Kasus-Film Coated Tablets

Technical Data Package
Jokja 5 mg film coated tablets
Author(s): ACPS
Document number (version): TDP.JOK.tab5.001 (1.0)
Page 1 of 25

Introduction 4
Administrative data
3
3.1
3.2
3.3
3.4
Description of the drug substance 5

Instructions for handling of the drug substance
Release process of the drug substance 6
Retain samples of the drug substance
6
ACPS item number of the drug substance
6
Specifications and test instructions for inactive ingredients 7
5
5.1
5.2
Specifications and test instructions for packaging materials

Manufacturers of the primary packaging materials
9
Manufacturers of the secondary packaging materials 9
6
6.1
6.2
6.3
Manufacturing formula10
Powder blend 1 11
Pre-compression blend / core tablets 11
Coating phase 11
7
7.1
7.2
7.3
7.3.1
7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
Manufacturing process 12
General remarks 12
Flow diagram 13
Description of the process 14
Phase 1: Weighing of the constituents 14
Phase 2: Preparation of powder blend 1 and the pre-compression blend 15
Phase 3: Compression of the tablet blend 17
Phase 4. Film coating 18
Phase 5: Bulk packaging of the tablets 19
Phase 5: Bulk packaging of the tablets (continued)
20
Phase 6: Quarantine 20
Tablet core punch specifications21
9
9.1
9.2
9.3
Description of the in-process controls

Pre-compression blend 22
Jokja 5 mg tablets (cores) 23
Jokja 5 mg film-coated tablets 24
10
Release
11
Document history 25
4
6
22
25
Page 2 of 25

List of References
1.
2.
3.
4.
5.
6.
7.
8.
Safety Data Sheet Error: Reference source not found (SDS.NL01.16649)

Incoming Active Substance Specification Error: Reference source not found (IASS.JOK.003
and IASS.WO.JOK.002)
Master Product Formula Jokja 5 mg film coated tablets (MPF.JOK.tab5.001.97)
Primary Packaging Material Specification LDPE bags for bulk packaging
(PPMS.WO.Bag.001)
Secondary Packaging Material Specification HDPE 20 liter Round nestable container CuTec
4420 or HDPE containers Volume Range from 3.6L to 68 (SPMS.WO.13981) or
SPMS.WO.con.002
Secondary Packaging Material Specification Desiccant bags Desi Pak 1/6 to 4 Units
SPMS.WO.Des.001
Incoming Finished Product Specifications Jokja 5 mg tablets (IFPS.NUS.JOK.tab5.001)
Standard Operating Procedure Batch Numbering (SOP.NL01.013)
Page 3 of 25

1
Introduction
Jokja 5 mg film coated tablets (JOK 5 mg) are produced by ACPS, on a batch size of 1 million
pieces intended for the EU market. The production process can be divided into 3 stages, i.e. dry
mixing, compression and coating.
This Technical Data Package (TDP) includes the necessary technical information for the
manufacturer ACPSgenoparm (ACPS), to adequately manufacture JOK 5 mg.
Based on this TDP, the Master Batch Manufacturing Record (MBMR) for manufacturing of JOK 5
mg will be prepared by Error: Reference source not found. The MBMR will be approved by Error:
Reference source not found and ACPS.
The following items will be described:
Quality Control of the incoming materials (drug substance, inactive ingredients and packaging
materials).
The manufacturing process, including specifications and description of the in-process controls
that have to be carried out.
Release procedure for the finished product.
Finished bulk product handling (packaging and labeling).
Administrative data
EU - CTD holder:
Company:
Address:
Country:
ACPS BV
Indonesia
Supplier of Error: Reference source not found drug substance:

Company:
Faculty of Farmacy Univesity Gadjah Mada
Address:
Country:
Indonesia
Page 4 of 25

Drug product manufacturer, in-process control, excipient, primary and secondary packaging
material release site:
Company:
ACPS,
Country:
Indonesia
Drug product release testing sites:

Company:
ACPS,
Country:
Indonesia
Drug product release testing and release site:

Company:
ACPS
Address:
Country:
Indonesia
3
Description of the drug substance
Physical Form: Jokja is a white or slightly yellowish powder.

Structural Formula:
Molecular Formula:
Molecular Weight:
Active Substance Abbreviation: JOK
Instructions for handling of the drug substance

The safety handling instructions and storage conditions for the Drug Substance (DS) are described
in the Safety Data Sheet for Jokja (SDS, see reference 1).
Release process of the drug substance
The quality specifications of the DS are the responsibility of ACPS. Error: Reference source not
found will test the DS. The Qualified Person (QP) of ACPS will issue a Certificate of Analysis
(CoA) and release the DS. Each batch of Error: Reference source not found should be accompanied
by a CoA.
Error: Reference source not found performs an appearance and identification test (IR) on each
container of the DS. The Assay, water content (KF) and OVIresults are to be used for correction of
the weighing of Jokja in each batch. These results will be taken over from the ACPS CoA. Error:
Reference source not found will issue their CoA.
Page 5 of 25

The specifications and routine tests for the DS are described in the Incoming Active Substance
Specification of Error: Reference source not found (IASS, see reference 2).
Retain samples of the drug substance
The contract manufacturer does not have to keep any retaining samples of the Jokja drug substance
for ACPS. This will be done by ACPS
ACPS item number of the drug substance
ACPS item number Jokja: 107158
4
Specifications and test instructions for inactive ingredients
Error: Reference source not found purchases and is responsible for the quality of the inactive
ingredients. Until the manufacturer of an excipient is qualified and approved, the complete Ph. Eur.
testing has to be performed by Error: Reference source not found. CoAs from the approved
manufacturer and Error: Reference source not found are required. These documents are required to
prove that the ingredients comply with the specifications that are presented in the text below.
Excipients with an equivalent quality from different manufacturers may be used after official
approval by ACPS.
All inactive ingredients in the formulation of JOK 5 mg comply with Ph. Eur. monographs.
The following inactive ingredients have to be used in the manufacturing of JOK 5 mg:
Excipient
Lactose monohyACPSte
Calcium hydrogen phosphate dihydrate 1
Maize starch
Carmellose sodium
Magnesium stearate 2
Titanium dioxide
Iron oxide yellow
HPMC
Ethanol 3
1
Supplier
e.g. Meggle
e.g. Budenheim
e.g. Sabamhle
e.g. FMC
e.g. Greven
e.g. Graen
e.g.Rockwood
e.g. Kronos
e.g. BFB
Quality
Ph. Eur
Ph. Eur
Ph. Eur
Ph. Eur
Ph. Eur
Ph. Eur
Ph. Eur
Ph. Eur
Ph. Eur
Calcium hydrogen phosphate dihydrate is used to compensate the mass change of the tablet
due to the DS correction for assay (by HPLC, dry basis), OVI and water content.
After calculation of the correction factor F, an amount of:
[Batch size (tablets) x 5 mg x [F-1]]
is deducted from the amount of Calcium hydrogen phosphate dihydrate.
Page 6 of 25

2
From vegetable origin
Removed during the film coating process
Page 7 of 25

Specifications and test instructions for packaging materials
Error: Reference source not found purchases and is responsible for the quality of the packaging
material. Error: Reference source not found routinely examines all packaging materials. CoAs and /
or Certificates of Conformances (CoCs) from the manufacturer and Error: Reference source not
found for all packaging materials should be available. These documents are required to prove that
the packaging materials comply with the specifications that are presented in the text below.
Packaging materials with an equivalent quality from different manufacturers may be used after
approval by ACPS.
All packaging materials for bulk JOK 5 mg are listed below with the exception of rattails (or
ribbons, or pull-tight seals):
Primary Packaging Materials
a)
LDPE bags for bulk packaging

Characteristics: thickness 100 m
Construction:
For detailed information, see reference 4.
Secondary Packaging Materials

a)
HDPE 20 liter Round nestable container CuTec 4420 or HDPE containers Volume Range
from 3.6L to 68
Characteristics: Dedicated, ACPS specific colored lid
Construction:
b)
Desiccant bags Desi Pak 1/6 to 4 Units

Characteristics: 2 drying units
Construction:
Page 8 of 25

Manufacturers of the primary packaging materials
LDPE bags for bulk packaging
Company:
Address:
Country:
or
Company:
Address:
Country:
RHEIN-PLAST GmbH
Gewerbegebiet Ungstein, 67098 Bad Drkheim
Germany
General de Manipulados Plsticos S.A.
C/ Solsons no. 58-60, 08211 Castellar de Valles,
Barcelona
Spain
Manufacturers of the secondary packaging materials

HDPE 20 liter Round nestable container CuTec 4420 or HDPE containers Volume Range from
3.6L to 68
Company:
Address:
Country:
CurTec Nederland B.V.

Spoorlaan Noord 92, Postbus 25, 5120 AA Rijen
The Netherlands
Desiccant bags Desi Pak 1/6 to 4 Units

Company:
Address:
Country:
Sudchemie
Different per region, see reference 6
Different per region, see reference 6
Page 9 of 25

6
Manufacturing formula
The composition is described in the Master Product Formula of Jokja 5 mg film-coated tablets,
MPF.JOK.tab5.001.97. Below the manufacturing formula of a production batch of Jokja 5 mg filmcoated tablets is described.
Ingredients
Jokja 1
Calcium hydrogen phosphate dihydrate 2
Maize starch
Carmellose sodium
Magnesium stearate
Titanium dioxide 3
Iron oxide yellow
HPMC 3
Ethanol 3, 4
Total
1
Per 5 mg tablet
5 mg
30.8 mg
60.0 mg
60.0 mg
5.00 mg
1.70 mg
2.00 mg
0.02 mg
6.00 mg
69.10 mg
170.52 mg
1,000,000 tablets
5 kg
30.80 kg
60.00 kg
60.00 kg
5.00 kg
1.70 kg
2.00 kg
0.02 kg
6.00 kg
69.10 kg
170.520 kg
Prior to manufacturing a correction factor is calculated. The correction factor compensates for assay by HPLC (dry
basis), OVI and water content (KF). The assay, OVI and water (KF) are presented on the Certificate of Analysis from
ACPS BV that should accompany each batch of Jokja.
100 100
F=
(100 - OVI (%) - H2O (%)) assay (%)
When the assay of Jokja drug substance (HPLC, dry basis) is >100%, then 100.0 % has to be used in the equation.
Calcium hydrogen phosphate dihydrate is used to compensate for the mass change of the tablet. The compensation
mass is defined as:
C = Batch size 5 [F - 1] (mg)
A coating suspension containing 10 m/m % of solids will be prepared
Removed during the coating process
Page 10 of 25

Powder blend 1
Ingredients
Jokja
Calcium hydrogen phosphate dihydrate
Maize starch
Carmellose sodium
Total
Per 5 mg
tablet
5.0 mg
30.8 mg
60.0 mg
60.0 mg
5.00 mg
160.80 mg
1,000,000
tablets
5.0 kg
30.8 kg
60.0 kg
60.0 kg
5.00 kg
160.80 kg
Pre-compression blend / core tablets

Ingredients
Powder blend 1 (see 6.1)
Magnesium stearate
Total
Per 5 mg
tablet
160.80 mg
1.70 mg
162.50 mg
1,000,000
tablets
160.80 kg
1.70 kg
162.50 kg
Per 5 mg
Tablet
162.50 mg
2.00 mg
6.00 mg
0.02 mg
69.10 mg
170.52 mg
1,000,000
tablets
162.50 kg
2.00 kg
6.00 kg
0.02 kg
69.10 kg
170.52 kg
Coating phase
Ingredients
Cores (see 6.2)
Titanium dioxide 1
HPMC 1
Iron oxide yellow
Ethanol 1, 2
Total
1
A coating suspension containing 10 m/m % of solids will be prepared
Removed during the coating process
Page 11 of 25

7
Manufacturing process
General remarks
Before manufacturing the batches, the MBMR has to be prepared by Error: Reference source not
found, based on this TDP. After approval by ACPS, it will be used in the manufacturing process of
JOK 5 mg.
The equipment and production rooms are checked for cleanliness and correct product identification
by the operator of the manufacturing process. The operator also checks to ensure that the raw
materials are correctly labeled and released.
Manufacturing is conducted in a relative humidity monitored and temperature controlled
environment utilizing equipment and facilities which are in compliance with current Good
Manufacturing Practice (cGMP).
The pre-compression blend and tablet cores are stored in stainless steel containers or in double
transparent LDPE bags in a HDPE container with a desiccant bag between both transparent bags.
All materials are stored at room temperature according to Error: Reference source not found
standard procedure(s). Unless otherwise stated all operations are carried out at controlled room
temperature.
In-process controls, equipment and operating procedures are specified in the MBMR. Operating
parameters, in-process and reconciliation data have to be recorded in the BMR.
Deviations from the MBMR and TDP will have to be justified by a written deviation report. ACPS
must be informed immediately if deviations in the manufacturing process occur.
Page 12 of 25

Flow diagram
Phase 1
Weighing of the constituents
Phase 2
Preparation of powder blend 1 and pre-compression
blend
Phase 3
Compression of the tablets
Phase 4
Film coating of the tablets
Phase 5
Bulk packaging
Phase 6
Quarantine
Phase 7
Release
Page 13 of 25

Description of the process

Phase 1: Weighing of the constituents
Equipment & Materials:
Balance
Sieve 1.25 mm
Operations:
1. Weigh the Jokja, Lactose
monohyACPSte,
Calcium
hydrogen
phosphate
dihydrate, Maize starch,
Carmelose
sodium
and
Magnesium stearate (separate
weighed for each powder
blend, see 6.1, and 6.2 in
separate drums and sieve
each individual material
through a 1.25 mm sieve.
(quantities corresponding to
the prescribed number of
tablets)
Controls:
check balances ?
equipment clean ?
Check batch numbers and release
of the raw materials.
Adjust the Jokja and Calcium
hydrogen phosphate dihydrate
weigh-in with the correction
factor.
Check whether balance read outs
are double checked and stated in
the BMR (double signed).
(check quantity of drums)
Page 14 of 25

Phase 2: Preparation of powder blend 1 and the pre-compression blend

Equipment & Materials:
Stainless steel mixing bin
Free-fall mixer
HDPE containers
Desiccant bags
LDPE bags (transparent)
Operations:
2. Add the Jokja, Lactose
monohydrate,
Calcium
hydrogen
phosphate
dihydrate, Maize starch and
Carmelose sodium into a
mixing bin and mix for 20
minutes at 6 rpm (powder
blend 1).
3.
Screen the Magnesium

stearate through a (1.25 mm)
sieve. Add powder blend 1
and magnesium stearate into
a mixing bin and mix for 5
minutes at 6 rpm. (precompression blend).
4. Check the appearance of the

blend.
Controls:
Check balances ?
Equipment clean ?
Note the time and rotation speed

of the mixer.
Record yield
Note the time and rotation speed

of the mixer.
Record yield
White, homogeneous blend [note
any anomalous results in the
BMR]
Page 15 of 25

Phase 2: Preparation of the pre-compression blend (continued)

Operations:
5. Take a sample of the precompression blend for inprocess controls.
6. Transfer the pre-compression
mixture into stainless steel
containers or in a transparent
Stamylan inner bag together
with a transparant Stamylan
outer bag in a HDPE
container with a desiccant
bag between both transparent
bags.
7. Weigh the pre-compression
blend.
Controls:
Check the sample for the tests as
described in paragraph [note all
results in the BMR].
Note the amount and type of

containers.
Record yield (98-101%). Values
outside these specifications need
proper justification in the BMR.
Page 16 of 25

Phase 3: Compression of the tablet blend

Equipment:
Rotary tablet press
Described punches
Operations:
8. Equip the tablet press with for
Jokja 3.75 mg film-coated
tablets specific punches. The
punches are round (7 mm).
The lower punch is debossed
with "JOK 5".
Controls:
Equipment clean ?
Correct punches ?
9. Transfer the homogeneous

pre-compression blend into
the flowbin to the filling
chamber of the tablet press.
10. Adjust the machine settings in
such a way that tablets are
produced
having
the
following characteristics:
Mass:
162.5 mg
4%
Friability:
0.5 %
Disintegration: 15 min.
Target Hardness: 60 - 70 N
Alarm Hardness: 55 - 75 N
Thickness: 3.5 4.0 mm
Diameter: 7.0 0.2 mm
Record machine speed.

Record compression force.
Check the samples for the tests as
described in paragraph [note all
results in the BMR].
Adjust the machine settings if this
is indicated by IPC results.
11. Take samples for IPC during

the compression process.
12. The tablets are transferred
from the tabletting machine to
the deduster. Store the tablets
in properly labelled containers
with desiccant bag until the
film coating process.
13. Weigh the total amount of
tablets.
Record yield (96-100 %, on

theoretical basis). Values outside
these specifications need proper
justification in the BMR.
Page 17 of 25

Phase 4. Film coating
Equipment:
Balance(s)
Stainless steel mixer (high speed)
Film coater
Operations:
14. Weigh the Titanium dioxide,
HPMC and the iron oixide
yellow and sufficient Ethanol
to
prepare
a
coating
suspension with 10 % m/m%
solids. (Including a 10 m/m %
coating excess).
Controls:
Equipment clean ?
Check balances
Check whether balance read outs

are double checked and stated in
the BMR (double signed).
15. Transfer the Titanium dioxide,

HPMC, iron oxide and
sufficient Ethanol into the
high speed mixer and stir for
at least 45 minutes (stirred
gently
to
avoid
air
entrapment)
Record machine speed.

Record stirring time.
16. Sieve the suspension trough a

0.1 mm sieve
Record
temperature
inlet,
temperature outlet, rotation speed,
air flow, nozzle distance, nozzle
shape and number of spray guns.
17. Transfer the tablets into the

coating machine and warm the
tablets. Weigh 50 tablets after
the outlet temperature has
reached 40 C; average tablet
weight = M0.
Start coating and regularly
check the mass increase. Stop
coating when the average final
tablet weight (n=10) of (M0 *
1.050) is reached.
18. Weigh the total amount of
tablets.
Average tablet weight before

coating.
Coating mass increase range:
minimal (M0* 1.040) mg and
maximal (M0*1.060) mg
Record yield (96-100 %, on
theoretical basis). Values outside
these specifications need proper
justification in the BMR.
Page 18 of 25

Phase 5: Bulk packaging of the tablets

Materials:
LDPE bags transparent
CurTec containers (HDPE)
Desiccant bags
Rat-tail ribbons
Security liner
Operations:
19. Check for release of all
secondary
and
primary
packaging materials.
20. Transfer the tablets into a
double LDPE bag (inner bag
is transparent) into the
CurTec container. The outer
bag contains an identification
label.
Controls:
Balance(s) calibrated?
Equipment released for use?
Correct packaging materials and

released for use?
Correct batch number and
amount of tablets on the
container label.
21. Transfer
the
described
number
of
tablets,
corresponding to 14,705 g,
into the double LDPE bags
(approx. 85,000 tablets per
bulk container).
Check if the bags contain the

correct amount of tablets.
Correct mass in each container?
22. Secure the inner bag with a

rat-tail ribbon. Put on top of
the bag a desiccant bag.
Is the inner bag secured?

Is the desiccant bag present?
23. Close the outer (black) bag

with a rat-tail ribbon.
Is the outer bag secured?
Page 19 of 25

Phase 5: Bulk packaging of the tablets (continued)

Operations:
Controls:
24. Close the CurTec container
which is filled with the
correct amount of tablets.
Label the (black) outer bag
and the outside of the
container. The label should
state the name of the product,
batch
number
(ACPS
Outer bag labelled
SOP.013), mass, number of
Container labelled
tablets and the production
Correct label?
date.
Clearly identify the rest
container (additional label
with "rest") clearly state
the rest amount.
25. Secure the container-closure
system with a security liner.
Are all CurTec containers

secured with a security liner?
Phase 6: Quarantine
Operations:
26. Before packaging the bulk
tablets will be stored under
Quarantine until the tablets
are finally packaged.
Page 20 of 25

8
Tablet core punch specifications
Below, a ACPSwing of the tablets are given.
Figure 1: Top view tablet (not scaled)
Figure 2: Side view tablet (not scaled)
Page 21 of 25

9
Description of the in-process controls
Samples for in-process controls from the "pre-compression blend", cores and of Jokja 5 mg filmcoated tablets are taken for analysis during the manufacturing process. The results of these inprocess controls are written down in the BMR, which have to be signed by the operator for
approval.
Pre-compression blend
- Appearance
The appearance of the pre-compression blend should comply with the specification i.e. white to offwhite free flowing powder.
- Loss on drying
The loss on drying is determined using an in-house method. The pre-compression blend is dried at
100 C and examined by IR. The loss on drying is not more than 6.0 %. The result has to be
incorporated in the BMR.
- Bulk density
The bulk density of the pre-compression blend is determined by an in-house procedure. The result
has to be incorporated in the BMR for information only.
- Tapped density
The tapped density of the pre-compression blend is determined by an in-house procedure. The result
- Particle size distribution
The particle size distribution of the pre-compression blend is determined by sieve analysis. The
result has to be incorporated in the BMR for information only.
- Relative humidity
The relative humidity of the pre-compression blend is determined by an in-house procedure. The
result has to be incorporated in the BMR for information only.
- Flowability
The flowability of the pre-compression blend is determined by an in-house procedure. The result
Page 22 of 25

Jokja 5 mg tablets (cores)

- Appearance
The tablets should comply with the specifications, i.e. white, round, tablet, (7 mm). The lower
punch is debossed with JOK 5. The tablet diameter should be 6.8 - 7.2 mm. The thickness should
be 3.5 - 4.0 mm. The inscriptions should be clearly readable.
- Uniformity of mass/average mass
The test for uniformity of mass is performed several times, as described in the table below, during
the compression of the tablets. The tablets should have an average mass of 162.5 mg 4.0 %.
- Hardness
The hardness of the tablets is determined as described in the table below. The target hardness is 60 70 N and the alarm limit is 55 - 75 N.
- Friability
The friability of the tablets is determined only at set up of the machine settings. The friability
should be not more than 0.5 %.
- Disintegration time in HCl
The disintegration time of the tablets in 0.1 M HCl should be not more than 5 minutes.
- Water content
The water content of the tablets is determined by KF and should be not more than 6.5 %.
- Loss on drying
The loss on drying of the tablets should be not more than 6.5 %
- Capping
The test for capping is performed according to an internal procedure.
-
Identification and Assay of Jokja in uncoated Jokja 5 mg
tbletsby UV-spectrophotometry.
The identification and assay of Jokja in uncoated tablets by UV-spectrophotometry is determined

using QC.JOK.010.C. The assay should be 97 105 %.
Page 23 of 25

Sampling plan in process Jokja 5 mg tablets (cores)

Controls
Appearance
Uniformity/average mass
Hardness (average)
Friability
Capping
Disintegration time
Height
Water content
Loss on drying
Identification and Assay
Quantity
(tablets)
10
20
10
20
20
6
10
20
20
14
Frequency
Requirement
continuous
each 30 min.
each 30 min
at set up
continuous
at set up
each 30 min.
at set up and finish
complies
162.5 4 %
60 - 70 N
0.5 %
none
5 min.
3.5 - 4.0 mm
6.5 %
6.5 %
97 - 105 %
Jokja 5 mg film-coated tablets

Controls
Appearance
Average mass increase coated

tablet
Quantity
(tablets)
10
50
10
Frequency
Requirement
continuous
Coating increase throughout

coating.
Smooth coated, yellow
tablets.
Start:M0
End:
M0 * 1.050 (range 0.010)
start-up = M0
Throughout and at
the end of coating.
Jokja 5 mg film-coated tablets are tested and released according to the Incoming Finished Product
Specification (IFPS.NUS.JOK.tab5.001).
Page 24 of 25

10
Release
Release testing will be performed on the JOK 5 mg by ACPS according to the current finished
product specifications.
Error: Reference source not found will only perform the appearance, identification (IR) and water
content (KF) test on the DS, the release testing of the excipients and packaging materials.
ACPS will issue the CoA based on the results obtained from the bulk finished product release
testing. Final release will be performed by the Quality Assurance (QA) of ACPS.
Error: Reference source not found will approve the executed BMRs and release test a representative
sample of the bulk and or finished packed product according to the current finished product
specifications. They will issue the CoA based on the results obtained.
If the tablets do not comply with the approved release specifications, the responsible persons at
Error: Reference source not found and ACPS will discuss this matter thoroughly, evaluating both
the reason for non-compliance and the appropriate steps that are to be taken to resolve the issues.
11
Document history
Page 25 of 25

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Technical Data Package

Jokja 5 mg film coated tablets

Document number (version): TDP.JOK.tab5.001 (1.0)

Technical Data Package

Description of the drug substance 5

Specifications and test instructions for inactive ingredients 7

Specifications and test instructions for packaging materials

Tablet core punch specifications21

Description of the in-process controls

Document number (version): TDP.JOK.tab5.001 (1.0)

Technical Data Package

Safety Data Sheet Error: Reference source not found (SDS.NL01.16649)

Document number (version): TDP.JOK.tab5.001 (1.0)

Technical Data Package

Supplier of Error: Reference source not found drug substance:

Document number (version): TDP.JOK.tab5.001 (1.0)

Technical Data Package

Drug product release testing sites:

Drug product release testing and release site:

Description of the drug substance

Physical Form: Jokja is a white or slightly yellowish powder.

Instructions for handling of the drug substance

Document number (version): TDP.JOK.tab5.001 (1.0)

Technical Data Package

Specifications and test instructions for inactive ingredients

Document number (version): TDP.JOK.tab5.001 (1.0)

Technical Data Package

From vegetable origin

Removed during the film coating process

Document number (version): TDP.JOK.tab5.001 (1.0)

Technical Data Package

Specifications and test instructions for packaging materials

LDPE bags for bulk packaging

Secondary Packaging Materials

Desiccant bags Desi Pak 1/6 to 4 Units

Document number (version): TDP.JOK.tab5.001 (1.0)

Technical Data Package

Manufacturers of the secondary packaging materials

CurTec Nederland B.V.

Desiccant bags Desi Pak 1/6 to 4 Units

Document number (version): TDP.JOK.tab5.001 (1.0)

Technical Data Package

A coating suspension containing 10 m/m % of solids will be prepared

Removed during the coating process

Document number (version): TDP.JOK.tab5.001 (1.0)

Technical Data Package

Pre-compression blend / core tablets

A coating suspension containing 10 m/m % of solids will be prepared

Removed during the coating process

Document number (version): TDP.JOK.tab5.001 (1.0)

Technical Data Package

Document number (version): TDP.JOK.tab5.001 (1.0)

Technical Data Package

Document number (version): TDP.JOK.tab5.001 (1.0)

Technical Data Package

Description of the process

Document number (version): TDP.JOK.tab5.001 (1.0)

Technical Data Package

Phase 2: Preparation of powder blend 1 and the pre-compression blend

Screen the Magnesium

4. Check the appearance of the

Note the time and rotation speed

Note the time and rotation speed

Document number (version): TDP.JOK.tab5.001 (1.0)