Quality Control and Assurance in Relation to Preparation of Pharmaceutical Products
Session 7: Quality Control and Assurance in Relation to
Preparation of Pharmaceutical Products
Total Session Time: 120 minutes
Prerequisites
Learning Tasks
By the end of this session students are expected to be able to:
products
Resources Needed:
SESSION OVERVIEW
Activity/
Step Time Content
Method
1 05 minutes Presentation Introduction, Learning Tasks
15 minutes Presentation
2 Definition of Quality
Buzzing
10 Minutes Presentation
3 Importance of Quality
4 10 minutes Presentation Definition of Quality Control
15 minutes Presentation
5 Definition of Quality Assurance
20 minutes Presentation
6 QC/QA Comparisons
Brain storming
Functions of Quality Control Laboratory in
Presentation Relation to Preparation of Pharmaceutical
7
35 minutes Products
8 05 minutes Presentation Key Points
9 05 minutes Presentation Evaluation
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
SESSION CONTENTS
STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)
READ or ASK students to read the learning tasks and clarify
ASK students if they have any questions before continuing.
STEP 2: Definition of Quality (15 minutes)
Activity: Buzzing (5minutes)
ASK students to pair up and buzz on the following questions for 5 minutes
ALLOW few pairs to respond and let other pairs add on points not mentioned
WRITE their response on the flip chart/board
CLARIFY and SUMMARIZE by using the content below
The equipments used in facility based pharmaceutical preparation unit include the following
(Customer satisfaction). The ability of a product or service to satisfy the specific customer
needs. Achieved by conforming to established requirements and standards. Or alternatively
quality can be defined as; Is the attribute or collection of attributes appropriate for intended
use. Is the attribute or collection of attributes desirable for intended use?
EFFECTIVENESS – Meeting Customer Needs
EFFICIENCY – Quantity of Resources used to meet needs
COMPLIANCE – Meeting Regulatory Requirements.
The typical dictionary definition of quality refers to the „„degree or grade of excellence‟‟;
in this sense, quality is a relative measure of goodness. Defining quality as goodness is so
General that it offers no operational content. How do we build an operational definition?
The answer is, „„Adopt a customer focus.‟‟ Operationally, a quality product or service
is one that meets or exceeds customer expectations? In effect, quality is customer satisfaction.
ut what is meant by „„customer expectations‟‟? Customer expectations can be
Described by quality attributes or by what are often referred to as „„dimensions of quality.
‟Thus, a quality product or service is one that meets or exceeds customer expectations on the
following eight dimensions:
1. Performance
2. Aesthetics
3. Serviceability
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
4. Features
5. Reliability
6. Durability
7. Quality of conformance
8. Fitness for use
The first four dimensions describe important quality attributes but are difficult to measure.
Performance: refers to how consistently and how well a product functions. For services, the
inseparability principle means that the service is performed in the presence of the customer.
Thus, the performance dimension for services can be further defined by the attributes of
responsiveness, assurance, and empathy. Responsiveness is simply the willingness to help
customers and provide prompt, consistent service. Assurance refers to the knowledge and
courtesy of employees and their ability to convey trust and confidence. Empathy means
providing caring, individualized attention to customers.
Aesthetics: is concerned with the appearance of tangible products (for example, style and
beauty) as well as the appearance of the facilities, equipment, personnel, and communication
materials associated with services.
Serviceability: measures the ease of maintaining and/or repairing the product. Features
(quality of design) refer to characteristics of a product that differentiate between functionally
similar products. For example, the function of automobiles is to provide transportation. Yet,
one auto may have a four-cylinder engine, a manual transmission, vinyl seats, room to seat
four passengers comfortably, and front disk brakes; another may have a six-cylinder engine,
an automatic transmission, leather seats, room to seat six passengers comfortably, and
antilock brakes. Similarly, first class air travel and economy air travel reflect different design
qualities. First-class air travel, for example, offers more leg room and more luxurious seats.
Obviously, in both cases, the product features are different. Higher design quality is usually
reflected in higher manufacturing costs and in higher selling prices. Quality of design helps a
company determine its market. A market exists for the four-cylinder and the six-cylinder cars
as well as economy air travel and first-class air travel.
Reliability: is the probability that the product or service will perform its intended function
for a specified length of time.
Durability: is defined as the length of time a product functions.
Quality of conformance: is a measure of how a product meets its specifications. For
example, the specifications for a machined part may be a drilled hole that is three inches in
diameter, plus or minus /8 inch. Parts falling within this range are defined as conforming
parts.
Fitness of use: is the suitability of the product for carrying out its advertised functions. If
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
there is a fundamental design flaw, the product may fail in the field even if it conforms to its
specifications. Product recalls are frequently the result of fitness-of-use failures.
Improving quality, then, means improving one or more of the eight quality dimensions
while maintaining performance on the remaining dimensions. Providing a higher-quality
product than a competitor means outperforming the competitor on at least one dimension
while matching performance on the remaining dimensions. Although all eight dimensions are
important and can affect customer satisfaction, the quality attributes that are measurable tend
to receive more emphasis. Conformance, in particular, is strongly emphasized. In fact, many
quality experts believe that „„quality is conformance‟‟ is the best operational definition. There
is some logic to this position. Product specifications should explicitly consider such things as
reliability, durability, fitness for use, and performance. Implicitly, a conforming product is
reliable, durable, fit for use, and performs well. The product should be produced as the design
specifies it; specifications should be met. Conformance is the basis for defining what is meant
by a nonconforming, or defective, product.
A defective product is one that does not conform to specifications. Zero defects means
that all products conform to specifications. ut what is meant by „„conforming to
specifications‟‟? The traditional view of conformance assumes that there is an acceptable
range of values for each specification or quality characteristic. A target value is defined, and
upper and lower limits are set that describe acceptable product variation for a given quality
characteristic. Any unit that falls within the limits is deemed non defective. For example,
losing or gaining zero minutes per month may be the target value for a watch, and any watch
that keeps time correctly within a range of plus or minus two minutes per month is judged
acceptable. On the other hand, the robust quality view of conformance emphasizes fitness of
use. Robustness means hitting the target value every time. There is no range in which
variation is acceptable. A non-defective watch in the robust setting would be one that does
not gain or lose any minutes during the month. Since evidence exists that product variation
can be costly, the robust quality definition of conformance is superior to the traditional
definition.
STEP 3: Importance of Quality (10 minutes)
The following are importance of quality
agreements. product identity
the quality of a product is defined as “the degree to which a set of inherent properties of a
product, system or process fulfills requirements”, the requirements are those attributes
that reflect the identity, beauty and novelty of the product
STEP 4: Definition of Quality Control (10 minutes)
QC is defined as that part of Good Manufacturing Practice which is concerned with sampling,
specifications and testing, and with the organization, documentation and release procedures
which ensure that the necessary and relevant tests are actually carried out and that materials
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
are not released for use, nor products released for sale or supply, until their quality has been
judged to be satisfactory. The GMP requirement is:
sampling, inspecting and testing starting materials, packaging materials, intermediate,
bulk, and finished products, and where appropriate for monitoring environmental
conditions for GMP purposes
and finished products are taken by personnel and by methods approved by Quality
Control;
the required sampling, inspecting and testing procedures were actually carried out. Any
deviations are fully recorded and investigated;
quantitative composition of the marketing authorization, are of the purity required, and
are enclosed within their proper containers and correctly labeled;
bulk, and finished products is formally assessed against specification. Product assessment
includes a review and evaluation of relevant production documentation and an assessment
of deviations from specified procedures
person that it is in accordance with the requirements of the relevant authorizations;
future examination of the product if necessary and that the product is retained in its final
pack unless exceptionally large packs are produced
STEP 5: Definition of Quality Assurance (15 minutes)
collectively influence the quality of a product.
medicinal products are of the quality required for their intended use.
like product design and development.
should ensure that:
o Medicinal products are designed and developed in a way that takes account of the
requirements of Good Manufacturing Practice;
o Production and control operations are clearly specified and Good Manufacturing
Practice adopted;
o Managerial responsibilities are clearly specified;
o Arrangements are made for the manufacture, supply and use of the correct starting
and packaging materials;
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
o All necessary controls on intermediate products, and any other in process controls and
validations are carried out;
o The finished product is correctly processed and checked, according to the defined
procedures;
o Medicinal products are not sold or supplied before an authorized person has certified
that each production batch has been produced and controlled in accordance with the
o Requirements of the marketing authorization and any other regulations relevant to the
production, control and release of medicinal products;
o Satisfactory arrangements exist to ensure, as far as possible, that the medicinal
products are stored, distributed and subsequently handled so that quality is maintained
throughout their shelf life;
o There is a procedure for self-inspection and/or quality audit, which regularly appraises
the effectiveness and applicability of the quality assurance system.
o Deviations are reported, investigated and recorded;
o There is a system for approving changes that may have an impact on product quality;
o Regular evaluations of the quality of pharmaceutical products should be conducted
with the objective of verifying the consistency of the process and
o Ensuring its continuous improvement.
o pharmaceutical products are designed and developed in a way that takes account of
the requirements of GMP and other associated codes such as those of good laboratory
practice (GLP)1 and good clinical practice (GCP);
products to ensure that they are fit for their intended use, comply with the requirements of
the marketing authorization and do not place patients at risk due to inadequate safety,
quality or efficacy. The attainment of this quality objective is the responsibility of senior
management and requires the participation and commitment of staff in many different
departments and at all levels within the company, the company‟s suppliers, and the
distributors. To achieve the quality objective reliably there must be a comprehensively
designed and correctly implemented system of quality assurance incorporating GMP and
quality control. It should be fully documented and its effectiveness monitored. All parts
of the quality assurance system should be adequately staffed with competent personnel,
and should have suitable and sufficient premises, equipment, and facilities.
STEP 6: QA/QC Comparisons (20minutes)
Activity: Brainstorming (5minutes)
ASK student to brainstorm on the following question for 5 minutes
ALLOW students to brainstorm for 5 minutes
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
WRITE their responses to the flip chart/ board
CLARIFY and SUMMARIZE by using the content below
Quality Assurance and Quality Control can be compared as follows:
QUALITY ASSURANCE QUALITY CONTROL
QA is the sum total of organized QC is that part of GMP which is concerned
arrangements made with the object of with sampling, specifications, testing and
ensuring that product will be of the Quality within the organization, documentation, and
required by their intended use release procedures which ensure that the
necessary and relevant tests are carried out
All those planned or systematic actions Operational laboratory techniques and
necessary to provide adequate confidence activities used to fulfill the requirement of
that a product will satisfy the requirements Quality
for quality
QA is company based QC is lab based
STEP 7: Functions of Quality Control Laboratory in Relation to
Preparation of Pharmaceutical Products. (35 minutes)
Good Laboratory Practice (GLP) is a quality system concerned with the organizational
process and the conditions under which tests are planned, performed, monitored, recorded,
archived and reported.
and radioisotopes, which should also be separated from each other.
interference, humidity, etc.
biological or radioactive samples.
Laboratory must have the following managerial and technical personnel:
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
Quality control Laboratory is divided into the following sections.
Instrumentation
• HPLC
Wet Chemistry
The unit for preparation of reagent and volumetric solution standardization.
cabinet.
cabinet installed with exhaust system.
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
Microbiology room
divided into instrument room, media preparation room, incubation room and analysis
room.
raw materials including environmental monitoring in the critical areas.
door (self-closing)
and E. Coli monitoring including microbial limit test.
surrounding to control ingress of contaminants
Essential for shelf -life determination. The Stability chambers to be set at different
conditions
• 30C5/65%5 RH
• 30C5 & 75%5 RH
General and specific safety instructions in quality control laboratories must be
material, and occasional seminars).
include normally
blankets, and gas masks
substances
"Flammable", "Radiation", etc.) whenever appropriate
refrigerators
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
with their color identification codes
and use of antidotes
STEP 8: Key points (5 minutes)
product will be of the Quality required by their intended use
within the organization, documentation, and release procedures which ensure that the
necessary and relevant tests are carried out
STEP 9: Evaluation (5 minutes)
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
References
Gravells, A. (2016). Principles and practices of quality assurance – a guide for internal and
ex. Sage Publications.
Quality assurance of pharmaceuticals: A compendium of guidelines and related materials.
(2007). Geneva: World Health Organization.
Donabedian, A. (1990). The Process of quality assurance.
Lund, W. (2009). The pharmaceutical codex: Principles and practice of pharmaceutics. New
Delhi: CBS.
Aulton, M. E., & Taylor, K. (2018). Aulton s pharmaceutics: The design and manufacture of
medicines. Edinburgh: Elsevier.
Signore, A. A., & Jacobs, T. (2017). Good design practices for GMP pharmaceutical
facilities. Boca Raton, Fl.: CRC Press.
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
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