KOLEJ PROFESIONAL MARA BANDAR MELAKA

COURSE CODE
HLC 2563

COURSE NAME
HALAL PHARMACEUTICALS AND COSMETICS

GROUP
ASSIGNMENT CASE STUDY

NAME & ID 1. ENGKU YAZID ZIDANE BIN ENGKU ASRULSANI (BMH20-07-013)

NUMBER OF 2. HUZAIFI BIN MANSOR (BMH20-07-015)
GROUP
3. MUHAMMAD WAFIY BIN AWALUDIN (BMH20-07-014)
4. MOHAMAD FIRDAUS BIN MOHAMAD HALIMI (BMH20-07-016)

LECTURE`S NAME
NUR EZZATUL NATASSHA BINTI RUSLI

DATE SUBMISSION
4 FEBRUARY 2022 (WEEK 11)

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TABLE OF CONTENT

NO. Content Page

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INTRODUCTION

Halal products are quickly becoming known around the world as a new standard for
safety and quality assurance. Halal items are no longer limited to food, but instead include a
variety of products, including pharmaceuticals. Halal pharmaceuticals are those that include
permitted ingredients and are manufactured in accordance with Islamic guidelines:

a. do not contain any parts or products of animals that are non-halal or any parts or
products of animals which are not slaughtered according to Shariah law; b) do
not
b. contain najs
c. safe for consumption, non-poisonous, nonintoxicating or non-hazardous to health
according to prescribed dosage,
d. not prepared, processed, or manufactured using equipment contaminated with
najs
e. do not contain any human parts or its derivatives that are not permitted by
Shariah law and
f. during its preparation, processing, handling, packaging, storage and distribution,
the halal pharmaceutical products are physically separated from any other
pharmaceutical products that do not meet the requirements stated in items a), b),
c), d) or e) or any other items that have been decreed as non-halal and najs by
Shariah law.

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BACKGROUND OF THE PRODUCT

Cephalexin comes as a capsule, tablet, and suspension (liquid) to take by mouth. It is usually
taken with or without food every 6 or 12 hours for 7 to 14 days, depending on the condition
being treated. Take cephalexin at around the same times every day. Follow the directions on
your prescription label carefully, and ask your doctor or pharmacist to explain any part you do
not understand. Take cephalexin exactly as directed. Do not take more or less of it or take it
more often than prescribed by your doctor.Shake the liquid well before each use to mix the
medication evenly.

You should begin to feel better during the first few days of treatment with cephalexin. If
your symptoms do not improve or get worse, call your doctor.Continue to take cephalexin until
you finish the prescription even if you feel better. If you stop taking cephalexin too soon or skip
doses, your infection may not be completely treated and the bacteria may become resistant to
antibiotics.

Uses of the product

Cephalexin is used to treat certain infections caused by bacteria such as pneumonia and other
respiratory tract infections; and infections of the bone, skin, ears, genital, and urinary tract.
Cephalexin is in a class of medications called cephalosporin antibiotics. It works by killing
bacteria.

Antibiotics such as cephalexin will not work for colds, flu, or other viral infections. Using
antibiotics when they are not needed increases your risk of getting an infection later that resists
antibiotic treatment.

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IDENTIFICATION OF CRITICAL INGREDIENTS

1. Lactose anhydrous

Animal Product

Milk

Any Processing?

Yes No

Critical Material
Non critical material

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2. Magnesium Stearate

Animal Product

Primary Process:
Meat & by Products (Fat,
Bone, Skin, & others)

Are meat and by products

from halal animals?

Yes
No

Further processing?
Haram

No
Yes

Critical Material
Critical Material

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3. FD&C Blue No.1

Other Material

Synthetic

Non organic Organic

Does it contain any

Critical Material
additives?

Yes No

Critical Material Non-Critical Material

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4. Gelatin

Animal Product

Primary process:
Meat & by Products
(Fat, Bone, Skin &
Others)

Are meat and by

products from halal
animals?

No Yes

Haram
Further processing?

Yes No

Critical Material Critical Material

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ASSESSMENT OF THE INGREDIENTS

Anhydrous lactose

1) Sources Bovine milk

2) Justification based on standard and - NE

fatwa

- Are the chemicals used in the manufacture

3) Halal issues of anhydrous lactose obtained from halal
sources?

- If halal animal milk is used as a source of

anhydrous lactose, the animal must be
slaughtered in accordance with Shariah
requirements.

- Is the Anhydrous lactose processing area

free of non -Halal substances.

Magnesium Stearate

- Animal fats, lard or fatty acids from pig’s

1) Sources stomach
- Vegetable (palm oil, coconut, soybean,
sunflower, cotton seed oil)
- Muzakarah Jawatankuasa Majlis Fatwa
2) Justification based on standard and fatwa Kebangsaan stated that medicines with
prohibited sources are only allowed if there
are no medicines from other halal sources,
and used in emergencies.

- Holders of certificates of registration of

medicines must label and declare on the
label if there is an animal source-based
substance such as magnesium stearate on
the pharmaceutical product. If fail to do so,
MOH reserves the right to cancel/suspend
the registration of the drug.
- The sources of magnesium stearate largely
3) Halal issues come from animals such as porcine and
Vegetable.

- Sources from pigs or cows slaughtered not in

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 accordance with sharia.

- If Magnesium Stearate is utilized as a filler in

the production of capsules and tablets, the
manufacturing process must adhere to halal
guidelines.

Gelatin

- Pig skin
1) Sources - Bones and skins of ‘bovine’ animals such as
cows, goats and buffaloes.

- Muzakarah The National Fatwa Council

2) Justification based on standard and fatwa Committee decided that the use of gelatin in
medicine at present is required due to
emergency. If there is a halal substance that
can prevent the drug from being damaged
quickly, then the use of gelatin in the drug is
no longer required.
- If the animal used as a source of gelatin, the
3) Halal issues animal should be properly slaughtered
according to syariah requirement.

- If the manufacture wants to use Gelatin in

pharmaceutical product, they must know its
overall hygiene status

- The sources of gelatin largely come from

animal such as porcine, bovine and poultry.

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CONCLUSION

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REFERENCE

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