Prepared by Mrs. Deeksha Sharma
Chapter-1 Part(a)
PHARMACEUTICAL QUALITY ASSURANCE
B.Pharma, III Year (6th Semester)
Unit – I
QUALITY ASSURANCE AND QUALITY MANAGEMENT CONCEPTS
Introduction:
The regulatory bodies all around the world have accepted that a
pharmaceutical product which meets the following characteristics can be
accepted as a quality product Identity
 Strength
 Safety
 Purity and
 Efficacy
 What Is Quality?
 User-based: “In the eyes of the beholder”
 Manufacturing-based: “Right the first time”
 Product-based: Precise measurement
It is related to certain predetermined characteristics such as shape,
dimensions, composition, finish, colour, weight, etc.
J. M. Juran (1970) who is considered the father of quality research has
defined quality as “the performance of the product as per the commitment
made by the producer.”
According to International Organization for Standardization (ISO):
Quality is defined as “The totality of features and characteristics of a
product or service that bear on its ability to satisfy stated or implied needs.”
For example, a watch should show accurate time or a ball point pen should
write legibly on a piece of paper
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Prepared by Mrs. Deeksha Sharma
Chapter-1 Part(a)
 Quality Management (QM):
A quality management system is a management technique used to
communicate to employees what is required to produce the desired quality
of products and services and to influence employee actions to complete
tasks according to the quality specifications.
 Quality management is the act of supervising all the activities required
for maintaining a desired level of quality.
 It has four main components which are as follows:
o Quality planning: Process of translating quality policy into
processes, procedures, and instructions to achieve measurable
objectives and requirement.
o Quality assurance: Planned and methodical activities executed as
part of a quality system to provide confidence that process,
product, or service requirement for quality are being satisfied.
o Quality control: Act of monitoring, appraising, and correcting a
process, product, or service to ensure requirements for quality
being satisfied.
o Quality improvement: Process of analysing performance and
taking methodical, systemic actions to improve it.
 Business success may simply be the extent to which any organization
can produce a higher quality product or service than its competitors
are able to do at a competitive price.
 When quality is the key to a company’s success, Quality Management
system allow organizations to :
o Keep up with and meet current quality levels.
o Meet the consumer’s requirement for quality.
o Retain employees through competitive
o Compensation programs.
o Keep up with the latest technology.
Quality Management
Quality Assurance
GMP
Quality Control
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Prepared by Mrs. Deeksha Sharma
Chapter-1 Part(a)
DEFINITION AND CONCEPT OF QUALITY ASSURANCE

Definitions Of Quality Assurance:
According to WHO- “Quality assurance is a
wide ranging concept covering all matters that
individually or collectively influence the
quality of a product. The totality of the
arrangements made with the objective of
ensuring that pharmaceutical products are of
the quality required for their intended use”.
According to ISO:9000 - “Quality assurance
is a part of Quality management focussed on
providing confidence that quality requirement
will be fulfilled.”
Examples - Process checklists, Project audits & methodology and
standards development
 Concept Of Quality Assurance:
 QA is a set of activities for ensuring quality in the process by which the
products are developed.
 QA is a managerial tool.
 QA aims to prevent defects with a focus on process used to make the
product.
 Principles:
Two main principles of QA are as follows:
o Product should suitable for intended purpose i.e. Fit for purpose.
o Mistakes should be eliminate i. e. Right first time
 Objectives:
 Supervising good manufacturing practices (GMP)
 Inspecting good laboratory practices (GLP)
 Monitoring plant environment
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Prepared by Mrs. Deeksha Sharma
Chapter-1 Part(a)
 Verifying quality of raw materials
 Verifying the quality of finished product
 Ensure a safety programmed
 Responsibilities of Q.A. Department:
 QA department is responsible for ensuring that the quality policies
adopted by a company are followed to meet quality requirements.
 To identify and prepare the necessary SOP’s related to the control
quality.
 QA department ensure that the product meets all the applicable
specifications and that it was manufactured according to the standard of
GMP.
 QA also holds responsibility for quality monitoring or audit.
 QA functions to assess operations continually and to advise and guide
them towards full compliance with all applicable internal and external
regulations
 Components of Quality Assurance:
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Prepared by Mrs. Deeksha Sharma
Chapter-1 Part(a)
 Quality Assurance Methods:
Following are three methods for quality assurance
 Failure testing: Testing the product under heat, pressure or
vibration to ensure its physical strength. For software product,
failure testing might involve placing the software under high
usage or load conditions
 Statistical process control (SPC): To manage and control the
production of products this methodology uses statistical methods.
A methodology based on objective data and analysis developed by
Walter Shewhart at western Eclectic Company and Bell
Telephone Laboratories in the 1920’s and 1930’s.
 Total quality management (TQM): TQM is the integration of
all functions and processes to achieve continuous improvement of
the quality of goods and services.
There are several certifications available in the industry to ensure that
organizations follow Standard Quality Processes.
Customers make this as qualifying criteria while selecting a software
vendor.
ISO 9000
CMMI level (Capability Maturity Model Integrated)
TMM (Teat Maturity Model)
 Quality Assurance system should ensure that:
 Medicinal products are designed and developed in the way that takes
account of the requirements of Goods Manufacturing Practices.
 Production and control operations are clearly specified and Goods
Manufacturing Practices adopted.
 Managerial responsibilities are clearly specified.
 Arrangements are made for the manufacture, supply and use of the
correct starting and packaging materials.
 All necessary control on intermediate products and any other in process
control and validations are carried out.
 The finished product is correctly processed and checked, according to
the defined procedures.
 Medicinal product are not sold or supplied before an authorized person
has certified that each production batch has been produced and
controlled in accordance with the requirement of the marketing
authorization and any other regulations relevant to the production,
control and release of medicinal products.
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Prepared by Mrs. Deeksha Sharma
Chapter-1 Part(a)
To achieve the quality objective reliably there must be a comprehensively
designed and correctly implemented system of quality assurance
incorporation GMP and quality control.
It should be fully documented and its effectiveness monitored. All parts of
the quality system should be adequately staffed with competent, and
should have suitable and sufficient premise, equipment, and facilities.
DEFINITION AND CONCEPT OF QUALITY CONTROL
 Definitions Of Quality Control:
According to WHO - “ Q.C is a part of GMP
which is concerned with sampling, specification,
testing with the organization, documentation and
release procedures which ensure that the necessary
and relevant tests are actually carried out and that
materials are neither released for use, nor products
released for sale or supply, until their quality has
been found satisfactory.”
According to Alfort and Beaty - “Quality control is the mechanism by
which products are made to measure up to the specifications determined
from the customer’s demands and transform into sales, engineering and
manufacturing requirements. It is concerned with making things right
rather than discovering and rejecting those made wrong. Quality control
is a technique by means of which products of uniform acceptable quality
are manufactured.”
Examples- Inspection, deliverable peer reviews and the testing process
 Concept Of Quality Control:
 QC is a set of activities for ensuring quality in products, the activities
focus on identifying defects in actual product produced.
 QC is a corrective tool.
 QC aims to identify defects after a product is developed and before it is
released.
 Objectives:
 Reduced errors and establish quality and standard products.
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Chapter-1 Part(a)
Analyses extent of quality deviations in process.
Evaluation of methods and process of production.
Promote cost reduction.
Production of quality goods accelerates sale of goods.
Inspire more effective teamwork.
Promotion of exports due to superior and standard quality production.
 Responsibilities of QC Department:
 QC is responsible for the day-to-day control of quality within the
company.
 QC department is responsible for analytical testing of incoming raw
materials and inspection of packaging components, including labelling.
 T conduct in-process testing when required, perform environmental
monitoring and inspect operations for compliance.
 They also conduct the required tests on finished dosage forms.
 QC plays a major role in the selection of qualified vendors from whom
raw materials are purchased.
 The environmental areas for manufacturing of various dosage forms are
tested and inspected by QC department.
 Maintenance of all documents related to QC department.
 Components of Quality Control:
BATCH
INSPECTION &
SAMPLING
RECORDS
VALIDATION
QUALITY
CONTROL
COMPONENT
S
QC LABS
RETAINED
SAMPLES
ANALYSIS OF
FINISHED
PRODUCT
SAMPLING
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Prepared by Mrs. Deeksha Sharma
Chapter-1 Part(a)
 Methods or Tools of Quality Control:
Any variation in the quality of a product are mainly due to variations in raw
material, personal, methods and procedures of production and inspection. In
order to produce the quality products, these variations need to be checked and
controlled.
There are seven primary quality control tools which include:
 Pareto Chart: Visual analysis of problems can be done by this type
of bar chart so that you can target on most significant issues.
 Fishbone diagram/ Ishikawa diagram: It also cause and effect
diagram. It helps to determine to which problem associated, whether
it is material, machine, process or manpower.
 Check sheets: It helps to check crucial material required to
manufacture and sell products. Data checking by check list is first
step in analysis of quality problem.
 Control chart: The chart helps you find and correct problems as they
happen, predict a range of outcomes and analyse variations.
 Stratification: It simplifies process by separating data so that you can
identify problem area.
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Prepared by Mrs. Deeksha Sharma
Chapter-1 Part(a)
 Histogram: Its graphical method showing bars to recognize defect
and frequency of defect.
 Scatter Diagram: It visually identify relationship between variables
by plotting information along two axes on the graph. They are often
used to determine whether a stated cause truly does impact the quality
characteristics.
 Flow charts: Flow charts are often used to diagram operational
procedures to simplify the system. It shows the sequence of events in
a process.
 Quality Control system should ensure that:
 There should be Adequate facilities, trained personnel and approved
procedures are available for sampling, inspecting and testing Raw
materials, packaging materials, intermediate product, bulk, and
finished
products, and where appropriate for monitoring
environmental conditions for GMP purposes.
 Samples of starting materials, packaging materials, intermediate
product, bulk products and finished product should be taken by
personnel according to the methods approved by Quality Control.
 Test methods should be validated.
 Records should be made, manually and/ or by recording instruments,
which demonstrate that al the require sampling, inspection, and
testing procedures were actually carried out. Any deviations are fully
recorded and investigated.
 The finished product containing active ingredients should comply
with the qualitative and quantitative compositions of the marketing
authorization and should be of the purity required, and should be
enclosed within their proper containers and correctly labelled.
 All the Records containing result of inspection and that testing of
materials, intermediate bulk and finished product should be formally
assessed against specification.
 Product assessment should include a review and evaluation of
relevant production documentation and an assessment of deviations
from specified procedures.
 No batch of product should be released for sale or supply prior to
certification by authorized person that it is in accordance with the
requirements of the relevant authorizations.
 Sufficient reference samples of starting materials and products
should be retained to permit future examination of the product if
necessary and that the product is retained in its final pack unless
exceptionally large packs are produced.
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Prepared by Mrs. Deeksha Sharma
Chapter-1 Part(a)
 Difference between Quality Assurance and Quality Control:
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