Company Name

Raya pharmaceuticals Co. Ltd MF# MF-004

Manufacturing\ processing Rev # 1

instructions and records for Implementation
Title 22/4/2019
CATAFLAM® tablet /effective Date
(50mg /900mg) Page # 1 of 8

Product Name: Cataflam® (diclofenac potassium immediate-release tablets))

Department Solid production Product Code NDC0078
Dosage Form/ Tablet/ 50mg Shelf Life 36 months
strength 3 years
Batch Size 500,000 Weight 900mg

The following materials are used

Code Component function Qty/unit Qty/Batch Ref
(mg) (kg)
001 Diclofenac potassium API 50mg 25 kg DMF
002 Gluceryl behenate or Methyl Coating agent 0.2mg 0.1kg NF
cellulose
003 Saccharin soduim Sweeting agent 4mg 2 kg USP
004 Anise flavor Flavoring agent 100mg 50 kg In-house
005 Potassium bicarbonate Alkalizing agent, 22mg 11 kg USP
therapeutic agent
006 Mint flavor Flavoring agent 50mg 25kg In-house
007 Asprtame Sweeting agent 10mg 5 kg NF
008 Mannitol 50mg 25 kg USP
009 Sodium carboxymethylstarch 2.5 mg 1.25kg USP
010 Total Saccbarose its use 400.2mg 200.1kg
011 Sodium laurylsulfate Emulsfying agent and 0.1mg 0.05kg FDA
tablet lubricant
012 silica colloidal dioxide Diluent 10mg 5kg FDA
013 Magnesium stearate Lubricant 4.5mg 2.25kg FDA
014 povidone, granulation aid 1mg 0.5kg FDA
015 sodium starch glycolate Tablet disintegrant 2.5mg 1.25kg FDA
016 binder; thickening 10mg 5kg FDA
maize starch ((intragranular) agent.
017 binder; thickening 15mg 7.5kg FDA
maize starch ((extragranular) agent.
018 168mg 84kg USP
Sucrose

Prepared By mohammad Checked by Tareq Approved By Raya

Date 22/4/2019 Date 22/4/2019 Date 22/4/2019
 Company Name
Raya pharmaceuticals Co. Ltd MF# MF-004

Manufacturing\ processing Rev # 1

instructions and records for Implementation
Title 22/4/2019
CATAFLAM® tablet /effective Date
(50mg /900mg) Page # 2 of 8

Product Name: Cataflam® (diclofenac potassium immediate-release tablets))

Department Solid production Product Code NDC0078
Dosage Form/ Tablet/ 50mg Shelf Life 36 months
strength 3 years
Batch Size 500,000 Weight 900mg

The following machines are used

code Machines / Cleaning Operating Date Cleane Checked

equipment SOP SOP d by by
001 Electronic C001 O001
balance
002 Atlas tap density C002 O002
tester
003 Ohaus LOD C003 O003
tester
004 Flowability C004 O004
tester
005 stand and funnel - O005
006 Hardness tester C006 O006
007 Disintegration C007 O007
tester
008 Rotary Tablet C008 O008
Compression
machine
009 Fast speed mixer C009 O009
granulator
010 Sugar coating C010 O010
machine

Ste Instruction Equipment Star finish Operta signatur Chec signat

p# to be used: t ting by e k by ure

Prepared By mohammad Checked by Tareq Approved By Raya

Date 22/4/2019 Date 22/4/2019 Date 22/4/2019
 Company Name
Raya pharmaceuticals Co. Ltd MF# MF-004

Manufacturing\ processing Rev # 1

instructions and records for Implementation
Title 22/4/2019
CATAFLAM® tablet /effective Date
(50mg /900mg) Page # 3 of 8

Product Name: Cataflam® (diclofenac potassium immediate-release tablets))

Department Solid production Product Code NDC0078
Dosage Form/ Tablet/ 50mg Shelf Life 36 months
strength 3 years
Batch Size 500,000 Weight 900mg

1 Weighting Electronic
balance
1.1 Check the cleanliness of the
weighing area.
1.2 Check the cleaing of all
equipment and instrunent
which will use
1.3 Check all material
recquired and there label,
information, code and batch
number
1.4 Authorization to start
weighing of the batch.
1.5 Start weigh all materil in
weighing room under
required conditions in the
amounts specified above for
required batch quntity
2 Mixing and granulation Fast speed
mixer
granulator
2.1 Components 1, 2, 5, 6 and 7
in table 1 are mixed in a
Suitable mixer
2.2 the mixture so obtained is
wetted with 95% ethanol.
2.3 Granulation is carried out
with a 66 mm mesh
2.4 d the granu late is preferably
dried in current of air
2.5 Components 3, 4 and 8,
Prepared By mohammad Checked by Tareq Approved By Raya
Date 22/4/2019 Date 22/4/2019 Date 22/4/2019
 Company Name
Raya pharmaceuticals Co. Ltd MF# MF-004

Manufacturing\ processing Rev # 1

instructions and records for Implementation
Title 22/4/2019
CATAFLAM® tablet /effective Date
(50mg /900mg) Page # 4 of 8

Product Name: Cataflam® (diclofenac potassium immediate-release tablets))

Department Solid production Product Code NDC0078
Dosage Form/ Tablet/ 50mg Shelf Life 36 months
strength 3 years
Batch Size 500,000 Weight 900mg

which have already been

granulated using a mesh of
the same granulometry, are
then added
and the whole is mixed.
2.6 The mixture is then
introduced for coating by
filling packets or similar
containers.
3 Send sample for QC test
for granule
3.1 Bulk Density Cylinder
and
Electronic
balance
3.1.1 Put cylinder 100 ml on balance
3.1.2 Re-zero the balance then full the qranules in cylinder for 100 ml or top.
3.1.3 take the weight of 100ml of granules to calculate the bulk density

3.2 Tapped Density Atlas tap

density
tester
3.2.1 put cylinder in tap density machine.
3.2.2 start the machine for three time.
3.2.3 take the minimum volume to ccalculate tapped density.

3.3 loss on drying Ohaus LOD

test tester

3.3.1 take 0.5g sample of granules.

3.3.2 distribute the granules on the sample pan drying and use best-guess temperature.

Prepared By mohammad Checked by Tareq Approved By Raya

Date 22/4/2019 Date 22/4/2019 Date 22/4/2019
 Company Name
Raya pharmaceuticals Co. Ltd MF# MF-004

Manufacturing\ processing Rev # 1

instructions and records for Implementation
Title 22/4/2019
CATAFLAM® tablet /effective Date
(50mg /900mg) Page # 5 of 8

Product Name: Cataflam® (diclofenac potassium immediate-release tablets))

Department Solid production Product Code NDC0078
Dosage Form/ Tablet/ 50mg Shelf Life 36 months
strength 3 years
Batch Size 500,000 Weight 900mg

3.3.3 put the pan in moisture analyzer and start it.

3.3.4 take the reading when drying curve is fixed
3.4 Angle of stand and
funnel or
repose:
flowbility
tester
3.4.1 place the funnel on stand at height 4 cm from above the center of a piece of paper.
3.4.2 close the funnel by fingure then put granules in funnel.
3.4.3 remove the fingure to flow the granules.
3.4.4 take the dimeter of circle is formed to calculate the angle
3.4.5 retest for three time.

3.5 Sieve analysis Seive

analyzer
and
Electronic
balance
3.5.1 Weight empty sutible sieves and collection pan..
3.5.2 Arrange the seive from the smallest mesh number at the top to the largest at the bottom.
3.5.3 Weight 100g sample of granules and transfer it to the top sieve then cover with cap.
3.5.4 Agitate for 5 minutes at sutible speed.
3.5.5 Remove the seive and reweight.
3.5.6 If the weight of the powder remaining in any seive or bottom Pan more than 20% of total weight
add other seive and reoperate for anoother two minutes.
3.5.7 Take the new weight to calculate the weight variation.
3.6 Porosity Electronic
balance and
cylinder
3.6.1 put mixture of granules in cylinder and take the weight of granules.
3.6.2 prepare sutible (unsoluble for granules) oil then take its volume.

Prepared By mohammad Checked by Tareq Approved By Raya

Date 22/4/2019 Date 22/4/2019 Date 22/4/2019
 Company Name
Raya pharmaceuticals Co. Ltd MF# MF-004

Manufacturing\ processing Rev # 1

instructions and records for Implementation
Title 22/4/2019
CATAFLAM® tablet /effective Date
(50mg /900mg) Page # 6 of 8

Product Name: Cataflam® (diclofenac potassium immediate-release tablets))

Department Solid production Product Code NDC0078
Dosage Form/ Tablet/ 50mg Shelf Life 36 months
strength 3 years
Batch Size 500,000 Weight 900mg

3.6.3 add the oil for granules and take their final volume.
3.6.4 calculation the true density and porosity.
4 Tableting Tablet
Compressio
n machine
4.1 Cheak all QC
test and their
result.
4.2 Check the
cleanliness of
the tableting
area and
tableting
machine.
4.3 Calibration the
tablet machine
for required
weight and
hardness
4.4 Transfer
granules by
containers to
tablet machine
4.5 Start tableting
with make
adjuatment for
all parameter
and punches
4.6 Make in process QC test
4.6.1 Weight tablet: Electronic
Take continous balance
sample and

Prepared By mohammad Checked by Tareq Approved By Raya

Date 22/4/2019 Date 22/4/2019 Date 22/4/2019
 Company Name
Raya pharmaceuticals Co. Ltd MF# MF-004

Manufacturing\ processing Rev # 1

instructions and records for Implementation
Title 22/4/2019
CATAFLAM® tablet /effective Date
(50mg /900mg) Page # 7 of 8

Product Name: Cataflam® (diclofenac potassium immediate-release tablets))

Department Solid production Product Code NDC0078
Dosage Form/ Tablet/ 50mg Shelf Life 36 months
strength 3 years
Batch Size 500,000 Weight 900mg

weight for
sureing the
weight is sutible

4.6.2 Hardness: Hardness

Cheak the force tester
required to
breake a tablet
4.6.3 Friability Friability
tester
4.6.4 Disintegration Disintegratio
test n tester
4.6.5 Dissolution test Dissolution
tester and
HPLC
5 Sugar coating
5.1 Sealing (Water proofing)
5.1.1 seal and dry the core and cheak its free from any moisture then seal coat to protect the
core from absorbing any moisture.
5.1.2 apply scound coat after first dry to ensure that the core is effectively sealed
5.1.3 Sealants that are commonly used include: shellac, zinc oxide, cellulose acetate
phthalate, polyvinylacetate phthalate, hyroxylpropylcellulose, hyroxypropylmethylcellulose

5.2 Subcoating
5.2.1 coat the tablet by gum solution or syrap
5.2.2 dry the tablet.
5.2.3 rpeate the procedure until the desired tablet shape is achieved.
Subcoating usually involves alternating gum solution with dusting powder (talc or calcium
carbonate) until the desired shape and consistency is achieved
5.2.4 add the colour during the process.

Prepared By mohammad Checked by Tareq Approved By Raya

Date 22/4/2019 Date 22/4/2019 Date 22/4/2019
 Company Name
Raya pharmaceuticals Co. Ltd MF# MF-004

Manufacturing\ processing Rev # 1

instructions and records for Implementation
Title 22/4/2019
CATAFLAM® tablet /effective Date
(50mg /900mg) Page # 8 of 8

Product Name: Cataflam® (diclofenac potassium immediate-release tablets))

Department Solid production Product Code NDC0078
Dosage Form/ Tablet/ 50mg Shelf Life 36 months
strength 3 years
Batch Size 500,000 Weight 900mg

5.2.5 remove the water after every syrup application.

5.3 Grossing (Smoothing)
5.3.1 fill out and smooth irregular features or areas of the tablet
5.3.2 smooth the tablet by polishing After each filling step and refinish the tablet so that a
smooth and finished look is achieved
5.3.3 if found number of irregularities in the tablet use a grossing syrup which contains
suspended solid particles which can better fill the voids in the tablet than a sugar solution.
apply of approximately 60-70% of sugar solids is generally enough to smooth the tablet. The
solution usually contains a mixture of starch, pigments, acacia, gelatine, and opacifier if
needed.
5.3.4 if need appereance of homogenous coating layer add colour during the grossing stage
5.4 Colouring
5.4.1 add multiple sugar solution to ensure that the predetermined colour is achieved.
5.4.2 use the unsoluble pigments for tablet and dispers and suspende in propylene glycol,
glycerin and sucrose (water and sugar).
5.5 Polishing and/or printing
5.5.1 use wax such as carnuba wax, candelila wax, beeswax and hard paraffin to polish the
tablets inside a polishing pan to carried out to impart a shiny distinctive appearance to the
tablet.
5.5.2 print the marking or branda on the surface of tablet using edible ink
5.6 Take sample for QC and test it. Then transfer the tablet for filling area by sutible container

Preserve in tight, light-resistant containers, and store at controlled room

temperature. Do not store above 30°C (86°F). Dispense in tight container (USP).

Prepared By mohammad Checked by Tareq Approved By Raya

Date 22/4/2019 Date 22/4/2019 Date 22/4/2019