QUALITY CONTROL & QUALITY ASSURANCE

A project report submitted to the Bundelkhand

University in partial fulfilment for the award of the Degree
of
Bachelor of Pharmacy

2024 – 2025

Under the guidance of: Submitted by:

Dr. Ramji Swarnkar Rahul Kumar
Prajapati
Assistant professor B.Pharm (final year)
Institute of Pharmacy Roll no:- 211251016074
Bundelkhand University
Jhansi (U.P)

INSTITUTE OF PHARMACY

BUNDELKHAND UNIVERSITY
JHANSI (U.P) INDIA

i
 Institute of Pharmacy
Bundelkhand University, Jhansi

2024 – 2025
CERTIFICATE
This is to certify that the project entitled “Quality Control & Quality
Assurance” submitted to the Institute of Pharmacy, Bundelkhand University
for partial fulfillment of the bachelor in pharmacy is the original work carried
out by Rahul Kumar Prajapati under my supervision and guidance, I wish him
good luck for his future endeavours.

HEAD OF
DEPARTMENT
Prof. Sunil Kumar Prajapati
Date:- Institute of Pharmacy
Bundelkhand University
Jhansi

ii
 Institute of Pharmacy
Bundelkhand University, Jhansi

2024 – 2025
CERTIFICATE
This is to certify that the project entitled “Quality Control & Quality
Assurance” submitted to the Institute of Pharmacy, Bundelkhand
University for partial fulfillment of the bachelor in pharmacy, is the original
work carried out by Rahul Kumar Prajapati under my supervision and
guidance, I wish him good luck for his future endeavours.

Guided by:
Dr. Ramji Swarnkar

Date Assistant professor

Institute of Pharmacy
Bundelkhand University
Jhansi (U.P)

iii
 Institute of Pharmacy
Bundelkhand University, Jhansi

2024 – 2025
CANDIDATE’S DECLARATION

I hear by declare that the project entitled submitted to the Institute of

Pharmacy, Bundelkhand University for the partial fulfillment of the
Bachelor in Pharmacy is the original work carried out by me under the
supervision and guidance of Dr. Ramji Swarnkar Assistant Professor,
Institute of Pharmacy, Bundelkhand University. To the best of my
knowledge and belief. This work has not been submitted to
any other place.

Rahul Kumar Prajapati

Date B.Pharm (final year)
Roll no:- 211251016074

iv
 Institute of Pharmacy
Bundelkhand University, Jhansi

2024 – 2025
ACKNOWLEDGMENT
The satisfaction and euphoria that accompany the successful completion of
any task would be incomplete without mentioning the people whose constant
guidance and encouragement made it possible. I take pleasure in presenting
before you, my project, which is the result of the studied blend of both
knowledge and research.
I express my earnest gratitude to my project supervisor Dr. Ramji Swarnkar.
Assistant Professor and other faculty members of our pharmacy department
for their constant support, encouragement, and guidance. I am grateful to all
of them for their cooperation and valuable suggestions.
Finally, I express my gratitude to all other members who were directly or
indirectly involved in compiling this project.

Rahul Kumar Prajapati

Date:- B.Pharm (final year)
Roll no:- 211251016074

LIST OF ABBREVATIONS

v
ABBREVIATION FULL FORM

SSSSXXAQCQC

QC Quality Control

QA Quality Assurance

SPC Statistical Process

CAPA Corrective and Preventive Actions

TQM Total Quality Management

JIT Just–In-Time

RCA Root Cause Analysis

OOS Out of specification

GMP Good manufacturing practices

FMEA Failure mode and Effects analysis

QMS Quality Management system

SOPS Standard operating procedures

ISO International Origination For Standardization

ANA American Nurses Association

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 INDEX

S.N TOPIC PAGE NO.

O
1 Certificate ii
Certificate iii
Candidate’s Declaration iv
Acknowledgment v
List Of Abbrevations vi

2 Abstract 1
3 Introduction 2
4 Quality 3-4
5 Quality Control 5-7
6 Benefits of Quality Control 7-9

7 7 Basic Tools Of Quality Control 9-11

8 Quality Control Techniques 11-13
9 Benefits And Conclusion 14

10 Quality Assurance 15-18

11 Functions of Quality Assurance 18-21
12 Approaches of Quality Improvement 22-26

13 The Eight Elements of TQM 27

14 Community Health Nursing Standard 28

15 Conclusion 29

vii
16 Reference 30-31

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PROJECT REPORT Quality Control and
Quality assurance

Abstract:- This concise overview discusses many international methods for

evaluating the concept of geotaxis. Pharmaceutical impurities, include residual
solvents and different organic and inorganic impurities. Due to national and
international requirements, it is now obligatory to provide information on a
specific pharmaceutical product's impurity profile in addition to its purity
profile. These characteristics, the importance of the quality, efficacy, and
safety of medicines, as well as the origin, types, and regulation of impurities,
are discussed. One of the requirements for the delivery of any nation's
healthcare system has been highlighted as the availability of critical medicines
of high quality, as subpar medications have the potential to hurt or even kill
their users. a chemical environment that is undesirable in a specific medicine,
Its safety and effectiveness may be affected, even in incredibly little levels. A
pharmaceutical is a dynamic product that, unlike products from other
industries, can alter between manufacture and final consumption in terms of
colour, consistency, weight, and even chemical identification. Therefore,
pharmaceutical product quality has been a worry for people all over the world,
and regulatory agencies are now paying close attention to it. Pharmaceutical
product impurities are a major source of concern due to their potential for
detrimental effects on drug stability and shelf life as well as their intrinsic
toxicity in some cases. Impurities in pharmaceutical and drug products are
undesirable substances (organic, inorganic, and residual solvents) that arise or
are added during formulation, or that remain with the active pharmaceutical
ingredients (APIs) during storage. Even with sufficient precaution, organic I
purities are the most prevalent contaminants discovered in every API and are
not included during the multi-step manufacturing process.
To deliver high-quality goods and services that fully satisfy the needs and
expectations of their clients, clinical trial sponsors and contract research
organization must establish, maintain, and closely monitor their QC and QA
systems, as well as their integral standard operating procedures and other
quality documents. The primary quality systems incorporate both quality
assurance and control systems. Control and quality assurance are essential
parts of quality management. Quality assurance ensures that the standards are
met, whereas quality control ensures that they are met. The organization's
business goals and model need to be in line with the quality systems
Keywords: : quality management, quality assurance, quality control, good
manufacturing practice

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INTRODUCTION
The term quality assurance (QA), which is used in both the services and
manufacturing sectors, refers to the systematic steps taken to ensure that the
product delivered to the customer needs to satisfy their collective expectations
as well as other established performance, design, reliability, and
maintainability assumptions. The main goal of quality assurance is to infection
prevention and control and flaws in the design, development, and
manufacturing of both primary commodities like cars and shoes, as well as
given services like athletic shoe and car design. The “component of quality
management focused on creating assurance that quality criteria will be
satisfied” is what ISO 9000 identifies as ensuring quality and, as a result,
preventing issues and delays while delivering products or services to
customers. This element of fault prevention quality assurance differs from the
unsure detection aspect of quality control and has been referred to as a shift
left since it focuses on quality efforts earlier in product development and
production (i.e., a shift to the left of a linear process diagram reading left to
right) and on avoiding defects in the first place rather than correcting them
after the fact. The terms “quality assurance” and “quality control” are often
used interchangeably to refer to ways of ensuring the quality of a service or
product. For instance, the term “assurance” is often used in a context such as:
Implementation of inspection and structured testing as a measure of quality
assurance in a television set software project at Philips Semiconductors is
described. where “inspection and structured testing” are the measurement
phase of a quality assurance strategy referred to as the DMAIC model (define,
measure, analyse, improve, control). DMAIC is a data driven quality strategy
used to improve processes. The term “control” is the fifth phase of this
strategy.
In the past, it has been more challenging to define what a suitable product or
service’s quality is. This has been done in a variety of ways, from the subjective
user-based approach, which includes “the different weights that individuals
typically attach to quality characteristics,” to the value-based approach, which
finds that consumers link quality and price and draw general conclusions about
quality based on these associations.

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QUALITY

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Quality
"Quality is defined as the degree to which health services for the individuals
and populations increase the likelihood of the desired health outcomes and
are consistent with current professional knowledge".
-Joint Commission on Accreditation of Healthcare Organizations (2002)
"Quality of a service is defined as the totality of features and characteristics of
a service that bear on its ability to satisfy the stated and implied needs of the
patients". -International Organization for Standardization (ISO 8402)
All the batches of the product should be analyzed and approved According to
the requirements of the relevant authorizations.
It should be ensured that the finished product contains APIs that Comply with
the qualitative & quantitative composition of the marketing authorization are
of the required purity & are enclosed in properly labeled containers [.
Sample of starting material packaging material intermediates & Bulk finished
product should be taken by personal & by method Approved by quality control
department.

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Quality
Control

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Meaning Of Quality Control

 Quality control (QC) is a process through which a business seeks to
ensure that product quality is maintained or improved.
 Quality control involves testing units and determining if they are within
the specifications for the final product.
 The quality control used in a business is highly dependent on the
product or industry, and several techniques exist for measuring quality.
 The food industry uses quality control methods to ensure customers do
not get sick from their products.
 Quality control creates safe measures that can be implemented to make
sure deficient or damaged products do not end up with customers.
 Quality control is mainly about "detecting" defective output-rather than
preventing it. Quality control can also be a very expensive process.
Emcee G, in recent years, business have focused on quality management
and quality assurance.

Definition Of Quality Control

Quality control (QC) is a process used to ensure that a product or service meets
specific quality standards and requirements. It involves the systematic
monitoring and evaluation of various aspects of production, including
materials, processes, and final outputs. The main goals of quality control are to
identify defects, reduce variability, and ensure customer satisfaction by
maintaining consistent quality. QC techniques may include inspections, testing,
and statistical analysis.

Basic Examples Of Quality Control

1. Product Inspections: Checking finished products for defects or
deviations from specifications before they are shipped to customers.
2. Sampling: Taking a random sample of products from a production
batch to test for quality attributes, such as size, weight, or functionality.

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3. Process Control: Monitoring production processes using control

charts to ensure they remain within specified limits, helping to identify
trends or variations that could lead to defects.
4. Standard Operating Procedures (SOPs): Establishing and following
documented procedures for tasks to ensure consistency and quality in
production.
5. Calibration: Regularly calibrating measurement tools and equipment
to ensure they provide accurate results.
6. Internal Audits: Conducting audits of processes and systems to ensure
compliance with quality standards and identify areas for improvement.
7. Customer Feedback: Collecting and analysing feedback from
customers to identify areas for improvement and ensure products meet
user expectations.

When Does Quality Control Occur?

1. Pre-Production: QC can start during the planning phase by reviewing
materials, supplier quality, and setting quality standards.
2. In-Process Control: During production, ongoing checks are made to
monitor processes and ensure that they conform to quality specifications.
This includes regular inspections and measurements.
3. Final Inspection: After production, finished products are evaluated to
check for defects or quality issues before they are packaged and shipped .
4. Post-Production: QC continues after the product reaches the customer,
where feedback is gathered and analysed to address any issues and
improve future quality.

Benefits of Quality Control

 Improved Product Quality: Ensures that products meet specifications
and customer expectations, reducing defects and enhancing overall
quality.
 Increased Customer Satisfaction: Consistently high-quality products lead
to greater customer trust and loyalty, resulting in repeat business and
positive referrals.
 Cost Reduction: Identifying defects early in the process reduces waste,
rework, and returns, ultimately lowering production costs.

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 Enhanced Efficiency: Streamlining processes and establishing standards

can lead to more efficient operations and reduced downtime.
 Risk Mitigation: Regular monitoring and testing help identify potential
issues before they escalate, minimizing risks associated with poor quality.
 Regulatory Compliance: Many industries have strict quality standards.
QC helps ensure compliance with regulations, avoiding legal issues and
penalties.
 Continuous Improvement: Establishing a culture of quality encourages
ongoing assessment and refinement of processes, driving innovation and
long-term success.
 Employee Engagement: Involving employees in quality initiatives fosters
a sense of ownership and accountability, leading to improved morale and
productivity.

Objectives of Quality Control

 Ensuring Product Quality: To consistently produce products that meet
established quality standards and customer expectations.
 Reducing Defects: To identify and eliminate defects in products and
processes, minimizing waste and rework.
 Enhancing Customer Satisfaction: exceed customer needs and
preferences: To deliver reliable and high-quality products that meet or.
 Maintaining Consistency: To ensure uniformity in production
processes and outputs, leading to predictable and reliable results.
 Training and Development: To educate employees about ks. quality
standards and practices, fostering a culture of quality throughout the
organization.
 Minimizing Costs: Effective quality control can help identify defects
early in the production process, which reduces the costs associated with
rework, waste, or customer returns. It also ensures that resources are
used efficiently.
 Compliance with Standards and Regulations: Companies must
comply with industry regulations, certifications, and standards (such as
ISO, ASTM, etc.). Quality control helps in meeting these standards and
avoiding legal or regulatory issues.
 Continuous Improvement: Quality control is not just about checking
quality but also improving the processes. By using tools like Six Sigma,
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Total Quality Management (TQM), or Statistical Process Control (SPC),

businesses can continuously refine their production processes.
 Risk Mitigation: Identifying potential risks or defects during production
minimizes the chances of product recalls, damage to brand image, and
harm to consumers, which are costly and damaging for businesses.

7 Basic tools of Quality Control

1) Check sheet
2) Control chart/ Run
3) Histogram
4) Fishbone Diagrams (Ishikawa Diagrams)
5) Pareto chart
6) Scatter diagram
7) Flow chart

Fig of Basic tools of Quality Control

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Check Sheets: Simple forms used to collect and analyse data systematically.
They help track defects, frequencies, or issues over time.

Control Charts / Run: Statistical tools used to monitor processes over time,
indicating whether a process is in control or if variations are due to specific
causes.

Histograms: Graphical representations of data distribution that help identify

patterns, variations, and trends within a dataset.

Fishbone Diagrams (Ishikawa Diagrams): Visual tools that identify

potential causes of a problem, helping teams brainstorm and categorize root
causes.

Pareto Charts: Bar graphs that display the most significant factors in a
dataset, following the 80/20 rule (80% of problems often come from 20% of
causes).

Scatter Diagrams: Graphs that show the relationship between two variables,
helping to identify correlations and potential causes of issues.

Flowcharts: Diagrams that map out a process step-by-step, making it easier

to understand workflows and identify areas for improvement.

Quality Control Through Production Systems

Quality control in production systems involves integrating QC practices
throughout the manufacturing process to ensure consistent product quality.
Here are key aspects of implementing quality control in production systems:

 Design Quality: Establishing quality standards during the product

design phase helps ensure that the final product meets customer
expectations and specifications.
 Process Standardization: Developing and documenting standard
operating procedures (SOPs) for production processes helps maintain
consistency and reduces variability.
 Employee Training: Providing training for employees on quality
standards, techniques, and tools empowers them to recognize and
address quality issues.
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 Real-Time Monitoring: Utilizing technology, such as sensors and data

analytics, to monitor production processes in real time allows for
immediate identification of deviations from quality standards.
 Statistical Process Control (SPC): Implementing SPC techniques
helps analyse process data to detect trends and variations, enabling
proactive adjustments to maintain quality.
 Quality Inspections: Conducting regular inspections and testing at
various stages of production helps identify defects early, reducing the
likelihood of defective products reaching customers.
 Feedback Loops: Establishing mechanisms for collecting feedback
from customers and employees helps identify areas for improvement
and fosters a culture of continuous quality improvement.
 Corrective and Preventive Actions (CAPA ): Implementing CAPA
processes ensures that issues are not only addressed but also prevented
from recurring in the future.

Quality Control Techniques

 Statistical Process Control (SPC)
 Inspection
 Sampling
 Total Quality Management (TQM)
 Failure Mode and Effects Analysis (FMEA)
 Root Cause Analysis (RCA)
 Quality Audits
 Pareto Analysis
 Benchmarking
 Just-In-Time (JIT)

Statistical Process Control (SPC): Uses statistical methods to monitor and

control processes. Control charts help identify variations and maintain process
stability.

Inspection: Involves examining products or processes at various stages to

ensure they meet quality standards. This can include visual checks,
measurements, and tests.

Sampling: Instead of inspecting every item, sampling techniques allow for

evaluating a subset of products, which can be more efficient and cost-effective.

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A data-driven approach that seeks to reduce defects and improve process

quality by identifying and eliminating causes of variability.

Total Quality Management (TQM): A comprehensive management

approach focused on continuous improvement, customer satisfaction, and
involving all employees in quality initiatives.

Failure Mode and Effects Analysis (FMEA): A proactive technique that

identifies potential failure modes in a process or product and evaluates their
impact, helping prioritize improvements.

Root Cause Analysis (RCA): A systematic approach to identifying the

underlying causes of defects or problems to implement effective solutions.

Quality Audits: Regular assessments of processes and systems to ensure

compliance with quality standards and identify areas for improvement.

Pareto Analysis: A technique that uses the 80/20 rule to prioritize issues by
identifying the most significant factors contributing to problems.

Benchmarking: Comparing processes and performance metrics against

industry best practices or competitors to identify areas for improvement.

Just-In-Time (JIT): Just-In-Time (JIT) in quality control refers to integrating

JIT principles into the quality management process to enhance efficiency and
reduce waste while ensuring product quality. Here’s how JIT applies to quality
control:

1. On-Demand Production: JIT emphasizes producing only what is needed

when it is needed. This minimizes excess inventory and reduces the
chances of defects in unsold goods.
2. Quality at Every Stage: JIT promotes the idea of building quality into
every step of the production process. Instead of inspecting for quality at
the end, quality checks occur throughout, reducing the likelihood of
defects.
3. Supplier Quality Management: Strong relationships with suppliers
ensure that materials arrive just in time and meet quality standards,
minimizing delays and defects caused by poor materials.
4. Rapid Response to Issues: JIT encourages quick identification and
resolution of quality issues, allowing teams to address problems
immediately rather than after a large batch has been produced.
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5. Employee Involvement: JIT fosters a culture where employees are

empowered to identify and address quality issues, contributing to
continuous improvement.
6. Data-Driven Decisions: JIT relies on real-time data to monitor production
processes, allowing for immediate adjustments to maintain quality
standards.

ISO 9000
The ISO 9000 family of standards is related to quality management
systems and designed to help organizations ensure that they meet the
needs of customers and other stakeholders while meeting statutory and
regulatory requirements.

ISO 9000 deals with the fundamentals of quality management systems,

including the eight management principles on which the family of
standards is based. International standards promote international trade
by providing one consistent set of requirements recognized around the
world. ISO 9000 can help a company satisfy its customers, meet
regulatory requirements and achieve continual improvement. It provides
the base level of a quality system, not a complete guarantee of quality.
Originally published in 1987 by the International Organization for
Standardization (ISO), a specialized international agency for
standardization composed of the national standards bodies
of 90 countries.

ISO
Objectives: To promote the development of standardizations and related
activities in the world with a view to facilitating international exchange of
goods and services, and to developing cooperation in the spheres of
intellectual, scientific, technological and economic activity.

Principle
 Demonstrate ability to consistently provide product to meet customer and
applicable regulatory requirements

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 Enhance customer satisfaction

 Improve the quality of its own operations
 Provide confidence to internal management and interested parties that the
requirements of a quality management system are being
effectively implemented.

Benefits
 ISO 9000 certification has become the de facto minimum requirement for
entering inti global markets
 It provides an opportunity to increase value to the activities of te
organization, by streamlining quality management system.
 Improves the performance of processes/activities continually thereby
reducing the cost of production
 It gives importance to customer satisfaction
 It helps to improve customer relations by providing quality product or
service
 It also acts an incentive to develop employee relations, employee
empowerment and organizational development.

Conclusion
 Quality Control (QC) is a procedure or set of procedures intended to
ensure that a manufactured product or performed service adheres to a
defined set of quality criteria or meets the requirements of the client or
customer.
 Quality Control is a product-oriented process.
 Quality Control makes sure the end product meets the quality
requirements
 Quality control can be noted as a reactive process.
 QC ensures that products are consistently manufactured or delivered to
the required standards, which helps maintain customer satisfaction and
brand reputation.
 Quality control is not a one-time task but a continuous process. It
contributes to ongoing improvements in the manufacturing or service
process, promoting innovation and long-term business success.

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 QC helps organizations meet regulatory standards and avoid legal and

safety issues that may arise from substandard products.
 Quality control is not a one-time task but a continuous process. It
contributes to ongoing improvements in the manufacturing or service
process, promoting innovation and long-term business success.

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Quality ASSURANCE

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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. With
regard to pharmaceuticals, quality assurance can be divided into major areas:
development, quality control, production, distribution, an inspection. ISO 9000
defines as "part of quality management focused on providing confidence that
quality requirements will be fulfilled"

 Quality assurance (QA) is a systematic process that ensures a product or

service meets the required quality standards.
 QA is a proactive process that helps identify and address quality
problems before they occur. It's different from quality control (QC),
which is a narrower process that focuses on detecting mistakes after
they've occurred.
 It is a systematic process to ensure the quality and safety of medical
care:
 QA aims to prevent defects with a focus on the process used to make
the product. It is a proactive quality process. The goal of QA is to
improve development and test processes so that defects do not arise
when the product is being developed.

Key Terms Related To Quality

Assurance
 Quality Control (QC)
 Good Manufacturing Practices (GMP)
 Standard Operating Procedures (SOPs)
 Quality Management System (QMS)
 Compliance
 Audits Risk Management
 Batch Record:
 Out-of-Specification (OOS)
 Continuous Improvement
 Training and Competency

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Objective of quality assurance

Quality assurance (QA) aims to ensure that products and services meet specific
standards and requirements. Here are the key objectives of quality assurance:

1. Consistency: Ensure that products and services are consistently

produced to meet quality standards.
2. Customer Satisfaction: Enhance customer satisfaction by delivering
products that meet or exceed expectations.
3. Defect Prevention: Identify and eliminate potential defects early in
the development process to reduce costs and improve efficiency.
4. Compliance: Ensure adherence to industry standards, regulations, and
internal policies.
5. Continuous Improvement: Foster a culture of continuous
improvement through regular feedback and analysis of processes and
outcomes.
6. Risk Management: Identify, assess, and mitigate risks related to
product quality and operational processes.
7. Cost Reduction: Reduce costs associated with rework, returns, and
warranty claims by improving overall quality.
8. Training and Development: Equip employees with the necessary
skills and knowledge to maintain quality standards.
9. Documentation: Maintain thorough documentation of quality
processes, standards, and results for accountability and traceability.
10.Stakeholder Confidence: Build trust and confidence among
stakeholders (customers, employees, and partners) in the organization’s
commitment to quality.

Principle of quality assurance

The principles of quality assurance (QA) provide a framework for ensuring
quality in processes, products, and services. Here are some key principles:

1. Customer Focus: Understand and meet customer needs and

expectations. Satisfied customers are essential for long-term success.
2. Leadership: Strong leadership creates a culture of quality and drives
commitment to quality assurance throughout the organization.
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3. Engagement of People: Involve all employees in the quality process.

Empowerment and participation contribute to a culture of quality.
4. Process Approach: Manage activities and resources as processes to
achieve consistent and predictable results. This helps identify
inefficiencies and areas for improvement.
5. Improvement: Foster a culture of continual improvement. Regularly
assess processes and practices to enhance performance.
6. Evidence-Based Decision Making: Base decisions on data and
analysis. Use objective evidence to evaluate processes and outcomes.
7. Relationship Management: Establish and maintain beneficial
relationships with stakeholders, including suppliers and customers, to
enhance quality and performance.
8. Systematic Approach: Recognize that quality management is a
systematic process that involves integrating all aspects of quality within
the organization.

Functions Of Quality Assurance

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Quality assurance (QA) involves several key functions to ensure that products
and services meet quality standards and fulfil customer expectations. Here are
the primary functions of quality assurance:

Prevention of quality problems through planned and systematic activities

including documentation. Establish a good quality management system and
the assessment of its adequacy. Periodic conformance audits of the
operations of the system.

1. Quality Planning: Define quality standards, objectives, and processes

required to achieve desired quality levels. This includes developing
quality management plans and protocols.
2. Quality Control: Monitor and evaluate processes and outputs to ensure
they meet the defined quality standards. This often involves inspections,
testing, and audits.
3. Process Improvement: Identify areas for improvement in processes and
systems. Implement strategies to enhance efficiency and reduce defects.
4. Documentation and Record Keeping: Maintain accurate records of
quality processes, procedures, and outcomes. Documentation is
essential for compliance and traceability.
5. Training and Development: Provide training for employees on quality
standards, processes, and tools. This helps build a quality-focused
culture within the organization.
6. Auditing and Review: Conduct regular internal and external audits to
assess compliance with quality standards and identify areas for
improvement.
7. Customer Feedback Management: Collect and analyze customer
feedback to gauge satisfaction and identify areas for enhancement.
8. Supplier Quality Management: Evaluate and monitor suppliers to
ensure they meet quality requirements. This includes conducting
supplier audits and assessments.
9. Risk Management: Identify potential risks to product and service quality
and develop strategies to mitigate those risks.
10.Reporting and Analysis: Analyse quality data and report findings to
stakeholders. This helps in informed decision-making and strategy
development.

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Components of quality assurance

 Structure of Evaluation
 Process Evaluation
 Outcome Evaluation

Quality Assurance Procedures

Good practice for QA procedures requires an objective review to assess the quality of the
inventory, and also to identify areas where improvements could be made. The inventory
may be reviewed as a whole or in parts. QA procedures are utilised in addition to the Tier 1
and Tier 2 QC. The objective in QA implementation is to involve reviewers that can conduct
an unbiased review of the inventory. It is good practice to use QA reviewers that have not
been involved in preparing the inventory. Preferably these reviewers would be independent
experts from other agencies or a national or international expert or group not closely
connected with national inventory compilation. Where third party reviewers outside the
inventory agency are not available, staff from another part of the inventory agency not
involved in the portion of the inventory being reviewed can also fulfil QA roles.

 Establishment of standards or criteria

 Identify the information relevant to criteria
 Determine ways to collect information
 Collect and analyse the information
 Compare collected information with established criteria
 Make a judgment about quality
 Provide information and if necessary, take corrective action regarding
findings of appropriate sources

Models of quality assurance

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ANA Quality Assurance Model

Plan, Do, Study, Act Cycle

Levels of evaluation of quality of care

 National level
 Trust or Organization level
 Local level
Approaches of Quality Improvement
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General Approaches

 Credentialing
 Licensure
 Accreditation
 Certification
 Charter
 Academic Degrees

Specific Approaches

 Peer Review Committees (Staff Review Committees)

 Standard as a device for quality assurance

Factors Affecting Quality Assurance in Nursing Practice

 Lack of resources
 Personnel problem
 Improper maintenance
 Unreasonable patients and attendants
 Absence of well-informed population
 Absence of accreditation laws
 Lack of incident review procedure
 Lack of good hospital information system
 Absence of patient satisfaction surveys
 Lack of nursing care research
 Miscellaneous factors

Barriers of Quality Improvement Efforts

 The nurse manager might become pre occupied with quality assessment
 It is impossible to identify all factors that influence nursing care quality
 Difficulty in defining outcome criteria that result solely from nursing
intervention
 Nurse's documentation of care measures is at times vague, incomplete
and lacking in objectivity
 There is still no single, all purpose, all site quality assessment tool that is
universally appropriate for all health agencies.
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 High cost

Role of Nurses in Quality Assurance

 Nurses are the active participant in interdisciplinary quality
improvement team
 Develop a mechanism for continually monitoring the effectiveness of
nursing care both a collaborative and an individual professional activity.
 Contribute to innovation and improvement of patient care
 Participating in improvement projects and patient safety initiatives
 Participate in continuing educational programs and in-service
educational programs for continuing professional development
 Periodic and continuing appraisal and evaluation of the health care
situation of the patient
 Participate in research works related to quality assurance

 Identify any area of needed improvement in the delivery of care

Advantages of nursing audit

 Improved Patient Care Quality: Nursing audits help identify areas

where patient care can be improved, ensuring that nurses adhere to
clinical guidelines and best practices. This contributes to better health
outcomes, enhanced patient safety, and overall quality of care.
 Ensures Compliance with Standards: Audits assess whether
nursing practices align with established clinical guidelines, protocols,
and regulatory requirements (such as those from healthcare
accreditation bodies). This helps maintain compliance with local and
international standards and avoids legal issues.
 Enhances Accountability and Transparency : Regular nursing
audits hold nursing staff accountable for their actions, ensuring they
follow standard operating procedures. Audits create a transparent
environment where issues can be identified and rectified promptly.

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 Identifies Gaps in Training and Education: Through audits,

discrepancies between actual practices and expected standards can be
identified, revealing areas where additional training or professional
development is needed. This helps ensure that nurses have the
necessary skills to provide high-quality care.
 Promotes Continuous Improvement: Nursing audits are part of a
continuous quality improvement cycle. They allow for the identification
of weaknesses and opportunities for improvement in nursing practices.
Insights gained from audits help develop strategies for improving
patient care processes and nursing performance over time.
 Reduces Medical Errors and Risks: By identifying systemic issues,
nursing audits can help reduce medical errors, adverse events, and
patient safety risks. This can involve ensuring proper documentation,
timely medication administration, and adherence to infection control
measures.
 Improved Resource Utilization: Nursing audits help in evaluating
the use of hospital resources, ensuring that nursing staff are using
supplies and equipment efficiently. This can lead to cost savings and
better resource management within healthcare facilities.
 Enhanced Patient Satisfaction: When nursing audits lead to
improvements in patient care processes, the result is often higher levels
of patient satisfaction. Audits ensure that patients receive the best care
possible, which in turn enhances their experience and trust in the
healthcare system.
 Facilitates Data-Driven Decisions: Nursing audits provide valuable
data that helps healthcare administrators make informed decisions.
Data from audits can be used to analyze trends, forecast future needs,
and guide evidence-based practices to improve patient outcomes.
 Supports Accreditation and Certification: Audits play a crucial
role in ensuring that healthcare facilities meet the requirements of
accreditation bodies. Regular nursing audits are often part of the
certification process and demonstrate the facility’s commitment to high
standards of patient care.

Disadvantages of nursing audit

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Nursing audits are an essential component of quality assurance, but they come
with several disadvantages that can affect their effectiveness and the overall
nursing practice. Here are some key disadvantages specific to nursing audit
quality assurance:

1. Resource Demands
 Time Consumption: Conducting thorough audits requires substantial
time and effort from nursing staff, which can detract from direct patient
care.
 Financial Costs: Audits may require financial investment in training,
tools, and personnel, straining budgetary resources.

2. Staff Resistance
 Defensiveness: Nurses may feel defensive or apprehensive about being
audited, which can lead to reluctance to participate fully.
 Fear of Repercussions: Concerns about negative consequences, such as
disciplinary actions, may inhibit open communication and honest
reporting.

3. Subjectivity and Bias

 Inconsistent Findings: Variability in auditors’ interpretations and biases
can lead to inconsistent audit results and evaluations.
 Personal Bias: Auditors' personal beliefs or experiences may influence
their assessments, potentially skewing results.

4. Inadequate Training
 Skill Gaps: If auditors lack adequate training or understanding of nursing
practices, audits may yield inaccurate or irrelevant findings.
 Limited Knowledge of Context: Auditors unfamiliar with the specific
healthcare environment may overlook critical factors affecting care
quality.

5. Narrow Focus
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 Limited Scope: Audits may concentrate on specific areas of care,

potentially missing broader systemic issues that affect quality.
 Snapshot Assessments: Audits often provide only a temporary view of
performance rather than ongoing monitoring of quality over time.

6. Impact on Quality Improvement

 Check-Box Mentality: There may be a tendency to focus on meeting

audit criteria rather than genuinely striving for quality improvement,
leading to superficial compliance.
 Neglecting Continuous Improvement: The emphasis on compliance can
overshadow efforts to foster a culture of continuous quality
improvement.

7. Morale and Job Satisfaction

 Increased Stress: The audit process can create a high-pressure

environment, affecting nurse morale and job satisfaction.
 Team Dynamics: The focus on individual performance may create
competition rather than fostering collaboration among staff.

8. Follow-Up Difficulties

 Implementation Challenges: Translating audit findings into actionable

improvements can be complex and may require additional resources and
commitment.
 Sustainability Issues: Maintaining improvements identified in audits
requires ongoing efforts, which can be challenging to sustain over time.

9. Focus on Compliance Rather Than Innovation:

 Nursing audits often prioritize compliance with existing standards and
protocols, which can limit innovation in care practices. This emphasis on
adherence to guidelines might discourage nurses from exploring new
methods or improving care practices.
 Audits typically focus on specific aspects of care or process, which means
they might not capture the full complexity of patient care. A narrow
focus can overlook systemic issues that impact the overall quality of
nursing services.

The Eight Elements of TQM

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Ethics: - The discipline concerned with good and bad in any situation. It is a
two-faceted subject represented by organizational and individual ethics.
Further, organizational ethics establish a business code of ethics that outlines
guidelines that all employees are to adhere to in the performance of their
work.

Integrity: - This implies honesty, morals, values, fairness, adherence to the

facts, and sincerity. Integrity characteristic is what customers (internal or
external) expect and deserve to receive. People see the opposite of integrity as
duplicity.

Trust: - Trust is a by-product of integrity and ethical conduct. Without trust,

the framework of TQM cannot be built. Trust fosters the full participation of all
members. Subsequently, it allows empowerment that encourages pride
ownership and it encourages commitment.

Training:- Training is very important for employees to be highly productive.

Supervisors are solely responsible for implementing and teaching their
employees the philosophies of TQM. Training that employees require is
interpersonal skills, the ability to function within teams, problem-solving,
decision-making, job management performance analysis and improvement,
business economics, and technical skills.

Teamwork: - Teams provides more permanent improvement in processes &

operations.

Leadership: It is possibly the most important element in TQM. It appears

everywhere in an organization. Leadership in TQM requires the manager to
provide an inspiring vision, make strategic directions that are understood by
all, and instill values that guide subordinates. TQM has to be introduced and
led by top management. Commitment and personal involvement are required
from top management in creating and deploying clear quality values and goals.

Communication: - It acts as a vital link between all elements of the TQM. It

can be upward communication, downward communication, or sideways
communication

Recognition:-It should be provide for both suggestions and achievements for

teams as well as individuals

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Community Health Nursing Standards

Community health nursing standards in quality assurance focus on ensuring
that nursing care delivered in community settings is safe, effective, and
patient-centred. Here are some key aspects:

 Evidence-Based Practice: Nursing practices should be based on the

latest research and best practices to ensure effective interventions.
 Patient Safety: Implementing protocols to minimize risks and ensure the
safety of patients in community settings.
 Performance Evaluation: Regular assessments of nursing staff
performance to ensure compliance with established standards.
 Continuous Education: Ongoing training and education for nurses to
keep up with advancements in community health.
 Patient-Cantered Care: Ensuring that care plans are developed with the
involvement of patients and tailored to their specific needs.
 Data Collection and Analysis: Utilizing data to monitor outcomes,
identify areas for improvement, and inform decision-making.
 Collaboration and Communication: Encouraging teamwork among
healthcare providers to enhance service delivery.
 Ethical Standards: Adhering to ethical guidelines in all aspects of
community health nursing.
 Regulatory Compliance: Following local, state, and national regulations
governing nursing practices.
 Community Engagement: Actively involving the community in health
promotion and disease prevention initiatives.
 Facilitating access and equity: Integrates application of the principles of
primary health care in working with others to facilitate universal and
equitable access to service and addressing determinants of health.
 Demonstrating professional responsibility and accountability:
acknowledges the autonomy of community health nursing practice and
the practitioner's responsibility in providing competent care within a
complex environment.
 Competence and Professional Development: Continuous professional
development is critical to maintaining competence. Nurses should
engage in ongoing education, attend workshops, and stay informed
about new health trends and interventions. Performance appraisals and
skill assessments are also part of QA to ensure nurses are qualified and
competent

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Conclusion
Quality Assurance (QA) in pharmaceutical science is a crucial aspect of ensuring
that pharmaceutical products are safe, effective, and consistently meet
regulatory and quality standards. In the highly regulated pharmaceutical
industry, QA encompasses a wide range of activities, including the design,
implementation, and monitoring of systems that control the manufacturing
processes, raw materials, packaging, labelling, and distribution of drugs.
Through a combination of rigorous testing, validation, documentation, and
compliance with Good Manufacturing Practices (GMP), QA ensures that each
pharmaceutical product meets the required specifications and regulatory
requirements.

QA in pharmaceutical science not only protects patient health and safety but
also improves the overall efficiency and reliability of the production processes.
It aids in minimizing the risks of contamination, errors, or inconsistencies in
drug production, ensuring that only high-quality medicines reach the market.
Moreover, a strong QA system promotes continuous improvement through
audits, corrective actions, and root cause analysis of potential deviations,
contributing to the evolution of industry standards.

The success of pharmaceutical products in terms of therapeutic effectiveness

and patient safety is directly linked to the thorough implementation of QA
systems. As such, maintaining a robust QA framework is not only a regulatory
requirement but also a key factor in the success and reputation of
pharmaceutical companies in the global market.

The drug was first invented for morning sickness problem in the pregnant
women’s. Due to lack of proper analysis and quality check it has cause a black
history, thus this also clearly proves that the quality assurance has a very
important role in production of medication. Quality assurance is not only
implemented or emphasize in pharmaceutical industry whereas it is emphasize
on every production industry which is related to every feel. As it was said that
QA works based on customers satisfaction, customer is the main source which
gives profit and revenue to any industry. If the product does not have qualities
then it will a big failure to the industry.¹⁸ QA has its role in every part of a
industry which is inter-related, QA can form many branches of department
“under their Umbrella” to increase the efficacy and the standard of the quality
by ever means and methods.

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Quality assurance

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