Introduction to Quality Control

Microbiology
in Pharmaceutical and Food Industries

Mohamed Abo-Elgheit
BSc. Microbiology and Chemistry,
TQM Diploma AUC,
MBA AASTMT
mhmd.aboelgheit@gmail.com
Learning Objectives
1. To understand the role of Quality Control Microbiology Lab in the
pharmaceutical and the food industries.

2. To get an overview on The Management System of a Quality

Control Microbiology Lab.

3. To be familiar with microbiological tests and processes.

4. To get to know career path and qualifications of the QC

microbiologist.
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This Training Course Will help you…
1. Be ready for an interview as a fresh graduate for the QC
microbiologist job.

2. Easily understand and grasp further topics on the main subject of

the course.

3. Deepen your understanding of GMP, GLP and Quality in relation

to Microbiological Analysis.

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Course Content
• PART 1 QC Microbiology Lab in Food and Pharma

• PART 2 Activities in Microbiology Lab

• PART 3 QC Microbiology-related topics

• PART 4 To be a QC Microbiologist

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PART 1
Quality Control Microbiology Lab

I. What is Microbiology?

II. What is Microbiological QC? Role? Scope?

III. QC Microbiology Lab Design, Equipment and System

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What is Microbiology?
• Microbiology is the study of microscopic
organisms

• The term microbiology was coined by Louis

Pasteur.

• Microbiology emerged as a science since the

invention of powerful lenses and microscopes.

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Branches of Microbiology

• Microbiology is the study of microscopic

microorganisms:
• Bacteriology (the study of bacteria)
• Mycology (the study of fungi)
• Phycology (the study of algae)
• Virology (the study of viruses)

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 Microbiology in the Tree of Life

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Bacteria

• Bacteria are prokaryotic

single cell organisms

• Prokaryote == lack
nucleus, no nuclear
membrane around the
chromosomal DNA.

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Gram Stain and Cell Wall
Bacteria are 2 groups:
• Gram +ve Bacteria:
• High peptidoglycan (polysachharide) in
cell wall
• Retain the stain
• Gram –ve Bacteria:
• Low peptidoglycan
• High lipopolysaccharide in cell wall
• Don’t retain the stain

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Bacteria: Gram Stain and Cell Wall

Staphylococcus auresus

E. coli

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Bacteria: Aerobic vs. Anaerobic
• Aerobic bacteria utilize oxygen to make energy.

• Anaerobic bacteria don’t require oxygen to make their

energy so they can survive without oxgen.

• Some anaerobic bacteria cannot survive in presence of

oxygen, also called “obligate anaerobic bacteria”

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Fungi
• Fungi are a group of eukaryotic living organisms that
include, but not limited to, yeasts and molds.

• Eukaryote == has a true nucleus

• Yeasts: single cell eukaryotic organisms

• Molds: multicellular filamentous eukaryotic organism.

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Fungi: yeast and molds

Candidia albicans

Rhizopus sp.

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Normal Flora (Human Microbiome)
Staphlyococcus aureus

• Skin
• Upper Respiratory Tract

Escherichia coli

• Intestine

Lactobacillus spp.

• Vaginal Tract
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PART 1
Quality Control Microbiology Lab

I. What is Microbiology?

II. What is Microbiological QC? Role? Scope?

III. QC Microbiology Lab Design, Equipment and System

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What is Quality?
• Quality refers to the degree to which a set of
characteristics of a product (or service) fulfils requirement
(ISO 9000:2015)
• Quality is the totality of features and characteristics of a
product or a service that bear on its ability to satisfy stated
or implied needs (American Society of Quality)
• Quality is:
• Fitness for use
• Meeting (or exceeding) customer expectation
• Conformance to requirements / Standards/ Specifications
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What is Quality Control?
• With many products that a person uses or consumes a
Quality Standard/ Specs must be met for it to be
considered safe for the market.
• Quality Control is testing a sample of the product against
specifications, to ensure conformity:
• CONFORM = PASS = Meeting specification
• NONCONFORM = FAIL = Not meeting specification
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Microbiological Quality Control Scope
Allowing the microbiologists monitor and control microbial
content to ensure manufacturing of safe product:
1. Testing the product against microbiological
specifications
• Microbiological Analysis Tests
2. Studying the microorganisms associating with
manufacturing
• Environmental Monitoring and control

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Manufacturing flow chart and role of
Microbiological QC
Warehouse
RM Sampling RM Testing
Raw Material • EM QC Fail
(QC) (QC)

Manufacturing Dispensing
Finished Reject
• EM • EM QC PASS
Goods

FG Sampling FG Testing
QC PASS Release
(QC) (QC)

Reject QC Fail
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Microbiological QC scope

• Microbiological QC is concerned with:

• Sampling & Testing (RM, intermediate, FG)

• Release/ Reject (RM, FG)

• Environmental Monitoring (Dispensing, Manufacturing)

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PART 1
Quality Control Microbiology Lab

I. What is Microbiology?

II. What is Microbiological QC? Role? Scope?

III. QC Microbiology Lab Design, Equipment and System

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Good Manufacturing Practices (GMP)
• Good Manufacturing Practices (GMP) are a set of practices
which ensures that the products are consistently produced
and controlled according to the quality standards (WHO).

• GMP should be integrated into all steps of production.

• Areas where GMP impacts: facilities, equipment,

production process, etc.
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Good Laboratory Practices (GLP)
• Good Laboratory Practices (GLP) are a set of practices which
ensures reliability and reproducibility in the lab.

• Reliability  to how extent the results are trustworthy

• Reproducibility  the ability to get the same results when some

factors changes e.g. analyst change, equipment change, etc.

• Reliability + Reproducibility = = Quality of data / results

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Good Laboratory Practices (GLP) Pillars
(Not inclusive)
1. Lab Staff
2. Lab Design and Environment
3. Lab Equipment
4. Documentation System

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Lab Staff (Human Resources)
• The primary contributor to ensuring GLP.
• Qualifications: certificates and experiences
• Training:
• On-job
• Ongoing, regular.
• Microbiological skills:
• Colony counting
• Plate pouring
• Media Preparation
• Aseptic Technique
• Etc…

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Aseptic Technique
• Bacteria are everywhere. It is important to take measures to
avoid contaminating your work with undesired bacteria.
• Aseptic Technique is a technique used by microbiologists
when handling microbial cultures
Disinfecting of working areas, and hand sanitation
Use of flames to kill bacteria that may enter vessels
openings
Working Under Biosafety Cabinet

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Microbiology Lab Design and Environment

• Separation of Microbiology lab from the production area. WHY??

• Segregation of clean and dirty activities. WHY??

• Dedicated spaces for samples, media, reference

microorganisms.

• Disinfection and sterilization can be effectively done

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 Microbiology Lab Design
Microbiology
lab

Clean Areas Live Culture Areas

Washing Media
Sterilization Testing Growth Promotion
Preparation
Areas

MLT area Strain maintenance

Sterility Area Microbial Identification

PCR Area Decontamination Area

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Microbiology lab Equipment
(Not Comprehensive)
Generic Equipment Specific Equipment

Glassware Autoclave

Weighing balance Laminar Air Flow

pH meter Safety Cabinet

Filtration System Incubator

Oven Sample Homogenizer

Water Bath Microbial Identification System

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Autoclave (steam sterilization)
Steam
Sterilization
• Media
• Glassware
• Gowns

Decontamination
• Incubated
Cultures
• Contaminated
items

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Autoclave: mechanism

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Laminar Air Flow (LAF)

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Laminar Air Flow: air direction

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Microbiological Incubators

Bench Incubator Walk-in Incubator

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Lab Equipment: Calibration
• Measuring equipment used in
analysis should be calibrated
before using and at intervals.
• Calibration:
• Adjusting or standardizing your
equipment so it can give precise
and accurate measurements.
• It involves comparing your
equipment reading with another
calibrated equipment
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Lab Equipment: Performance Verification
• Additionally, equipment performing specific activities (e.g.
incubator), should be verified for its performance before
start use and at intervals.
• Performance Verification:
• A set of tests, inspections and assessments ensuring that an
equipment performs at intended by the manufacturer when
operating at your lab.
• To verify the performance of an incubator, you should study its
thermal distribution to ensure acceptable performance.

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 Mohamed Aboelgheit
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 Documentation System
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Procedure and Work Instructions
• Procedures are standard documentations of the critical
processes in the lab e.g. operation of autoclave, Media
Preparation.
• Procedure describes:
• The purpose of the process
• Responsibilities of each personnel involved in the process
• Detailing of the process activities.
• Procedure should be approved by an authorized personnel
(e.g. Lab Manager) prior being effective.
• Work Instructions/ Practices are just a simpler type of procedure.
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Records
• Records are documents generated by
applying procedures/ work instruction of
the processes.
• Records provide objective evidence on all
tasks done in lab e.g.:
• Media Preparation records
• Test performance and result records
• Equipment monitoring, calibration and
verification records
• Lab staff training records
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