.P.
8. Destroy all rejected blend & tablets by putting in a container of water after recording the weights.
9. All the ingredients must have been passed by Q.C. Dept., prior to use and must be within retest date.
10. Operations like sifting, mixing, blending, compression & coating must be carried out in
controlled environment such as:
a] Relative Humidity: NMT 50 % b] Temperature: NMT 25 °C.
Address - XXX

LIST OF MACHINERY & EQUIPMENT
Sr. Machinery/ equipment Capacity Equipment. ID

No
1. Balance 150 Kg
ABC/EQ/TAB/001
2. Sifter (with SS Seives 30 “
20,40, 60,80) ABC/EQ/TAB/002
3. RMG 600 Liter

ABC/EQ/TAB/003
4. Stirrer --
ABC/EQ/TAB/004
5. Octagonal Blender 1000 Liter
ABC/EQ/TAB/005
6. Multimill (with SS Screen
ABC/EQ/TAB/006
0.5mm )
7. FBD 200 kg
ABC/EQ/TAB/007
8. Compression Machine 27 station
ABC/EQ/TAB/008
9. Stirrer- Propeller ----
ABC/EQ/TAB/009
10. Neocota 60“
ABC/EQ/TAB/010
11. Weighing Balance --- ABC/EQ/TAB/011
12. Blister Packing machine 60 strokes/minute
ABC/EQ/TAB/012
13. Deblistering Machine ---
ABC/EQ/TAB/013
14. Conveyor Belt ---
ABC/EQ/TAB/014
15. Leak test apparatus ---
ABC/EQ/QCD/015
16. Carton Weighing Balance 60.00 kg
ABC/EQ/TAB/016
17. Box Weighing Balance 60.00 kg
ABC/EQ/TAB/017
Address - XXX

RAW MATERIALS INDENT SHEET
Sr. Ingredients Material Qty./Tab. Qty For Batch

No. Code No. [mg] [Kg]
FOR CORE
1 Calcium Carbonate* xxxxxxx xx mg Considering 21.5 %

[equivalent to elemental elemental calcium
Calcium 250 mg] Qty. = xx Kg.
2 Zinc Sulfate Monohydrate USP xxxxxxx xx mg A1
[equivalent to Elemental [Considering 100 %
zinc 7.5 mg] assay Qty = xx Kg.]
3 Starch IP (Maize) [For dry mix] xxxxxxx q.s. B1
[Approx. [Approx. Qty.
xxxxx mg] xxxxx Kg.]
4 Sodium Starch Glycolate IP xxxxxxx 20 mg 2.000
(Primogel)
5 Purified water IP xxxxxxx 600 mg 60.000
* If the assay of elemental calcium in Calcium Carbonate is between 21% to 23.5 % consider the
theoretical quantity.
A1: Calculate the quantity of Zinc Sulfate Monohydrate USP if assay is below 100% on as is basis. If the
assay is 100% or above consider the theoretical quantity.
B1: Compensate the quantity of Zinc Sulfate Monohydrate USP with Starch IP.
Note: Quantity of Zinc Sulfate Monohydrate USP & Starch IP to be considered upto 3 decimal places.
Address - XXX

RAW MATERIALS INDENT SHEET

Sr. Ingredients Material Qty /Tab Qty For Batch
No Code No. [mg] [Kg]
LUBRICANTS
6 Starch IP (Maize) xxxxxxxx q.s. D

[For lubrication] [Approx. [Approx. Qty./Batch
xxxx mg] xxxx Kg.]
7 Colloidal Silicon Dioxide IP xxxxxxxx 10.000 2.000

(Cabosil)
8 Magnesium Stearate IP xxxxxxxx 10.000 2.000
COMPRESSION WEIGHT : xxxx mg / Tablet

FILM COATING*
1 Opadry OY-IN 58910 (white) xxxxxxxx xxxxx xxxxx
2 Isopropyl Alcohol IP @ xxxxxxxx xxxxx xxxxx
3 Methylene Chloride IP @ xxxxxxxx xxxxx xxxxx
*20% extra coating material added to compensate the loss during coating process.
Quantity of coating material to be revised after three validation batches.
@ Does not remain in final product.
Address - XXX

CALCULATION:
1] Qty. of Zinc Sulfate Monohydrate USP [A] = ______kg
2] Qty. of Starch IP (Maize) [For dry mix] [B] = ______kg
Note: Quantity of Zinc Sulfate Monohydrate USP & Starch IP to be considered up to 3 decimal
places.
Address - XXX

MANUFACTURING PROCESS SHEET

S.No. Operation
Note down granulation area No. used, previous product processed & Its B. No.
Check Area & plant clearance.
1.0 SIFTING: REFER SOP/SCP NO. : ABC/PR/006 & ABC/PRC/002
1.1 Check the integrity of the sieve before & after sifting of individual material.
1.2 Crush using multimill using 0.5 mm screen, impact forward & Sift separately through 40 # sieve,
Calcium Carbonate ……………. ….. …XXX Kg
Sodium Starch Glycolate IP (Primogel) …… 2.000 Kg
1.3 Sift separately through 60 # sieve
Zinc Sulfate Monohydrate USP………………XXX Kg [A1]
Starch IP[Maize] [For dry mix]………………1.964 [B1]
2.0 DRY MIXING:REFER SOP/SCP NO.: ABC/PR/016 & ABC/PRC/020
2.1 Transfer content of step 1.0 in to RMG & mix for 20 minutes. at slow speed with mixer on &
chopper off.
Note: Withdraw the sample for release & Hold time study
3.0 Transfer Purified water IP …………. 60.000 Kg into a clean S.S. vessel.
4.0 GRANULATION: REFER SOP/SCP No. : ABC/PR/016 & ABC/PRC/020

4.1 Add the Purified water IP of stage 3.0 in to RMG through paste window.
4.2 Continue mixing at slow speed till the granulation end point is achieved with agitator and chopper
“ON” (to get required consistency dough mass). Record Actual mixing time & note down ammeter
reading.
4.3 If required excess Purified water IP can be added in incremental Lots of 1.0 L to obtain required
consistency dough mass. Record the quantity of extra Purified Water IP used. Record the
additional wet mixing time. Record Ammeter reading.
Address - XXX


S.No Operation
5.0 WET MASS MILLING: Refer SOP/SCP No. XXXXXX
5.1 Check the integrity of the screen before & after milling.
5.2 Pass wet mass at stage 4.0 through multimill using 10 mm screen at medium speed with knives
forward direction
5.3 Transfer the wet mass [Granules] to FBD bowl through the discharge port. Keep the agitator at
slow speed & chopper in OFF position during transfer of the wet mass.
6.0 DRYING: REFER SOP/SCP NO. : XXXXXX
6.1 Dry the wet mass at stage 5.0 in a fluidized bed drier at ambient temperature for 15 minutes &
then dry the mass at inlet temp. 55+ 5°C. Rake over the granules intermittently so that all the
material in contact with the screen is turned. The drying is adequate when the LOD reaches 6.5
to 8.5 % w/w. Note down inlet temperature, Outlet temperature & total time taken for drying.
6.2 Check the LOD [Limit : 6.5 – 8.5 % w/w at 105°C].
7.0 SIZING: REFER SOP/SCP NO. : XXXXXX
7.1 Check the integrity of the screen before & after milling.
7.2 Sift the dried granules of step 6.0 through 20 mesh. Mill the oversize granules through multimill
using 2.0. mm screen at knives forward direction at medium speed. Again sift the granules
through 20 mesh.
7.3 Note down weight of sized granules.
Theoretical Wt. XXX Kg
Address - XXX


S.No Operation
9.0 LUBRICATION: REFER SOP/SCP NO. : XXXXXX
9.1 Check the integrity of the sieve before & after sifting of individual material.
9.2 Collect Approx. 3.0 Kg fines of sized granules below 40 # sieve & mix with,
Colloidal Silicon Dioxide IP[Cabosil]………. 2.000 kg,
in a polybag & then sift through 40 # sieve.
9.3 Sift through 60 # sieve
Magnesium Stearate IP ……………………………… 2.000 Kg
9.4 Sift through 80 # sieve
Starch IP[Maize] [For lubrication]………………………..1.600 [D],
Transfer sifted granules of Lot I (step 7.0 ),Lot II (step 8.0 ), sifted materials of step 9.2 and
9.5 Step 9.4 to Octagonal blender & mix for 20 minutes at RPM 8.
Transfer the contents of 9.3 to Octagonal blender at step 8.0 & mix for 2 minutes at RPM 8.
9.6 Note: Inform QC to withdraw the sample for release & Hold time study
Unload & collect the lubricated blend in double black polythene bag & record Wt.
9.7 Theoretical Wt. XXX Kg. Standard yield will be decided after three validation batches.
10.0 COMPRESSION: Refer SOP/SCP No.: XXXXXX
10.1 Set the compression machine as per the SOP of the machine using “D” type 22 x 9.5 mm oval
shaped plain punch.
10.2 Check the complete rotation of the turret by turning the hand wheel followed by electric
operation. Feed the blend & set the machine as per parameters given on page No. 13,
accordingly record the parameters in BMR.
10.3 Record the yield and store the tablets in double polythene bags with proper label.
Note: Inform QC to withdraw the sample for release & Hold time study
Address - XXX

COMPRESSION PARAMETERS START UP & INPROCESS

Sr. Parameter Standard No of Tablets In-Process
No Frequency
1 Temperature NMT 25°C. -- 2 hours
2 Relative humidity NMT 50% -- 2 hours
3 Hydraulic Pressure 27 To be decided -- --
Station double rotary
tablet press machine
4 Machine speed To be established -- --
5 Punch size 22 x 9.5 mm All stations --
6 Upper punch “D” type 22 x 9.5 mm oval shaped All stations --
plain punches.
7 Lower punch “D” type 22 x 9.5 mm oval shaped All stations --
plain punches.
8 Die “D” type round die -- --
9 Description A White to off - white colored oval All station 2 hours
shaped biconvex uncoated tablet
with speckled surface.
10 Average- length 21.8 – 22.2 mm 6 / Individual 2 hours
11 Average -width 9.4 – 9.6 mm 6 / Individual 2 hours
12 Thickness 6.7 to 7.1 mm 6 / Individual 30 Min.
13 Hardness 10 to 20 Kg/cm2 6 / Individual 30 Min.
14 Disintegration time NMT 15 minutes 6 / Composite 2 hours
15 Friability NMT 1 % w/w 10/ Composite 2 hours
16 Weight of 20 tabs. xx.xx g ± 3% (xx.xx to xx.xx g) 20/ Composite 15 Min
17 Uniformity of weight NMT 2 tablets in 20 deviate from 20/ Composite
the average weight by more than
2 Hour
5% No tablet deviates from the
average weight by more than 10 %.
Average weight of
18 xx.xx mg ± 3% 20/ Composite 15 Min
tablets
19 Lower weight assembly Should be satisfactory --- ---
Feed frame alignment
20 Should be satisfactory --- ---
and adjustment.
Compression machine
21 --- --- ---
27 station
Address - XXX

S.No. Operation
11.0 PREPARATION OF COATING DISPERSION : Refer XXXXXX
11.1 Transfer, Isopropyl Alcohol IP………..….xxxx Kg. In a clean SS vessel.
11.2 Add & Disperse to step 11.1, Opadry white OY –In-58910.….xxxx Kg.
11.3 Add to step 11.2, Methylene Chloride IP ….xxxx Kg. Stir for 45 minutes at RPM 200 to 1000, till
uniform dispersion is formed. Filter the dispersion through 100 # nylon cloth. Note down the stirrer
RPM in BMR.
11.4 Note: Nylon cloth should be lint free & single use
Note: Withdraw the sample for release & Hold time study
11.5 Use the coating dispersion freshly prepared.
12.0 COATING PROCESS: Refer SOP/SCP No.: XXXXXX

12.1 Load the dedusted & inspected core tablets into a clean, dry S.S. coating pan
12.2 Set the Neocota as per standard parameters given on page no.14. Record the observations in BMR.
12.3 Before starting the coating maintain the bed temperature to 38 + 3°C
12.4 Apply the film coating solution to the tablets using a clean spray gun assembly to get 3.0 to 3.2 %
weight gain (Target weight gain: 3.0%)
12.5 Coating dispersion to be stirred continuously throughout the coating process at RPM 200 to 1000.
Note down the stirrer RPM in BMR.
12.6 Check the tablets intermittently for twining, shade variation during film coating process.
12.7 Record the inlet & outlet Temperature at every 20-min. & record the same in BMR.
12.8 Before coating & After coating check the parameters & record the observations in BMR.
12.9 Check & record net weight of coated tablet. Keep the batch tightly closed with proper labels.
12.10 Before taking tablets for packing, Inspect the tablets for appearance, black spots, Broken & chipped
tablet. Segregate the rejection for destruction. Note down the weight in BMR. Store the tablets in
double Polythene bags.
12.11 Inform QC to withdraw the sample for release & Hold time study
If coating process to be stopped in between before completion of process dry the tablets in a pan at temp.
300C for ½ hrs and record the time.
Address - XXX

STANDARD COATING PARAMETRS

Parameter Standard
Net weight of the core tablets XXX Kg
Coating Pan Type 60” Neocota - Perforated
Spray Gun Type To be recorded
Spray Gun Nozzle Diameter 1.0 mm
Spray Gun Air Nozzle Diameter 1.0 mm
No. of Spray Guns To be recorded
Gun to Gun distance To be recorded
Gun to Tablet Bed distance To be recorded
Pan Load To be recorded
Exhaust Blower To be recorded
Damper To be recorded
Coating Pan RPM To be recorded
Atomizing Air Pressure To be recorded
Spray Rate To be recorded
Inlet Air Temp. To be recorded
Tablet Bed Temp. To be recorded
INPROCESS CHECKS DURING COATING

Parameter Limits
Appearance A White to off -white coloured oval biconvex film coated plain tablet.
Average Weight of 20 coated xx.xx – xx.xx g
tablets
Uniformity of weight NMT 2 tablets in 20 deviate from the average weight by more than 5%
No tablet deviates from the average weight by more than 10%
Average Length 21.8 – 22.20 mm
Average Width 9.40 – 9.60 mm
Thickness of 6 coated tablets 6.9 to 7.3 mm
Hardness of 6 coated tablets 12 - 22 Kg/cm2
Disintegration time of 6 coated Not more than 30 minutes

tablets
Address - XXX

PACKING MATERIALS DATA SHEET
Sr. Name of the Material Materials Code Theoretical

No. Nos. Qty. Reqd.
SALE’S PACK
1. Foil Printed XXXXX 176X0.025 mm xxxxxx xxxx Kg
2. Film PVC/PVDC Clear 180 mm 250/60 GSM xxxxxx xxxx Kg
3. Monocarton XXXXXX 1 x 10 T xxxxxx xxxx Nos
4. Leaflet xxxxxx xxxx Nos
5. Carton Outer XXXXX 10 x 1 x 10 T xxxxxx xxxx Nos
6. BOX 5 PLY XXXXX 294X198X220 xxxxxx xxxx Nos
7. Packing Slip xxxxxx xxxxNos
8 Tape BOPP Printed XXXXX 60 mm x 65 mtr xxxxxx x Rolls
NOTE: SAP codes of the packing materials will be controlled separately through
‘SAP Codes of packing materials’ page succeeding to BOM page of BPR.
So BOM page will not have SAP codes.
Address - XXX

INSTRUCTIONS FOR PACKING

S.No. Operation
1 Check the blister packing machine & the area for cleanliness.
2 Check whether all the packing materials are Released by Q.C.
3 Check that the batch is released for packing by Q.C.
4 Check that the blister packing machine is set with corresponding change parts & the assembly for
subject product tablets.
5 Fix stereos having batch details on printing roller. Fix 176 mm Printed Aluminium Foil for sale pack
on the foil roller & print the details on by squeezing the foil manually through printing rollers. Check
clarity of printing. Get the overprinting matter approved by Pharmacist & Q.A.
6 Fix 180 mm film PVC/PVDC clear 250/60 GSM plain foil for sale pack on the other roller. Set the
temperature of blister forming & sealing roller as decided after validation of Packing blister change
part.
7 Adjust the cutter to give blister of 10 tablets each for sale pack. Take out empty blisters. Check
knurling; as well as printing clarity on individual blisters. Ensure that each blister contains all the
batch details.
8 Load the tablets into the hopper & pass into the chute by using a vibrator. Start the m/c by inching &
adjust the alignment of the chute & the sealing roller if required. Adjust the cutter if required, to cut
proper blisters.
9 Take out a no. of blisters from the machine that represent complete coverage of sealing area and
perform leak test as per SOP No.: SOP: No: ABC/PR/028
The blisters should pass the leak test [Limit: Should be Nil].
10 Start the machine when set to give blisters of above specification. Get the line clearance from Q.A.
& start packing.
11 Check all the blisters for physical defects such as improper sealing, cut- pockets, empty pockets,
uneven or distorted printing, etc.
12.0 SALE’S PACK
12.1 Pack one blister of 10 tablets along with a leaflet in Monocarton bearing all the relevant batch
details. The matter to be overprinted should be approved by Pharmacist and Q.A.
12.2 Pack 10 such Monocartons in an Outer carton.
12.3 Pack 12 such Outer cartons in a 5 ply corrugated Box, along with a packing slip. [Arrange 2 Outer
cartons in length of Box, 2 Outer cartons in width of Box & 3 Outer cartons in height of Box i.e. 2 x 2
x 3 = 12 Outer Cartons/Box].
12.4 Stencil the Box with proper batch details. The matter to be stenciled should be approved by
pharmacist & Q.A. Seal the Box with BOPP tape Printed with XXXXX logo in ‘C’ type.
12.5 Number the Boxes serially while packing. Note & record the yield at the end of packing. Intimate
Q.A. for finished product sampling as applicable.
Address - XXX

INSTRUCTIONS FOR PACKING [PS PACK]

S.No. Operation
1 Check the blister packing machine & the area for cleanliness.
2 Check whether all the packing materials are Released by Q.C.
3 Check that the batch is released for packing by Q.C.
4 Check that the blister packing machine is set with corresponding change parts & the assembly for
subject product tablets.
5 Fix stereos having batch details on printing roller. Fix 162 mm Printed Aluminium Foil for sale pack
on the foil roller & print the details on by squeezing the foil manually through printing rollers. Check
clarity of printing. Get the overprinting matter approved by Pharmacist & Q.A.
6 Fix 166 mm film PVC/PVDC clear 250/60 GSM plain foil for physician’s sample pack on the other
roller. Set the temperature of blister forming & sealing roller as decided after validation of Packing
blister change part.
7 Adjust the cutter to give blister of 2 tablets each for PS pack. Take out empty blisters. Check
knurling; as well as printing clarity on individual blisters. Ensure that each blister contains all the
batch details.
8 Load the tablets into the hopper & pass into the chute by using a vibrator. Start the m/c by inching &
adjust the alignment of the chute & the sealing roller if required. Adjust the cutter if required, to cut
proper blisters.
9 Take out a no. of blisters from the machine that represent complete coverage of sealing area and
perform leak test SOP No.: SOP: No: ABC/PR/028.
10 The blisters should pass the leak test [Limit: Should be Nil].
Start the machine when set to give blisters of above specification. Get the line clearance from Q.A.
& start packing.
11 Check all the blisters for physical defects such as improper sealing, cut- pockets, empty pockets,
uneven or distorted printing, etc.
12.0 PS PACK
12.1 Pack one blister of 2 tablets along with a leaflet in a Carton bearing all the relevant batch details. The
matter to be overprinted should be approved by Pharmacist and Q.A.
12.2 Pack 30 such Cartons in a 3 ply Inner box. [Arrange 15 cartons length of Inner Box, 2 cartons in width of
Inner Box & 1 carton in height of Inner Box i.e. 15 x 2 x1 = 30 cartons/ Inner boxes]. Stamp/ stencil the
inner box with proper batch details. The matter to be stamped/ stencilled should be approved by
pharmacist & Q.A.
12.3 Pack 30 such Inner boxes in a 5 ply outer Box along with a packing slip. [Arrange 2 Inner boxes in length
of Outer Box, 3 Inner boxes in width of Outer Box & 5 Inner boxes in height of Outer Box i.e.2 x 3 x 5 =
30 Inner boxes/ Outer Box].
12.4 Stencil the Box with proper batch details. The matter to be stenciled should be approved by pharmacist &
Q.A. Seal the Box with Printed BOPP tape in ‘C type.
12.5 Number the Boxes serially while packing. Note & record the yield at the end of packing. Intimate Q.A. for
finished product sampling as applicable.
Address - XXX

YIELD STATEMENT *
PERMISSIBLE YIELD [%]

SR. STAGE OF INPUT STD. YIELD LOWER HIGHER
NO. OPERATION A [%]
1. Sized granules XXX Kg
2. Lubricated Blend XXX Kg
Compressed 1,00,000 tablets

3.
Tablets.
4. Coated Tablets 1,00,000 tablets
5. Packed tablets 1,00,000 tablets
*Yield will be decided after completion of 3 validation batches.

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PHARMACEUTICAL GUIDELINES Page 1 of 17

PRODUCT: XYZ Tablets M.F.R. No. : ABC /TAB/MFR/001

Composition Each film coated tablet contains:

Mfg. license No. XXXXXXXXXX

Storage Condition Store in a cool, dry & dark place.

Marketed by M/s. ABC Pharmaceuticals Limited

Shelf Life 24 months or expiry of active ingredient whichever is less.

Packing Style Sale’s Pack :

Reason for Change NA

PREPARED BY APPROVED BY AUTHORISED BY

R&D R & D Head UNIT Head Q.A. Head

Date: Date: Date: Date:

PRODUCT: XYZ Tablets M.F.R. No. : ABC /TAB/MFR/001

Sr. Revision No./Date This Document Reason for Change

1. 00/01.07.2016 N.A. First Time Manufacturing at Location

2. 01/05.06.2018 00/01.07.2016 Change in Manufacturing Procedure

PRODUCT: XYZ Tablets M.F.R. No. : ABC /TAB/MFR/001

HEALTH & SAFETY PRECAUTIONS:

PRODUCT: XYZ Tablets M.F.R. No. : ABC /TAB/MFR/001

LIST OF MACHINERY & EQUIPMENT

Sr. Machinery/ equipment Capacity Equipment. ID

3. RMG 600 Liter

PRODUCT: XYZ Tablets M.F.R. No. : ABC /TAB/MFR/001

RAW MATERIALS INDENT SHEET

Sr. Ingredients Material Qty./Tab. Qty For Batch

1 Calcium Carbonate* xxxxxxx xx mg Considering 21.5 %

PRODUCT: XYZ Tablets M.F.R. No. : ABC /TAB/MFR/001

RAW MATERIALS INDENT SHEET

6 Starch IP (Maize) xxxxxxxx q.s. D

7 Colloidal Silicon Dioxide IP xxxxxxxx 10.000 2.000

8 Magnesium Stearate IP xxxxxxxx 10.000 2.000

COMPRESSION WEIGHT : xxxx mg / Tablet

@ Does not remain in final product.

PRODUCT: XYZ Tablets M.F.R. No. : ABC /TAB/MFR/001

1] Qty. of Zinc Sulfate Monohydrate USP [A] = ______kg

2] Qty. of Starch IP (Maize) [For dry mix] [B] = ______kg

PRODUCT: XYZ Tablets M.F.R. No. : ABC /TAB/MFR/001

MANUFACTURING PROCESS SHEET

4.0 GRANULATION: REFER SOP/SCP No. : ABC/PR/016 & ABC/PRC/020

PRODUCT: XYZ Tablets M.F.R. No. : ABC /TAB/MFR/001

MANUFACTURING PROCESS SHEET

PRODUCT: XYZ Tablets M.F.R. No. : ABC /TAB/MFR/001

MANUFACTURING PROCESS SHEET

PRODUCT: XYZ Tablets M.F.R. No. : ABC /TAB/MFR/001

COMPRESSION PARAMETERS START UP & INPROCESS

PRODUCT: XYZ Tablets M.F.R. No. : ABC /TAB/MFR/001

MANUFACTURING PROCESS SHEET

12.0 COATING PROCESS: Refer SOP/SCP No.: XXXXXX

PRODUCT: XYZ Tablets M.F.R. No. : ABC /TAB/MFR/001

STANDARD COATING PARAMETRS

Net weight of the core tablets XXX Kg

Coating Pan Type 60” Neocota - Perforated

Spray Gun Type To be recorded

Spray Gun Nozzle Diameter 1.0 mm

Spray Gun Air Nozzle Diameter 1.0 mm

No. of Spray Guns To be recorded

Gun to Gun distance To be recorded

Gun to Tablet Bed distance To be recorded

Pan Load To be recorded