(Pharmaceutical) : Quality Control & Quality Assurance

Quality Control
Diploma
Quality Control & Quality First Lecturer
Assurance Quality
(Pharmaceutical)
(2019/2020)
Prof. Dr. Mokhtar M. Mabrouk, D.Q.C. 2/27/2021 Prof. Dr. Mokhtar M. Mabrouk, D.Q.C. 2/27/2021
The poor qualities of products (medicines

etc .) and/or services (facilities, etc ) are
not only a health hazard, but also a waste of
money for both government and individual
consumers.
Therefore, the maintenance of quality with The practice of quality being approached
continuous improvement in facilities is very through the concept of total quality
important in all industrial aspects including management (TQM) system which is aimed at
pharmaceutical industries. prevention of defects rather than detection
of defects.
The concept of total quality control refers to Although the responsibilities for assuring
the process to produce a perfect product by a product quality belong primarily to quality
series of measures requiring an organized assurance personnel, it involves many
effort by the entire company to prevent or department and disciplines within a
eliminate errors at every stage in production. company. To be effective, it must be
supported by a team effort.
The assurance of quality of the product

Quality must be built into a pharmaceutical
depends on more than just proper sampling
product during product and process design
and adequate testing of various components
and it is influenced by the physical plant
and finished dosage forms (products).
design, space, ventilation, cleanliness and
sanitation during routine production(1).
Prime responsibility of maintaining the Quality assurance personnel must establish

product quality during production rests with control or check points to monitor the quality
the manufacturing department. of the product as it is processed and up to
completion of manufacturing.
This begins with raw materials and Quality assurance policy, therefore, become
component testing and includes in-process the most important goal of pharmaceutical
packaging, labeling and finished product industry. The concept of quality assurance
testing as well as batch auditing and stability and quality control develops and follows
monitoring. standard operating procedures (SOP) directed
towards assuring the quality, safety and
efficacy.
In USA, as the Food and Drug Administration
(FDA) has a mandate that the marketed drug
World Health Organization (WHO) has issued a
primary or fundamental regulation to
product be safe effective, the drug product
pharmaceutical industries entitled good must meet certain criteria for quality and
manufacturing practice (GMP) for purity.
pharmaceuticals. Based on WHO GMP, many
countries have formulated their own
requirements for GMP.
The FDA has issued regulatory guidelines According to FDA regulations, a drug product
known as current good manufacturing that does not meet the GMP requirements is
practice (cGMP) and good laboratory practice considered unacceptable(1,2).
(GLP) to assure the public that the marketed

drug product has been properly
manufactured and clinically tested
respectively.
Thus, quality is critically important ingredient

to organizational success today which can be The basis of this approach is the
achieved by total quality management organizational units should be working
(TQM). harmoniously to satisfy the customer. Since
the customer s needs are in constant flux, the
organization must strive to continuously
improve its system and practices.
Quality
The TQM perspective views quality as the

central purpose of the organization, in
contrast to the focus on efficiency advocated
by the operational perspective(3).
Quality Quality has been defined in different ways by
Quality is a very commonly used term but the quality gurus as conformance to
can be described very vaguely. Quality is an standards or specifications; fitness for use;
unusually slippery concept, easy to visualize meeting customer s requirements or
and yet difficult to define. It is a matter of expectations; delighting the customer etc.
feeling and the definition varies from person
to person depending on the perspective in
which defined
The code defines quality therefore as the The quality of a product is its degree of
totality of features and characteristics of a possession of these characteristics, designed
product/service that bears on its ability to and manufactured into it which contribute to
satisfy given needs(2). the performance and the desired function of
the product.
Thus the quality, for a product or service, has These ensure that the product or the services
two aspects, both of which together make for meets the needs of the user. The second
an appropriate definition of the term. The aspect concerns the absence of deficiencies
first relates to the features and attributes of in the product.
the product or service.
The eight dimensions of quality, which is a

critically important ingredient to
organizational success, are as follows.
1-Performance:
Product s primary operating characteristics. 3-Reliability:
2-Features: A probability of not malfunctioning during a specified

period.
Supplements to a product s basic functioning
4-Conformance:
characteristics.
The degree to which a product s design and operating
characteristics meet established standards.
The quality of pharmaceuticals has been a
5-Durability: A measure of product life. concern of the World Health Organization
6-Serviceability: The speed and ease of (WHO) since its inception. The supply of
repair. essential medicines of good quality was
7- Aesthetics: How a product looks, feel, identified as one of the prerequisites for the
tastes and smells. delivery of good health care.
8-Perceived quality: As seen by a customer.

Yet the World Health Assembly continues to In recent years counterfeit products have
express great concern about the quality, infiltrated certain markets in disquieting
safety and efficacy of medicines, particularly proportions.
those products or active pharmaceutical
substances imported into, or produced in,
developing countries.
Since the founding of WHO, the World Health The quality of medicinal and related
Assembly has adopted many resolutions products is the sum of all factors which
requesting the Organization to develop contribute directly or indirectly to the safety,
international standards, recommendations efficacy and acceptability of the product.
and instruments to assure the quality of Quality must be built into the product
medicines, whether produced and traded during research, development and
nationally or internationally. production.
Quality control is a process employed to The basic goal of quality control is to ensure
ensure a certain level of quality in a product that the products, services, or processes
or service. It may include whatever actions a provided meet specific requirements and are
business deems necessary to provide for the dependable, satisfactory, and fiscally sound.
control and verification of certain
characteristics of a product or service.
Essentially, quality control involves the

examination of a product, service, or process
If a problem is identified, the job of a quality
for certain minimum levels of quality. The
control team or professional may involve
goal of a quality control team is to identify
stopping production temporarily. Depending
products or services that do not meet a
on the particular service or product, as well
company s specified standards of quality.
as the type of problem identified, production
or implementation may not cease entirely.
Once such problems are overcome, the

Usually, it is not the job of a quality control product, service, or process continues
team or professional to correct quality issues. production or implementation as usual.
Typically, other individuals are involved in the
process of discovering the cause of quality
issues and fixing them.
Quality control can cover not just products,

services, and processes, but also people. If a company has employees that don t have
Employees are an important part of any adequate skills or training, have trouble
company. understanding directions, or are
misinformed, quality may be severely
diminished.
Often, quality control is confused with quality
When quality control is considered in terms
assurance. Though the two are very similar,
of human beings, it concerns correctable
there are some basic differences. Quality
issues. However, it should not be confused
control is concerned with the product, while
with human resource issues.
quality assurance is process oriented.
Even with such a clear-cut difference defined, Simply, quality assurance ensures a product
identifying the differences between the two can
or service is manufactured, implemented,
be hard. Basically, quality control involves
created, or produced in the right way; while
evaluating a product, activity, process, or
service. By contrast, quality assurance is quality control evaluates whether or not the
designed to make sure processes are sufficient end result is satisfactory.
to meet objectives.
Quality Assurance (QA) Quality Assurance (QA)
(QA) is a process-centered approach to ensuring

that a company or organization is providing the
best possible products or services. It is related to
quality control, which focuses on the end result,
such as testing a sample of items from a batch
after production.
Although these terms are sometimes used Among the parts of the process that are
interchangeably, quality assurance focuses on considered in QA are planning, design,
enhancing and improving the process that is development, production and service.
used to create the end result, rather than
focusing on the result itself.
The Shewhart Cycle
There are many QA tools that organizations One of the most popular tools is called the
can use and that will help guide them Shewhart cycle, which was developed by Dr.
through the steps that are needed to ensure W. Edwards Deming, a 20th-century
that their processes are as efficient and American management consultant who
named the tool after his associate, Walter A.
productive as possible.
Shewhart.
This cycle for quality assurance consists of four

steps: Plan, Do, Check and Act (PDCA). At the
end of Shewhart cycle, which also is called the
Deming cycle or PDCA cycle, the steps are
repeated to ensure that the process is being
evaluated and improved on a constant basis.
The first step of the PDCA cycle, Plan, the The second step, Do, is when the processes
organization should establish its objectives or changes are developed and tested. In the
and determine the processes or changes in third step, Check, the processes or changes
the processes that are required to deliver the are monitored and evaluated to determine
desired results. whether the results are meeting the
predetermined objectives.
Total quality management
The final step, Act, is when actions that are Different experts have attempted various
definitions to the concept of total quality
necessary to achieve the desired
management (TQM) from time to time. It may
improvements are fully implemented into the
be defined as-
process. The cycle can then be repeated, It is continuously meeting agreed customer
beginning with new objectives being requirements at the lowest cost by realizing the
planned. potential of all employees .
It may also be defined as performance
superiority in delighting customers. The
means used are people, committed to
employing organizational resources to
provide value to customers, by doing the
right things right the first time, every time(2,4).
Therefore, total quality management (TQM)

means:
1-Satisfying customers first time, every time; 3-A style of working, a culture more than a
2-Enabling the employees to solve problems management technique;
and eliminate wastage; 4-Philosophy of continuous improvement,

never ending, only achievable by/or through
people.
British Quality Association offers three

alternative definitions of TQM:
1-The first focuses on soft quality -2-The second focus on hard

characteristics and may be defined as production/operation management type of
integrative management concept for view involving less discretion for employees.
continuously improving the quality of
good/services delivered through the
participation of all levels and functions.
-It may be defined as a set of techniques and -3-The third definition is a mixture of hard
procedures used to reduce or eliminate and soft comprising 3 features and obsession
variation from a production/process or with quality, need for a scientific approach
service delivery system in order to improve and the view that all employees are involved
efficiency, reliability and quality. in this process.
The key elements of the TQM approach are:
1- Focus on the customer: It is important to 2- Employee Involvement: Since the quality is

identify the organization s customers. considered the job of all employees.
External customers consume the Employees should be involved in quality
organization s product or service. Internal initiatives.
customers are employees who receive the
output of other employees.
Front line employees are likely to have the 3-Continuous improvement: The quest for
closest contact with external customers and quality is a never-ending process in which
thus can make the most valuable people are continuously working to improve
contribution to quality. Therefore, employees the performance, speed and number of
must have the authority to innovate and features of the product or service.
improve quality.
Managing total quality
Continuous improvement means that small, The most pervasive approach to managing
incremental improvement that occurs on a quality has been called total quality
regular basis will eventually add up to vast management (TQM) a real and meaningful
improvement in quality. effort by an organization to change its whole

approach to business to make quality a guiding
factor is everything the organization does.
The major ingredients in TQM are
1. Strategic commitment: The start point for

TQM is a strategic commitment by the First the organizational culture must change
management. to recognize that quality is not just an idea
but is instead an objective goal that must be
pursued.
Thus, without a commitment from top
Second, a decision to pursue the goal of quality
management, quality improvement will
carries with it some real costs for expenditures
prove to be just a slogan or gimmick, with
such as new equipments and facilities. little or no real change.
2. Employee involvement: Employee By definition, then employee involvement is

involvement is another critical ingredient in
critical component in improving quality.
TQM. Virtually all successful quality
enhancement programs involve making the
person responsible for doing the job
responsible for making sure it is done right.
3. Materials: Another important part of TQM 4. Technology: New forms of technology are
is improving the quality of the materials that also useful in TQM programs. Investing in
organization use. higher-grade machine capable of doing jobs
more precisely and reliably often improves
quality.
5. Method: Improved methods can improve

product and service quality. Methods are The professional, social and legal
operating systems used by the organization responsibilities that rest with the
during the actual transformation process. pharmaceutical manufacturers for the
assurance of product quality are tremendous.
It should be realized that no amount of dosage form
It is only through well organized, adequately
testing and control can maintain and assure product
staffed accurately performed process and
quality unless good manufacturing practices (GMP)
dosage form control before, during and after are implemented systematically and process control is
production that adequate quality assurance practiced rigorously. Product quality must be build
of the product can be achieved. into and not merely tested in the product.
Manufacturer responsibilities
a- Control the sources of product quality
The pharmaceutical manufacturer assumes variation, namely
the major responsibility for the quality of his materials,
products. machines,
methods and
. men.
b-Ensure the correct and most appropriate d-To assure product stability and to
manufacturing and packaging practices. perform other activities related to product

quality through a well-organized total
c-To assure that the testing results are in
quality assurance system.
compliance with the standards or
specifications.
For the total quality management system to First, control decisions must be based solely
function effectively, certain basic on considerations of product quality.
operational rules should be established and
should always prevail.
Second, the operation must adhere rigidly to Third, the facilities, funds for personnel and
the established standards or specifications as environment necessary for personnel to
determined by systemic inspection, sampling perform their responsibilities effectively
and testing, and should constantly strive for should be adequately provided.
improving the levels of the current standards
or specifications.
Last but not the least, the control decisions Because the control decision can involve the
should be independent administratively, and health of the consumer and the reputation
they must not yield to or be overruled by, of the pharmaceutical manufacturer, the
production or marketing under any climate necessary for making judicious
circumstances. decisions is essential.
Implementation of Q. C. System
In times of major disagreements, the control Quality assurance (QA) and quality control
decision should be subjected to review only (QC) develop and follow standard internal
at the highest level of management. operating procedures directed toward
assuring the quality, safety, purity and
effectiveness of the drug supply.
The FDA has issued a primary regulation to

industry titled Current Good Manufacturing
Practice in Manufacture, Processing or
Holding of Human and Veterinary Drugs
(CGMPs or GMPs).
Numerous other guidelines have been
issued relative to specific dosage forms and These guidelines also serve as the basis for
operations which give increased guidance compliance investigations conducted by
and direction to the industry in order for the FDA and are used in their inspections
them to plan for and to remain in of facilities and operations.
compliance.
In order to implement an effective QC Next, real-world data must be collected (for

program, an organization must first decide example, the percentage of units that fail)
which specific standards the product or and the results reported to management
service must meet. Then the extent of QC personnel. After this, corrective action must
actions must be determined (for example, be decided upon and taken (for example,
the percentage of units to be tested from defective units must be repaired or rejected
each lot). and poor service repeated at no charge until

the customer is satisfied).
If too many unit failures or instances of Finally, the QC process must be ongoing to
poor service occur, a plan must be devised ensure that remedial efforts, if required,
to improve the production or service process
have produced satisfactory results and to
and then that plan must be put into action.
immediately detect recurrences or new
instances of trouble.
which ensure that the necessary and

Quality Control is that part of Good
relevant tests are, in fact, carried out, and
Manufacturing Practice which is concerned
that materials are not release for use, nor
with sampling, specification and testing, and
products released for sale or supply, until
with the organization, documentation and
their quality has been judged to be
release procedures
satisfactory.
So, quality control is about testing products, There are many methods and techniques
and the materials which are used in making available to identify, to characterize, to
those products, but it is significantly more isolate, to assay and to check the purity of
than that. the materials used, and the products
produced by, the industry.
These techniques may be chemical, physical,

electronic, microbiological or biological.
They can range from simple, relatively (spectroscopic, chromatographic,
crude, traditional volumetric or gravimetric calorimetric, voltammetric,
methods, to modern instrumental immunochemical, etc.) of ever-increasing
techniques sensitivity and precision.
As is implicit in the definition quoted above,

A wide range of immensely powerful
to be effective in controlling (and ultimately
analytical tools is now available for use by
assuring) the quality of medicinal and like
the pharmaceutical quality controller. It is
products ,
however important to remember that, like
all tools, their ability to achieve the desired
ends depends very largely on how they are
used.
these tools must be employed in the context In other words, quality control is laboratory
of an organization and a system which testing conducted in the context of good
embraces the sampling of materials and manufacturing practice (GMP), and more
products, the establishment of appropriate
specifically in accordance with good control
specifications and test methods, and well-
laboratory practice (GCLP).
controlled release/reject mechanisms.
In-Process Control
In-process controls (IPC) are checks that are The function of in-process controls is
carried out before the manufacturing monitoring and if necessary adaptation of
process is completed. the manufacturing process in order to comply
with the specifications. This may include
control of equipment and environment, too.
In-process materials should be tested for

identity, strength, quality and purity as
appropriate and approved or rejected by the
Quality Control unit during the production
process.
Written procedures should be established and

followed that describe the In-process controls
Rejected in-process materials should be and tests as specified:
identified and controlled under a quarantine Tablet or capsule weight variation,
system designed to prevent their use in Disintegration time,
manufacturing. Content uniformity and homogeneity,

Dissolution time and rate,
Clarity, completeness or pH of solutions.
In-process controls may be performed in

In-Process Control
regular intervals during a process step (e.g. In-Process Control refers to the checks
tabletting, encapsulation) or at the end of a performed during an activity (it can be
process step (e.g. granulation, blending). The manufacturing or packing) in order to
objectives of in-process control are both monitor and if necessary to adjust the
quality control and process control. process and/or to ensure that the
intermediate or finished product conforms
to its specification.
The control of equipment and environment
Frequency of the in process checks need to
may also be regarded as the part of in
be realistic. By carrying out in process
process control.
checks one can assure the product quality.
In process checks are vital as
In process quality check is designed to
manufacturing activity itself and the same
provide early warning for quality or other
shall be performed at regular intervals.
problems arising during production.
In Other words it is intended to provide a

Analytical control must be able for in-
snap shot of the quality of the product
process control of products or
manufactured at the factory. The objective
intermediates. In process control is
of in process checks are both quality control
identified at the critical operational steps.
and process control.
the in-process limits (alert or action levels) In-process critical testing depending on the
are limits or specifications which are dosage form being manufactured. Sterile
more restrictive than the final acceptance products receive the most critical in-process
level, these levels are giving an early control and testing in order to insure a
warning of conditions which could lead to
finished product which is sterile and free
out-of-control situation and allow timely
of microbial contamination.
corrective action to be taken before this
occurs.
Quality Control Function Analytical Control Unit :
The quality control function in an The analytical control laboratory is

organization normally consists of at least responsible for testing and approving raw
two primary units materials, work in-process and finished
1- Analytical control unit product.
2- Inspection control unit
The laboratory must be : 2- Will equipped with instruments which
1-Staffed with trained personnel allow accurate analysis
experienced to perform complex analysis 3- Detailed specifications of test methods
required to evaluate the acceptance of a must be available. The specification must

include the limits for acceptance or
product
rejection for each parameter.

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Quality Control

The poor qualities of products (medicines

The assurance of quality of the product

Prime responsibility of maintaining the Quality assurance personnel must establish

practice (cGMP) and good laboratory practice considered unacceptable(1,2).

(GLP) to assure the public that the marketed

Thus, quality is critically important ingredient

The TQM perspective views quality as the

The eight dimensions of quality, which is a

Product s primary operating characteristics. 3-Reliability:

2-Features: A probability of not malfunctioning during a specified

The quality of pharmaceuticals has been a

5-Durability: A measure of product life. concern of the World Health Organization

repair. essential medicines of good quality was

tastes and smells. delivery of good health care.

8-Perceived quality: As seen by a customer.

Essentially, quality control involves the

Once such problems are overcome, the

Quality control can cover not just products,

Quality Assurance (QA) Quality Assurance (QA)

(QA) is a process-centered approach to ensuring

This cycle for quality assurance consists of four

Total quality management

Therefore, total quality management (TQM)

2-Enabling the employees to solve problems management technique;

and eliminate wastage; 4-Philosophy of continuous improvement,

British Quality Association offers three

1-The first focuses on soft quality -2-The second focus on hard

1- Focus on the customer: It is important to 2- Employee Involvement: Since the quality is

Managing total quality

improvement in quality. effort by an organization to change its whole

The major ingredients in TQM are

1. Strategic commitment: The start point for

2. Employee involvement: Employee By definition, then employee involvement is

5. Method: Improved methods can improve

manufacturing and packaging practices. perform other activities related to product

The FDA has issued a primary regulation to

operations which give increased guidance compliance investigations conducted by

them to plan for and to remain in of facilities and operations.

In order to implement an effective QC Next, real-world data must be collected (for

each lot). and poor service repeated at no charge until

which ensure that the necessary and

These techniques may be chemical, physical,

crude, traditional volumetric or gravimetric calorimetric, voltammetric,

methods, to modern instrumental immunochemical, etc.) of ever-increasing

techniques sensitivity and precision.

As is implicit in the definition quoted above,

In-process materials should be tested for

Written procedures should be established and

identified and controlled under a quarantine Tablet or capsule weight variation,

system designed to prevent their use in Disintegration time,

manufacturing. Content uniformity and homogeneity,

In-process controls may be performed in

In Other words it is intended to provide a

Quality Control Function Analytical Control Unit :

The quality control function in an The analytical control laboratory is

1- Analytical control unit product.

2- Inspection control unit

1-Staffed with trained personnel allow accurate analysis

experienced to perform complex analysis 3- Detailed specifications of test methods

required to evaluate the acceptance of a must be available. The specification must

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