1

Subject Code: Ph. MANU

Course Description: Pharmaceutical Manufacturing
Name: __________________________________________________
Year/ Section:__________________________________________
Semester : _____________________________________________
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PHARMACEUTICAL MANUFACTURING AND

CURRENT GOOD MANUFACTURING
PRACTICE WITH QUALITY ASSURANCE

Laboratory Activity

UNIVERSIDAD DE ZAMBOANGA
SCHOOL OF ALLIED MEDICINE
DEPARTMENT OF PHARMACY

APPROVAL
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This is to certify that this Laboratory Workbook has been approved for use, exclusively in the School
of Allied, Department of Pharmacy of Universidad de Zamboanga in the course Pharmaceutical
Manufacturing and Current Good Manufacturing Practices
for the First Semeste,r Academic, Year 2020 -2021.

Copyright:
All rights reserved. No part of this module may be reproduced, stored in a retrieval system or
transmitted in any form or by any means, electronic, mechanical, photocopying, recording or
otherwise, without the prior written consent of the Author/s and
Universidad de Zamboanga.

Dr. Mary Belen T. Mogol

Professor 1

Approved by:

Dr. Bashiruddin A. Ajihil

Vice-President for Academic Affairs

FOREWORD

This workbook contains the essential information to enhance their knowledge

about Pharmaceutical Manufacturing Laboratories. It also includes the activities
that transpire in the laboratories. This manual is conceived mainly for students
who can not access the internet and also those who can online.

This workbook is mainly for Pharmacy students who are about to undergo a
manufacturing internship after passing this course Pharmaceutical
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Manufacturing. This is conceived to serve as guide to help them carry out the
duties and responsibility as a future Pharmacists and member of the health care
teams. Thus after this , training in all areas is further intensified for all pharmacy
interns.

MARY BELEN T. MOGOL, RPh., MSPh. Ph.D

Dean, Pharmacy
School of Allied Medicine
Universidad de Zamboanga
09177042832
Email add: marybelen.mogol@uz.edu.ph

TABLE OF CONTENTS

PAGE

Cover Page …………………………………………………………………………. 1

Title Page ………………………………………………………………………… 2

Approval ………………………………………………………………………. .. 3

Copyright …………………………………………………………………………. 3

Foreword …………………………………………………………………………. 4

Table of Contents ………………………………………………………………….. 5

Activity 1: Management System………………………………………………… 6

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Activity 2: Current Good Manufacturing Practices …………………………. 8

Activity 3: Stickers …………………………………………………………………. 11

Activity 4: Documentation ………………………………………………………. 13

Activity 5: Line Clearance ………………………………………………………. 17

Activity 6: Manufacture of Pharmaceuticals ………………………………… 20

Activity 7: Sampling and Inspection of Defects …………………………….. 22

Activity 8: sampling and Sampling Plan ……………………………………… 26

Activity 9: In-Process Quality Control (IPQC for Solids ……………………. 29

Activity 10: Sampling and Inspection ………………………………………… 31

Activity 11: In-Process Quality Control (IPQC) for Liquids …………………

33

Evaluation of Performance Rubrics ……………………………………….. 36

References ……………………………………………………………………….. 39

ACTIVITY NO. 1

MANAGEMENT SYSTEMS

Name: _______________________________ Date:___________________

OBJECTIVES:

1. To familiarize with the different levels of management, positions and divisions of the
manufacturing company.
2. To discuss the functions of each department and position.

TOPICS FOR DISCUSSION:

The Organizational Set-Up

1. Definition of Terminologies
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 Manufacturing
 Manufacturing Pharmacy
 Organization
 Chart
2. Typical Organizational Chart of a Manufacturing Company
3. Levels of Management
4. Functions/Duties of each Department
5. Roles of the Manufacturing Pharmacist
6. Systems and Procedures

ACTIVITIES:

1. Prepare an organizational chart of the company showing the levels of management and the
different departments.
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2. Describe the main function/s of the management levels and the functions of
each department.

Conclusion: __________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________
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ACTIVITY NO. 2

Name:__________________________Date:_______________

CURRENT GOOD MANUFACTURING PRACTICES

OBJECTIVES:

1. To identify the GMP’s applied in the different areas of the company.

2. To discuss the application of GMP’s in the actual laboratory set-up.

TOPICS FOR DISCUSSION:

Current Good Manufacturing Practices in the following areas:

 Buildings and Premises

 Equipment
 Personnel
 Components
 Master Formula and Batch Production Record
 Production and Control Procedures
 Laboratory Controls
 Product Containers
 Packaging and Labeling
 Finished Goods – Warehouse Distribution Control Records
 Stability
 Complaint File

ACTIVITIES:

A. Enumerate the important GMP’s in the following areas

1. Production/Manufacture of

a. Liquids
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b. Solids

c. Semisolids

d. Parenterals/Sterile Preparations

2. Quality Control Area

3. Warehouse Department
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B. Give the different kinds of contamination. Discuss how each will affect the quality

of the products. Give one example for each.

C. By means of a schematic diagram, trace the flow of materials and personnel inside the
Warehouse area.

Conclusion: ____________________________________________________________

______________________________________________________________________

______________________________________________________________________

___________________________________________________________---_________
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ACTIVITY NO. 3

STICKERS

Name:__________________________ Date:_______________________

OBJECTIVES:

1. To identify the different colored stickers.

2. To know the purpose of each colored stickers.

TOPICS FOR DISCUSSION:

1. Different kinds of stickers used.

2. Purpose and importance of stickers.

ACTIVITIES:

A. Color the boxes according to the color of the stickers found in the
Production/Warehouse Areas. Write the type of each sticker beside it.

B. Identify the materials to which the different types of stickers are used.
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C. Give the purpose of each sticker.

Conclusion: ________________________________________________________________

__________________________________________________________________________

__________________________________________________________________________

__________________________________________________________________________
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ACTIVITY NO. 4

DOCUMENTATION

Name:__________________________ Date:_________________________

OBJECTIVES

1. To familiarize with the different systems used in the documentation.

2. To learn how to formulate the documents.

TOPICS FOR DISCUSSION:

1. Documents used in the Production Area

2. Documents used in the Quality Control Area
3. Raw Material and Finished Product Monographs
4. Examples of Monographs (USP/BP)

Sample Documents

RAW MATERIAL MONOGRAPH

Raw Material MANNITOL* Date ________________

SPECIFICATIONS

Description Orthorthrombic needles from alcohol with sweetish taste.

Identification Infrared Absorption <197 K>
Melting Range 165° – 169°, with softening at a lower temperature <741>
Specific Rotation +137° - +145° <781S>
Loss on Drying NMT 0.3% of its weight. <731>
Chloride 0.007% <221>
Sulfate 0.01% <221>
Arsenic 1 ppm. Method // <221>
Reducing Sugars Not more than a very slight precipitate is formed.
Assay NLT 96.0% and NMT 101.5% of C6H14O6

*Mannitol USP 30 (Vol. 3, 2007)

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FINISHED PRODUCT MONOGRAPH

Product Name: ATROPINE SULFATE INJECTION* Date ___________________

Strength:_______________________________

SPECIFICATIONS

Description Clear, colorless, sterile solution.

Identification Thin-layer Chromatographic Identification Test<201>

Bacterial Endotoxins NMT 55.6 USP Endotoxin Units per mg of Atropine

Sulfate <85>

pH 3.0 – 6.5 <791>

Other Requirements It meets the requirements under injections <1>

Assay NLT 93.0 percent and NMT 107.0 percent of the

labeled amount of Atropine Sulfate.

*Atropine Sulfate Injection USP 30 (Vol. 2, 2007)

ACTIVITIES:

A. Enumerate the different documents found in the

A. Production Area

B. Quality Control Area

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B. Using the USP/NF as reference, fill out the Quality Control Monograph of the
product assigned to you.

RAW MATERIAL MONOGRAPH

Raw Material __________________________________ Date ______________________

Strength

SPECIFICATIONS

Description

Identification

Limit Tests

Assay

PROCEDURE:

___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________
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FINISHED PRODUCT MONOGRAPH

Product Name _______________________________ Date _____________

SPECIFICATIONS

Description

Identification

Limit Tests

Assay

PROCEDURE:

_________________________________ _____________________________________

_______________________________________________________________________

_______________________________________________________________________

_______________________________________________________________________

_______________________________________________________________________

Conclusion: _____________________________________________________________

_______________________________________________________________________

_______________________________________________________________________

_______________________________________________________________________
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ACTIVITY NO. 5

LINE CLEARANCE

Name:__________________________ Date:______________

OBJECTIVES:

1. To understand the meaning and purpose of a line clearance.

2. To identify the areas where line clearances are applied.
3. To determine the activities done in a line clearance.

TOPICS FOR DISCUSSION:

1. Good practices in Production and Quality Control (Work Area, Personnel,

Machines/Equipment)
2. Checks done in processing operations (for intermediate and bulk products)
3. Checks done fir packaging operations.

ACTIVITIES:

List down the activities done in doing a line clearance for the following areas:

1. Dispensing Area

2. Compounding Area for Liquids

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3. Compounding Area for Liquids

4. Filling Area
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5. Labeling Area

6. Packaging Area

Conclusion: ______________________________________________________________

_________________________________________________________________________

_________________________________________________________________________

_________________________________________________________________________

_________________________________________________________________________

__________________________________________________________________________

__________________________________________________________________________
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ACTIVITY NO. 6

MANUFACTURE OF PHARMACEUTICALS

Name:__________________________ Date:_______________

OBJECTIVES:

1. To discuss the following of manufacture of each of the different drug delivery systems
using a schematic diagram.
2. To identify the equipment used in the manufacture of the pharmaceuticals.

TOPICS FOR DISCUSSION:

1. Product Formulation
2. Equipment Used
3. Flow of manufacture
4. Packaging and Storage

ACTIVITIES:

A. Cut out and paste pictures of equipment used in the manufacture of the fallowing

1. Solutions/ Syrups 6. Parenterals

2. Suspensions 7. Capsules
3. Emulsions 8. Tablets
4. Creams/ Ointments
5. Transdermal Drugs

Note: Please attach here your output.

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B. Submit samples of formulations of the different dosage preparations above.

(Use references such as books and electronic resources)

Conclusion: __________________________________________________________

____________________________________________________________________

____________________________________________________________________
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ACTIVITY NO. 7

SAMPLING AND INSPECTION –OF DEFECTS

Name:__________________________ Date:____________

OBJECTIVES:

1. To determine the defects found on closures and bottles.

2. To identify and describe the different kinds of defects seen on closures
and containers.

TOPICS FOR DISCUSSION:

1. Definition of Terminologies

 Sample
 Sampling
 Sampling Plan
 Inspection
2. Different Kinds of Defects
3. Sampling Plans

ACTIVITIES:

A. Inspection of Closures and Bottle Finish

1. Bring the different kinds of bottles with closures.

2. Draw and identify the various bottle finishes and the closure most suitable for
each design.
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_______________________________________________________
Critical Defects
These are_______________________________________________________
hazardous to users and completely unusable because they are freaks or did not fill the
mo. Identify all defects udder Major Defects and define each d
_______________________________________________________

_______________________________________________________

_______________________________________________________
.
_______________________________________________________

AQL (Acceptance Quality Level = 0%

r
a
c
k
s
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Major Defects

These are defects that materially reduce the usability of the container or its contents.

*Identify all defects udder Major Defects and define each.

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

AQL (Acceptance Quality Level) = 0%

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Minor Defects

These are defects that do not affect the usability of the container, but deduct from its
appearance or acceptability to the container. Identify all defects udder Major Defects and
define eachAQL (Acceptance Quality Level) = >5%

*.

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

AQL (Acceptance Quality Level) = 0%

Conclusion:
________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________
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ACTIVITY NO. 8

SAMPLING AND SAMPLING PLAN

Name:_______________________ Date:_______________

OBJECTIVES:

1. To determine the number of samples required in a sampling plan.

2. To demonstrate the square root sampling plan.

TOPICS FOR DISCUSSION:

1. Definition of Terminologies

 Sample
 Sampling
 Sampling Plan
 Inspection
2. Different Kinds of Defects
3. Sampling Plans

ACTIVITIES:

Sampling and Sampling Plan

1. Gather together all bottles brought by each group.

2. Group them according to appearance, color, size, and brand.
3. Count the total number of units per group. This will constitute the batch size (N).
4. Find the sample size (n) by using the square root system.

Square Root System: Separate Paper for the Table

n = √N+1
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Show your computations here. (Three separate sheets of paper provide )

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Conclusion: _____________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
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ACTIVITY NO. 9

PRODUCTION CONTROL – IPQC FOR SOLIDS

Name:__________________________ Date:_______________

OBLECTIVES:

1. To demonstrate how weight variation of uncoated tablets is performed.

2. To determine how thickness of tablets is tested using a caliper.
3. To learn how to determine tablet hardness using a hardness tester.
4. To determine the proper disposition after the evaluation of the results.

TOPICS FOR DISCUSSION:

1. In-Process QC for each dosage form:

a. Principle Involved
b. Official Requirements

2. Finished Product Quality Control Evaluation

ACTIVITIES:

Materials 20 pieces uncoated tablets caliper

hardness tester forceps
analytical balance

A. Weight Variation of Tablets

1. Weigh individually 20 whole tablets in suitable balance that can measure a fraction of
mg.
2. Determine the minimum and maximum weights.
3. Indicate these by writing L and H respectively besides the weight of the tablet.
4. Calculate the average weight.
5. Using current USP limits, calculate the tolerance limits for the average
6. Weight obtained.
7. Examine the individual weights for any weight that is outside the limits.
8. If there are more than one tablet with weight outside the limits, indicates
9. This by writing L1, L2, or H1, etc.
10. Write disposition.
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Weight of 20 individual tablets

1. 11.

2. 12.

3. 13.

4. 14.

5. 15.

6. 16.

7. 17.

8. 18.

9. 19.

10. 20.

B. Tablet Thickness

1. Take ten (10) whole tablets.

2. With a caliper, measure the thickness of each tablet in mm.
3. Note the lowest and the highest of each tablet in mm.
4. Determine the average thickness.

Product Name _________________________________

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Specification of the Tablet:

C. Tablet Hardness

Procedure:
1. Take the same ten (10) whole tablets.
2. Determine the hardness of each tablet as follows:
3. Place the tablet on its edge between the anvil and the plunger
4. Enter it perpendicular to the pressing surface.
5. With only sufficient pressure to hold the tablet in position, note the pointer reading.
6. Apply pressure at slow constant rate until the tablet breaks.
7. The difference between the initial and the final readings is the pressure in kilogram
required to fracture the tablet.
8. The spring of the hardness tester should never be left under tension as this will
ultimately affect the initial reading.
9. The crushing surface should be cleaned before each test to ensure correct application
of pressure.
10. Lubricate the threads and end of the screw spindle to assure free movement.
11.Determine the average.

Product Name _________________________________

Initial Reading ______________________________

Calculation:

Hardness (kg) = Final - Initial Reading

Disposition:

Conclusion_____________________________________________________________
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_______________________________________________________________________

ACTIVITY NO. 10

SAMPLING AND INSPECTION – 100% INSPECTION

100% Inspection
Name:__________________________ Date:_______________
1. Take the remaining ten tablets from the previous activity.
OBJECTIVES:
2. Inspect each one for any defects.
3. determine
1. To Record your observations
the number using the
of samples table in
required below
a sampling plan.
2. To determines the advantages and disadvantages of doing 100%

ACTIVITIES:

Sample
 Sampling
 Sampling Plan
 Inspection
1. Different Kinds of Defect

TOPICS FOR DISCUSSION:

1. Definition of Terminologies

0
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Calculation: Total Number of Defects x 100 = % Defects

Total Number of Units

Remarks:

Conclusion:
_________________________________________________________________

_________________________________________________________________

_________________________________________________________________
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ACTIVITY NO. 11

PRODUCTIION CONTROL – IPQC FOR LIQUIDS

Name:__________________________ Date:_______________

OBJECTIVES:

1. To acquire the skills in monitoring the volume fill of liquids during production filling
2. To determine the pH of the solution using the pH meter and how to adjust it.

TOPICS FOR DISCUSSION:

1. In-Process QC for each dosage form:

a. Principle Involved
b. Official Requirements
2.Finished Product Quality Control Evaluation

ACTIVITIES:

Materials: graduated cylinder

pH meter

A.Volume Fill Monitoring

1. Pick out about 5 samples of filled bottles randomly from the filling line.
2. Measure the volume fill of each bottle using the graduated cylinder.
3. Check against the label claim of the product.
4. Record the volumes in the monitoring sheet
5.
6. .
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Remarks:

Disposition:

A. pH Monitoring

1. Withdraw a few mL of the compounded solution (prior to qs) and test for the pH
using the pH meter.

2. Check the result against the required pH of the solution.

3. Adjust the pH of the solution, if necessary.

4. After adjustment of the pH, test again using the pH meter.

5. Record the result.

Product Name: ________________________________________________________

pH Requirement: ______________________________________________________

pH at First Sampling:
___________________________________________________

pH at Second Sampling (after adjustment):

__________________________________

Remarks:
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Disposition:

Valuation

Conclusion: ________________________________________________________

___________________________________________________________________

___________________________________________________________________
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Note : this sheet is detachable

Evaluation of Students Performance in Pharmaceutical Manufacturing

laboratory

Name of Student:
____________________________________________
School :
_____________________________________________
Preceptor Name :
_____________________________________________
Name of Establishment:
________________________________________
Address:
_____________________________________________
Inclusive Dates: _____________________________________________
Direction : this evaluation tool is designed to assess the competency of the
pharmacy students in the delivery of the basic pharmaceutical services. (
using the scale below, check the appropriate number next to each
indicator.

Rating Scale:
5- Excellent Requires no supervision. Performs
functions with a high degree of
competence

4- Very Good Requires minimal supervision. Performs

functions with a satisfactory degree of
competence

3- Good Requires occasional supervision.

Performs functions acceptable
competence

2- Fair Needs consistent supervision with limited

ability

1-Poor Cannot perform functions without

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supervision

NA – Not Applicable The indicator is not applicable

INDICATORS 5 4 3 2 1 NA
A. PERSONAL AND
PROFESSIONAL ATTRIBUTES
1. Reliability: Fulfill attendance
requirements; correctly
completed all assignments
2. Maintain professional image

3. Time management. Uses time

effectively and efficiently in the
performance of assigned tasks.
4. Self -Initiative. Initiate
professional activities and
interactions with staff, health
professionals, and colleagues;
utilizes time in pursuing
knowledge and experience
5. Independence/ Assertiveness.
Are self -directed in undertaking
responsibilities; seeks
appropriate clarification, but
require minimal supervision in
completing assignment,
articulate own view point.
6. Organized Plans. Use own and
other peoples time effectively
and efficiently; are systematic
and methodical in approaching
activities; are well prepared.
7. Decision Making. Use good
judgement, seek out and utilize
important facts and information;
recognize and evaluate available
alternatives.
B. Manufacturing and Industrial 5 4 3 2 1 NA
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Practice
1. Perform activities in the different
process involved in the
manufacturing of drugs such as,
but not limited to production, QA
and QC testing, packaging,
dispensing of raw materials,
warehousing, inventory,
documentation, and research &
development
2. Have a working knowledge in
securing and maintaining license
to operate for manufacturing and
pharmaceutical firms
3. Acquire knowledge in the
marketing and distribution of
pharmaceuticals
4. Learn the processes involved in
getting product registered in
government regulatory agencies

Goodluck !!!

References:

Ansel, H.,N. Popovich, L. Allen. Pharmaceutical Dosage Forms and Drug Delivery
Systems . 8th ed. Philadelphia. Lippincott Williams and Wilkins. 2005

Osi, M., Jose, D and T. Anonuevo. Laboratory Manual in Manufacturing and

Quality Control of Drugs and Cosmetics.

Revision Committee. United States Pharmacopeia 31st ed. And National Formulary
25th ed. Asian Edtion. USP convention, 2008
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WHO. Quality Assurance of Pharmaceutical. A compendium on Guidelines

and related materials. 2007