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No MASTER FORMULA Page X of Y

Laboratory of Pharmaceutical Prepared

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Technology by

Effective Faculty of Pharmacy Universitas Gadjah Approved

Date Mada by

Production of Paracetamol Syrup

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

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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
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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 )

…
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Composition

Component Function Unit (mg per tablet)

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 Pharmaceutical

equivalence
reuqirements :

Route of administration Pharmaceutical

equivalence
reuqirements :

Dosage Strength Pharmaceutical

equivalence
reuqirements :

Pharmacokinetics

Stability

Drug product quality Identification : Pharmaceutical

attributes Assay : equivalence reuqirements
Conten uniforimity :

Container Closure
System/packaging
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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,
weight, etc)

Identification

Assay

Content Uniformity

Degradation Product

Microbial limits

3. Component of Drug Product

(Batch for xxx)

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

4. Description of drug product component

Name of Ingredient :
Synonym :
Compound structure :
Function in pharmaceutical :
dosage form
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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 :
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 :
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Laboratory of Pharmaceutical Prepared

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Date Mada by

Solubility :
Heat stability :
pH :
Moisture content :
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)
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Critical Quality
Manufacturing Critical Process
Equipment Attributes of
Process Steps Parameter
Product
Mixing Erweka Cubical Mixing speed Content uniformity
Mixer
…
…

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
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10. Data Analysis

(Analyze data obtained)

11. Conclusion
(Give conclusion based on results)
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Laboratory of Pharmaceutical Prepared

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Date Mada by

12. Reference