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 2 CGMP
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 SCORE
NAME
YEAR 3rd year DATE 08/28/21
LEVEL

LEARNING ACTIVITY for UNIT No. 2

I. Compare and contrast pharmaceutical manufacturing and extemporaneous compounding. Give

examples of each

Pharmaceutical manufacturingis the process used to formulate and create commercially-available drugs.
Comprises physical processes such as blending, compression, filtration, heating, encapsulation, shearing,
tableting, granulation, coating, and drying. While Extemporaneous compounding is the preparation of a
therapeutic product for an individual patient in response to an identified need. It is a practical way to
have medicines supplied when there is no other option. Is the process a compounding pharmacy uses to
create custom medications from base ingredients for patient rather than simply counting out pills or
providing the patient with a pre-mixed formula.

Pharmaceutical manufacturing example are those commercially-available drugs example nitroglycerin,

Zofran and Fentanyl.
Extemporaneous compounding example
o Topical creams, ointments, lotions, gels, e.g. steroids, hormones, coal tar, cholestyramine
o Oral liquids (solutions, suspensions, emulsions, mixtures, elixirs), tinctures, e.g. omeprazole
suspension
o Capsules, tablets, powders, e.g. boric acid capsules Suppositories, pessaries, e.g. paracetamol,
clotrimazole

II. Site 5 examples of product recall in the market

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DATE BRAND NAMES PRODUCT RECALL REASON COMPANY NAME

DESCRIPTION DESCRIPTION

03/25/2021 Zydus Acyclovir Sodium Due to Zydus

Pharmaceuticals Injection, 50 Crystalization Pharmaceuticals
mg/mL, 10 mL and Inc.
20 mL vials
08/26/2020 Zanilast+ Hand sanitizer Product contains Nanomateriales,
1-propanol. SA de CV
02/08/2018 X-Gen Ibuprofen Lysine Some of the vials Exela Pharma
Injection, 20 mg/2 have been found Sciences, LLC
mL to contain
particulate matter
07/14/2021 Neutrogena, Sunscreen Testing identified Johnson &
Aveeno low levels of Johnson
benzene
07/19/2021 CHANTIX Smoking cessation N-Nitroso Pfizer
treatment Varenicline
content above ADI
level

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City of San Jose del Monte, Bulacan, Philippines

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