Colegio de San Gabriel Arcangel

City of San Jose del Monte, Bulacan, Philippines

LEARNING ACTIVITY SHEET (LAS)

College College of Medical Allied Courses (CMAC)

Program: BS Pharmacy
Course Title Pharmaceutical Manufacturing & CGMP with Quality Assurance

Course Code IP 7
Unit No. and Title Unit 3 Formulation of Liquids
LAS Code
References The Theory and Practice of Industrial Pharmacy by Leon Lachman, latest
edition
2. PICs, “GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL
PRODUCTS”, PE009-13, 1 January 2017.
3. “Pharmaceutical CGMPs for the 21st Century – A Risk-Based Approach”,
USFDA, August 21, 2002
4. ICH Q8(R2), Guideline on Pharmaceutical Development, November 2007
5. ICH Q9 Quality Risk Management, November 9, 2005.
6. ICH Q10, Pharmaceutical Quality System, June 2008.
7. PICs, “GUIDE TO GOOD DISTRIBUTION PRACTICE FOR MEDICINAL
PRODUCTS’, 1 June 2014
8. ASEAN (ACCSQ) GUIDELINE ON STABILITY STUDY OF DRUG PRODUCT
February 22, 2005, Ver. 6 May 2013
9. ASEAN GUIDELINE ON STABILITY STUDY OF DRUG PRODUCT, Questions
and Answers/Issues VERSION – 1, 01 November 2006
10. ASEAN GUIDELINE ON STABILITY STUDY OF DRUG PRODUCT, Questions
and Answers/Issues VERSION – 2, 24 July 2007
11. ICH Q6A, Specifications: Test Procedures and Acceptance Criteria for New
Drug Substances and New Drug Products: Chemical Substances, 6 October
1999
12. ICH Q1E, Evaluation of Stability Data, 6 February 2003.

13. WHO TRS 953, 2009, Annex 2.

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FULL NAME SCOR

E
YEAR LEVEL DATE

LEARNING ACTIVITY for UNIT No. 3

Give the function of each ingredient

Ingredients Amount Use

drug 10kg drug is any chemical substance
that causes a change in an
organism's physiology or
psychology when consumed.
Sodium benzoate 5kg inhibits the growth of potentially
harmful bacteria, mold, and
other microbes in food,
thus deterring spoilage
menthol 0. 5kg Menthol provides a cooling
sensation when applied to the
skin or other tissues (such as the
tongue, gums, or inside the
cheeks).
alcohol 250L alcohol is mixed with water for
use as a rubbing-alcohol
antiseptic. It is also used in
aftershave lotions, hand lotions,
and other cosmetics.
flavor 25L The primary function of flavors
is to add taste to foods, as they
have no nutritional properties.
FD&C Yellow # 6 0. 5KG FD&C Yellow no. 6 is a synthetic
food colorant (food dye, food
coloring) with a reddish-yellow
hue used to color beverages,
cereals bakery goods,
confections, and ice cream.
glycerin 250L This medication is used as a
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moisturizer to treat or prevent
dry, rough, scaly, itchy skin and
minor skin irritations (e.g., diaper
rash, skin burns from radiation
therapy).
Sorbitol solution 500L Sorbitol is used to relieve
occasional constipation and
irregularity. Sorbitol generally
produces bowel movement in
1/4 to 1 hour when used rectally.
Sorbitol is also used as a
pharmaceutical aide
(sweetener). For other uses of
sorbitol, ask your doctor.
Granulated sugar 2750kg Granulated sugar has had all of
the naturally present molasses
refined out of it. It is the sugar
that is most commonly used in
baking. The fine crystals in
granulated sugar don't cake
together, which makes it perfect
for measuring, sprinkling onto
food and dissolving into drinks
Purified water qs 5000L Purified water is intended for use
in formulation of medicines that
are not intended to be sterile
and apyrogen Purified water is
widely used for oral and topical
products and in granulation
processes for tablets and
capsules

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II

Ingredients Amount Use

drug 382g drug is any chemical substance
that causes a change in an
organism's physiology or
psychology when consumed
Potassium Citrate 10g This medication is used to make
the urine less acidic. This effect
helps the kidneys get rid of uric
acid, thereby helping to prevent
gout and kidney stones
Propylene glycol 20ml it is used to absorb extra water
and maintain moisture in certain
medicines, cosmetics, or food
products. It is a solvent for food
colors and flavors, and in the
paint and plastics industries
alcohol 250L alcohol is mixed with water for
use as a rubbing-alcohol
antiseptic. It is also used in
aftershave lotions, hand lotions,
and other cosmetics.
Benzoic acid 200mg Benzoic acid is most commonly
found in industrial settings to
manufacture a wide variety of
products such as perfumes, dyes,
topical medications and insect
repellents.

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FD&C Yellow # 6 0. 5g FD&C Yellow no. 6 is a synthetic
food colorant (food dye, food
coloring) with a reddish-yellow
hue used to color beverages,
cereals bakery goods,
confections, and ice cream.
Alcohol, 95% 250ml A 70% solution of Ethyl Alcohol
95% kills organisms by
denaturing their proteins and
dissolving their lipids and is
effective against most bacteria,
fungi and many viruses, but is
ineffective against bacterial
spores.
Orange oil 3ml
lift your mood or reduce stress,
treat skin conditions such
as acne, reduce pain
or inflammation relieve stomach
upset

Methyl Paraben 180g Methylparaben is an anti-fungal

agent often used in a variety of
cosmetics and personal-care
products. It is also used as a food
preservative and has the E
number E218
Purified water qs 1000ml Purified water is water that has
been filtered or processed to
remove impurities like chemicals
and other contaminants. It is
usually produced using
groundwater or tap water.
Through purification, many types
of impurities are removed

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