Doc.

No MASTER FORMULA Page X of Y

Laboratory of Pharmaceutical Prepared

Version
Technology by

Effective Faculty of Pharmacy Universitas Gadjah Approved

Date Mada by

P3 [Active Ingredients] Tablet Production using Wet Granulation Method

Created by 1.
2.
3.
4.

Group / Sub-group

Assistant 1.
2.

Lecturer

Date

1. Product Details
(detail information related to product)

Name of product

Composition

Strength

Indication

Manufacturer

Target Countries

Packaging

Batch Size

Product Category Generic/Ethical/OTC

 Doc. No MASTER FORMULA Page X of Y

Laboratory of Pharmaceutical Prepared

Version
Technology by

Effective Faculty of Pharmacy Universitas Gadjah Approved

Date Mada by

Information of Comparator Product

(information related to product reference)
General Information
Name of product

Manufacturer

Dosage Form

Strength

Composition

Container Closure
System/Packaging
Price

Storage Condition

Shelf Life

Clinical Aspect

Parameter Description

Pharmacology Class

Indication

Route of administration

Dosage and direction to use

Contraindication

Precaution
 Doc. No MASTER FORMULA Page X of Y

Laboratory of Pharmaceutical Prepared

Version
Technology by

Effective Faculty of Pharmacy Universitas Gadjah Approved

Date Mada by

Pharmacokinetics Aspects

Parameter Description

Absorption Cmax :
Tmax :

Distribution

Metabolism

Elimination t1/2

Physicochemical Characterisation

Parameter Description

Product description

Identification

Expiry date/Shelf life

Strength /label claim

For Solid Product

(e.g. average weight, coating,
thickness, hardness,
diameter, disintegration
time, assay, etc )

…
 Doc. No MASTER FORMULA Page X of Y

Laboratory of Pharmaceutical Prepared

Version
Technology by

Effective Faculty of Pharmacy Universitas Gadjah Approved

Date Mada by

Composition

Component Function Unit (mg per tablet)

Drug Substance /zat aktif

Excipient

2. Quality Target Product Profile (QTPP) Proposed Product

(Target kualitas/parameter yang ingin dicapai pada produk yang diusulkan, dapat
mengacu pada produk acuan/referensi)

QTPP Element Target Justification

Dosage Form

Route of administration

Dosage Strength

Pharmacokinetics

Stability

Drug product quality

attributes

Container Closure
System/packaging

Drug Product Critical Quality Attributes (CQA) of Drug Product

(Parameter spesifik yang diinginkan pada produk, sesuaikan dengan bentuk sediaan)

Critical Quality Target Justification

Attributes (CQA)

Physical Attributes
(e.g. thickness, diameter,
Doc. No MASTER FORMULA Page X of Y

Laboratory of Pharmaceutical Prepared

Version
Technology by

Effective Faculty of Pharmacy Universitas Gadjah Approved

Date Mada by

weight, etc)

Identification

Assay

Content Uniformity

Degradation Product

Microbial limits

3. Component of Drug Product

Component Function Unit (mg per tablet) Unit (mg per batch)

Drug Substance /zat

aktif

Excipient

4. Description of drug product component

Name of Ingredient :
Synonym :
Compound structure :
Function in pharmaceutical :
dosage form
Physical appearance :
Density :
Melting point :
Solubility :
Doc. No MASTER FORMULA Page X of Y

Laboratory of Pharmaceutical Prepared

Version
Technology by

Effective Faculty of Pharmacy Universitas Gadjah Approved

Date Mada by

Heat stability :
pH :
Moisture content :
Incompatibility :
Therapeutic dose :
Particle Size :
Justification (describe the reason :
for material usage on the
product)

Name of Ingredient :
Synonym :
Compound structure :
Function in pharmaceutical :
dosage form
Physical appearance :
Density :
Melting point :
Solubility :
Heat stability :
pH :
Moisture content :
Incompatibility :
Therapeutic dose :
Particle Size :
Justification (describe the reason :
for material usage on the
product)

Name of Ingredient :
Synonym :
Compound structure :
Function in pharmaceutical :
dosage form
Physical appearance :
Density :
Melting point :
Solubility :
Heat stability :
pH :
Moisture content :
 Doc. No MASTER FORMULA Page X of Y

Laboratory of Pharmaceutical Prepared

Version
Technology by

Effective Faculty of Pharmacy Universitas Gadjah Approved

Date Mada by

Incompatibility :
Therapeutic dose :
Particle Size :
Justification (describe the reason :
for material usage on the
product)

5. Calculation of drug substance and excipient

6. Production workflow
(Draw overall manufacturing process using flowchart)

Manufacturing Equipment Critical Process Critical Quality

Process Steps Parameter Attributes of
 Doc. No MASTER FORMULA Page X of Y

Laboratory of Pharmaceutical Prepared

Version
Technology by

Effective Faculty of Pharmacy Universitas Gadjah Approved

Date Mada by

Product
Mixing
…
…

7. Container Closure System/Packaging

Primary Packaging
Material
Specification
Unit Size
Secondary Packaging
Material
Specification
Unit Size

8. Storage condition

Storage Condition

Justification

9. Testing Results
Tablet size
Tablet diameter Tablet thickness
No Mean SD CV
(mm) (mm)

Tablet hardness test

 Doc. No MASTER FORMULA Page X of Y

Laboratory of Pharmaceutical Prepared

Version
Technology by

Effective Faculty of Pharmacy Universitas Gadjah Approved

Date Mada by

No Tablet hardness (Kg) Mean SD CV

Tablet friability test

Tablet weight (early) :

Tablet weight (final) :

% Friability :

10. Data Analysis

(Analyze data obtained)
 Doc. No MASTER FORMULA Page X of Y

Laboratory of Pharmaceutical Prepared

Version
Technology by

Effective Faculty of Pharmacy Universitas Gadjah Approved

Date Mada by

11. Conclusion
(Give conclusion based on results)
 Doc. No MASTER FORMULA Page X of Y

Laboratory of Pharmaceutical Prepared

Version
Technology by

Effective Faculty of Pharmacy Universitas Gadjah Approved

Date Mada by

12. Reference