T RESHMA, ASSISTANT PROFESSOR, DEPT.

OF PQA - RIPER

QUALITY ASSURANCE AND QUALITY MANAGEMENT CONCEPTS

Quality:
Quality is defined as a degree to which a set of inherent characteristics or properties of a product
or services fulfils the customer requirements.
Quality Management System (QMS):
A Quality Management System (QMS) is a set of policies, procedures, and processes that an
organization implements to achieve and maintain a high level of quality in its products,
services.
The QMS focuses on meeting customer expectations and requirements, enhancing efficiency
and effectiveness, reducing risks and errors, and continuously improving performance.
The QMS also perform the inspection of product or services is performed to ensure the products
have met the specified requirements.
Components of QMS:
1. Quality Planning
2. Quality Control
3. Quality Assurance
4. Quality Improvement
1. Quality Planning:
To obtain quality, identify the requirements, set the criteria and plan a well-established
procedure.
2. Quality Control:
It is defined as a set of activities intended to ensure the quality in the product.
3. Quality Assurance (QA):
It is defined as a set of activities intended to assure the quality in the process and product.
In QA, there are several stages involved,
• Understand the customer needs
• Define the objectives
• Design the product
• Prototyping (Preliminary design of product)
• Quality testing
• Customer approval
• Pilot test
• Quality test
• Customer feedback
• Large scale manufacturing
• Follow-up customer feedback

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4. Quality Improvement:
It refers, anything that enhance the product or services to meet the quality requirements and it
is a cyclic method for the continuous improvement of the process as follows,
• Plan
• Do
• Check
• Act
CONCEPT OF QUALITY CONTROL (QC)
Definition:
Quality control is defined as a process or set of activities which are intended to ensure the
quality in the or of the product.
Objectives of Quality Control:
• To establish the desired quality standards which are acceptable by the customer.
• To identify the flaws and variations in the raw materials and manufacturing process.
• To improve the quality of the product.
• To study and identify the extent of deviations in a product during the manufacturing
and analyze the deviations.
Responsibilities of Quality Control:
• It is responsible for Day-to-Day control of quality within the company.
• It is responsible for analytical testing of incoming raw materials and packaging
components.
• I t is responsible for selection of vendors.
• It is responsible for the inspection of plant environment.
CONCEPT OF QUALITY ASSURANCE (QA)
Definition:
Quality Assurance is defined as a process or set of activities which are intended to assure the
quality in the process of manufacturing and as well as product.
Objectives of Quality Assurance:
• It enhances the efficiency of the product.
• It assures the quality of raw materials and finished product.
• Evaluating the Plant environment.
• It manages the Good Laboratory Practices (GLP) and Good Manufacturing Practices
(GMP).
Responsibilities of Quality Assurance:
• Ensuring the proper manufacturing process.
• Maintain batch records and review.
• Make Master plan for the entire process.

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• To perform the self-inspection.

• To investigate, record and report the deviations and the analyze the cause of deviations.
Difference between Quality Control and Quality Assurance
S. No Quality Control Quality Assurance
1 Quality control is defined as a process Quality Assurance is defined as a
or set of activities which are intended process or set of activities which are
to ensure the quality in the or of the intended to assure the quality in the
product process of manufacturing and as well as
product
2 It is also called as Wet Laboratory It is also called as Dry Laboratory
3 It focuses on the product’s quality It focuses on the quality of process
4 Its goal is to make the quality product Its goal is to make the quality process
without any defects without any defects
5 Quality Control department is Everyone is responsible
responsible
6 It is a corrective tool It is a Preventive tool
GOOD MANUFACTURING PRACTICES (GMP)
Good Manufacturing Practices (GMP) is a set of Rules and Regulations (Provisions), Codes
and Guidelines for the manufacture of drug product and drug substances, Medical devices, In-
vivo and In-vitro diagnostic tools and Food.
Objectives of GMP:
• To provide the high-quality products to the consumer.
• To ensure the provided products are free of all possible contamination.
Principles or Guidelines of GMP
Principles or Guidelines of GMP related to Buildings and Facilities:
• Design and Construct features
• Lighting
• Ventilation
• Plumbing
• Waste Management
• Washroom and Toilet facilities
• Sanitation
• Maintenance
Principles or Guidelines of GMP related to Manufacturing Process:
• Design and construct the facilities and equipment’s properly
• Follow written procedures and instructions
• Documentation
• Validation (Checking and provide the accurate process)
• Monitor the facilities and equipment
• Follow-up the Standard Operating Procedures and Instructions
• Design, Develop and Demonstrate the Job competence

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• Control components and products related to process

• Conduct planned and frequent audits and inspections
GMP Categories:
1. Sale:
• No distributor or importer should sell a drug unless it has been properly manufactured,
packaged, labelled tested and stored.
2. Premises and Cleaning:
• The premises should be effectively cleaned.
• It should prevent the contamination.
• The condition of equipment should be good.
• The equipment’s should be in good state of repair.
3. Personnel:
• Provide the appropriate education, training and experience for the staff.
• Maintain the sufficient number of staff.
4. Sanitation:
• Limit the sources and types of contamination.
• Perform the regular cleaning for equipment and facilities
• Take action against pest.
• Monitor the environment.
5. Raw Material, Packaging Material and Finished Product Testing:
• Test each lot or batch of raw materials to confirm the identity of raw materials and
assure the quality of the drug in product.
• Collect and test the incoming samples before use.
• Only approved test methods and specifications are used.
• The results must conform to specifications for release.
• Maintain transportation and storage records.
6. Manufacturing Control:
• Follow the well-established written procedures like Master formulae, Manufacturing
order and Packaging order.
• The critical process in the manufacturing should be validated.
• Self-inspection programs should be conducted.
7. Quality Control Department:
• It is responsible for Day-to-Day control of quality within the company.
• It is responsible for analytical testing of incoming raw materials and packaging
components.
• I t is responsible for selection of vendors.
• It is responsible for the inspection of plant environment.
• To perform the stability studies.
• To review the batch records and labels.
• To conduct the training and audits.
8. Samples:
• Retain samples of each lot of raw materials and finished product for a specified period
of time.
9. Stability:

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• To establish the length of time in which the product meets all the specifications.
• Monitor the drug for the specified period of time.
10. Sterile Products:
• Packaged in separate enclosed area by trained personnel using specified methods that
ensure sterility of the product.
11. Records:
• Document all GMP activities performed.
• Use Good Documentation Practices (GDP).
• The records must be readily available.
12. Good Documentation Practices (GDP):
• It means, the documentation must be:
▪ Permanent
▪ Clear, Concise
▪ Accurate
TOTAL QUALITY MANAGEMENT (TQM)
Definition:
➢ Total Quality Management is defined as an art of handling to achieve the product or services
with the high quality.
OR
➢ Total Quality Management is defined as a method by which management and employees
can become involved in continuous improvement of product, goods and services for the
increase of market position or business.
OR
➢ It is defined as a total degree of inherent characteristics for the art of handling, controlling
to improve the product quality at each and every step.
➢ The word “Total Quality Management (TQM)” is introduced by “Dr. W. Edward Deming”
in Japan in 1950 and the word was popular since the early 1980’s.
Objective:
• To improve quality of product continuously.
• To maintain the relationship between employee and customer.
Elements of TQM:

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1. Foundation
a. Ethics:
• Ethics are two types. They are:
➢ Organizational Ethics, it establishes a business code of ethics that set up
guidelines to all the employees to adhere the performance or work.
➢ Individual Ethics, it refers to the personal rights.
b. Integrity:
• The Work should have honesty, morals, values fairness and sincerity.
c. Trust:
• Trust is important to work.
2. Building Bricks:
a. Training:
• The proper training and training should be conducted by the company.
b. Team Work:
• Improve the job competence among the employees.
c. Leadership:
• Company has to develop the leadership qualities among the employees.
3. Binding Mortal:
Communication:
• Company has to develop the communication among the employees and as well as
customer for the improvement of quality product.
4. Roof:
Recognition:
• Company has to recognize and give the achievements for the team who worked for
the company and also provide suggestions.

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Advantages of TQM:
• It increases Product sale.
• It strengthens the company’s position in market.
• It eliminates the defects and waste.
• Increases the customer focus and satisfction.
• It improves the cost management.
Philosophies of TQM:
The Philosophies of TQM was developed by six different scientists. The philosophers are
1. Dr. W. Edwards Deming
2. Dr. Joseph M Juran
3. Armand V Feigenbaum
4. Philip Crosby
5. Walter A Shewhart
6. Genichi Taguchi
These scientists are said to determine the degree of success in market competition and also
these scientists are called as “Quality Gurus”.
1. Dr. W. Edwards Deming Philosophie:
Dr. Deming is the person who coined the name TQM in 1950’s.
Dr. Deming has planned a quality improvement cycle which called as “Dr. Deming Wheel for
Continuous Improvement”.
The Dr. Demings Wheel for continuous improvement which contain
A. Plan
B. Do
C. Check
D. Act

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T RESHMA, ASSISTANT PROFESSOR, DEPT. OF PQA - RIPER

And also suggested a set of 14 points for better quality as follows:

• Create Constancy of Purpose
• Follow a new philosophy
• Establish quality measurements
• Introduce new and modern methods in job training
• Take actions against problems
• Minimize the total cost
• Leadership
• Breakdown the barriers between department
• Planning without defects
• Evaluate the cost of quality
• Recognition for contributors
• Self-improvement program can be conducted
• Establish quality councils
• Maintain Continuously
2. Dr. Joseph M Juran Philosophie:
Dr. Joseph M Juran Philosophie defined, Quality should be “Fit for Use”.
And also Dr. Joseph M Juran Philosophie suggested a “Triology Process”, which includes
A. Quality Planning
B. Quality Control
C. Quality Improvement
INTERNATIONAL CONFERENCE ON HARMONIZATION (ICH)
ICH is a technical requirement for pharmaceutical registration of clinical trials on human use.
It is a joint commission which involves industry as private sector and regulatory body as
government sector and together work in scientific and technical discussion of testing procedure
which is required to ensure the “Quality, Safety and Efficacy” of the product.
ICH is started in 1990 and it is a non-profit organization.
ICH is formed combinedly by Europe, Japan and USA.
Objectives:
• To make recommendations to achieve the greater harmonization.
• To improve the efficacy of New Drug Development (NDD) and Registration
Process.
• To improve the public health by reducing the duplication of work and human trials
and also minimize the use of animals.
Purpose:
ICH has formed based on Thalidomide tragedy in Europe in 1960. So, ICH has decided to
provide guidelines for evaluating the data on quality, safety and efficacy of new mw=edicinal
products.

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Participants of ICH:
The participants of ICH include,
1. Regulatory members
2. Industrial members
3. Other members
1. Regulatory members:
• European Union from Europe
• Food and Drug Administration from USA
• Ministry of Health, Labor and Welfare (MHLW) from Japan
• Ministry of Food and Drug Safety (MFDS) from Korea
2. Industrial members:
• World Self-Medication Industry (WSMI)
• Biotechnology Innovation Organization (BIO)
• Pharmaceutical Research of Manufacturer of America (PRMA)
• Japan Pharmaceutical Manufacturer Associations (JAMA)
3. Other members:
• World Health Organization
• European Free Trade Association (EFTA)
• International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
Process of Harmonization:
1. Formal ICH Procedure: It deals with the new topic for harmonization.
2. Question and Answer Procedure: Clarification for an existing ICH guideline.
3. Revision Procedure: When any existing ICH guidelines are invalid or any new data has to
be added.
4. Maintenance Procedure: It is applicable only for alternation and maintenance of process.
5. Implementation Procedure: To implement and the follow the procedure.
Overview of QSEM:
1. Quality (Q1-Q14) : It involves chemical and pharmaceutical quality
maintenance.
2. Safety (S1-S13) : It deals with in-vivo and in-vitro pharmaceutical
testing.
3. Efficacy (E1-E21) : Clinical study on human beings.
4. Multidisciplinary (M1-M15) : If QSE is not fit, then ‘M’ guidelines are used.
Q Series Guidelines:
The Q series guidelines of ICH is as follows:
Q1 : Stability
Q2 : Analytical Validation
Q3 : Impurities
Q4 : Pharmacopoeias

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T RESHMA, ASSISTANT PROFESSOR, DEPT. OF PQA - RIPER

Q5 : Quality of Biotechnological Products

Q6 : Specifications
Q7 : Good Manufacturing Practices
Q8 : Pharmaceutical Development
Q9 : Quality Risk Management (QRM)
Q10 : Pharmaceutical Quality System
Q11 : Development and Manufacture of Drug substances
Q12 : Lifecycle Management
Q13 : Continuous development and manufacture of Drug substances and Drug
products
Q14 : Analytical Procedures
ICH STABILITY TESTING GUIDELINES
Q1A – Q1F : STABILITY
Q1A : Stability testing of new drug substances and drug products
Q1B : Photostability testing of new drug substances and drug products
Q1C : Stability testing of new dosage forms
Q1D : Bracketing and matrixing designs for stability testing of new drug
substances and drug products
Q1E : Evaluation of stability data
Q1F : Stability data package for registration applications in climatic zone III
and IV
QUALITY BY DESIGN (QbD)
The QbD was introduced by Dr. Joseph M Juran, who is also called as “Father of QbD”.
Definition:
It is defined as a systemic approach to the development which beings with pre-defined
objectives, emphasizes product, Process understanding and process control based on sound
Science and Quality Risk Management (QRM).
Elements of QbD:
The elements of QbD include,
1. Quality Target Product Profile
2. Critical Quality Attributes
3. Critical Process Parameters
4. Design Space
5. Quality Risk Management
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6. Control Strategy
1. Quality Target Product Profile:
It is defined as the quality attributes that ideally will be achieved to ensure that the desired
quality, safety and efficacy of the drug product.
E.g.
Dosage form
Dose
Route of administration
Pharmacokinetic Properties
2. Critical Quality Attributes:
CQAs are the physical, chemical, biological, or microbiological properties that directly impact
the product's quality, safety, and efficacy. They are determined through risk assessment and
scientific understanding of the product and manufacturing process. CQAs provide the basis for
establishing in-process controls and acceptance criteria for the final product.
3. Critical Process Parameters:
Critical Process Parameters play a vital role in the overall success and efficiency of
manufacturing processes. By identifying, understanding, and optimizing these parameters,
manufacturers can achieve significant improvements in product quality, process efficiency, and
regulatory compliance.
4. Design Space:
As per ICH quality guideline Q8, it is a multidimensional combination of input variables and
process parameters that demonstrate a high probability of producing a quality product. It is
established through the use of statistical models, experimental data, and scientific
understanding of the manufacturing process. The design space enables flexibility in process
adjustments and optimization without compromising product quality.
5. Quality Risk Management (QRM):
As per ICH quality guideline Q9, it is a systematic process of assessing, control, communicate
and review the potential risks in the development and manufacturing of pharmaceutical
products. Risk management is an ongoing process that ensures product quality by monitoring
and controlling identified risks throughout the product lifecycle.
6. Control Strategy:
As per ICH quality guideline Q10, it is a comprehensive approach to monitoring and
controlling critical process parameters (CPPs) and material attributes throughout the
manufacturing process to ensure consistent product quality.

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Tools of QbD:
1. Risk Assessment:
Risk assessment is the systematic process of identifying, evaluating, and prioritizing potential
risks that may affect product quality. Tools such as Failure Mode and Effects Analysis (FMEA),
Hazard Analysis and Critical Control Points (HACCP), and Ishikawa (fishbone) diagrams can
be used to conduct risk assessments.
2. Design of Experiments (DoE):
DoE is a statistical method used to systematically plan, conduct, and analyze experiments to
evaluate the effects of multiple variables on a response. By using DoE, researchers can gain a
better understanding of the critical process parameters (CPPs) and the relationships between
them, leading to more efficient process optimization.
3. Process Analytical Technology (PAT):
PAT is a set of tools and techniques used for real-time monitoring and control of critical quality
attributes (CQAs) and Critical Process Parameters (CPPs) during the manufacturing process.
The use of PAT enables more robust process control and optimization, leading to improved
product quality and reduced manufacturing costs.
4. Continuous Improvement:
Continuous improvement is a core principle of QbD that involves the ongoing evaluation of
the product and process performance to identify opportunities for improvement. It may involve
the implementation of new technologies, process optimization, or other changes aimed at
enhancing product quality and reducing variability.
INTERNATIONAL SATNDARD ORGANIZATION (ISO)
OR
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO)
International Organization for Standardization (ISO) is an independent, non-governmental,
international organization that develops and publishes standards to ensure the quality, safety,
efficiency, and compatibility of products, services, and systems across various industries.
It is established in 1947, ISO is headquartered in Geneva, Switzerland, and comprises a
network of national standards bodies from over 160 countries and India is also a national body
in ISO.
ISO's primary objective is to facilitate international trade by providing a common set of
standards that help to harmonize technical specifications, reduce misunderstandings, promote
and compatibility and interoperability among products and systems worldwide.
ISO is derived from a Greek word “ISOS” which means Equal.

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ISO 9000 Series:

Definition:
These standards are focused on quality management systems and provide guidelines to help
organizations consistently meet customer requirements, enhance customer satisfaction, and
continually improve their processes.
OR
It is a series of standards and development which is published by the ISO that defines, establish
and maintain an effective quality assurance system for manufacturing of drug products and
industrial services.
Overview of ISO 9000:
ISO 9000 : Quality management system guidelines for fundamental equipment’s.
ISO 9001 : Quality management system guidelines for requirement of more equipment’s.
ISO 9002 : Installation and management of computer software.
ISO 9003 : Quality assurance final inspection.
ISO 9004 : Quality management system guidelines for continuous improvement.
Benefits of ISO 9000:
• It is a base company for Quality Assurance certification, only third-party deals with the
industry.
• It is suitable for small- and large-scale industry.
• It communicates a positive message to staff and customers.
• It reduces errors and customer complaints.
• It increases the internal management, efficiency, profit and productivity of drug
product.
• It reduces the wastage.
Elements of ISO 9000:
• Management Responsibility
• Quality system
• Design control
• Customer focus
• Process control
• Inspection and Checking Inspection status
• Control of Non-Conformities
• Corrective Action and Preventive Action
• Handling
• Storage
• Packaging
• Training
• Maintenance of records

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T RESHMA, ASSISTANT PROFESSOR, DEPT. OF PQA - RIPER

ISO 14000 Series:

Definition:
The ISO 14000 series covers environmental management systems and provides a framework
for organizations to manage their environmental responsibilities effectively.
OR
It is a set of rules and standards created to help the companies or industries to reduce the waste
and environmental damage.
Overview of ISO14000:
ISO 14000 : Environmental management system for general guideline on implementation.
ISO 14001 : Criteria plan or set for Environmental management system.
ISO 14006 : Guidelines to incorporate Eco-design.
ISO 14020 : Standards about environmental labelling.
ISO 14030 : Environmental evaluation guidelines.
ISO 14064 : Guidelines for greenhouse gases.
Benefits of ISO 14000:
• It increases the customer satisfaction.
• The resources are used more efficiently.
• It reduces waste.
• It increases the customer trust.
• It increases the marketing and profit for the company.
Elements of ISO 14000:
• Environmental Policy
• Planning
• Study and Correct
• Management Review
• Continuous Improvement
• Implementation
Process or Steps for ISO Registration:

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After issue of certificate, frequent inspection for every 6 months and one year. Based on the
inspection the certification has been renewed.
The validity of ISO certification id 3 years.
NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION
LABIRATORY (NABL)
National Accreditation Board for testing and calibration laboratory is a Autonomous body,
which is under the
• Department of Science and Technology
• Government of India
The NABL has registered under the “Societies act” in 1992.
In 2016, it has established links with international bodies like,

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• Asian Pacific Laboratory Accreditation Co-operation

• International Laboratory Accreditation Co-operation
Objectives:
• To provide Accreditation to testing and calibration laboratories.
• To provide Accreditation to clinical laboratories.
• It is a third-party for assessment of quality.
Benefits of NABL:
• Increased business potential due to enhanced customer confidence and satisfaction.
• Save money and time due to reduction of re-testing.
• Increased confidence in testing and calibration reports which issued by NABL.
• Better control of laboratory operation and feedback as they have knowledge on quality
assurance system.
• Manufacturers of accredited laboratories will have greater access for their products in
both national and international market.
Scope or Principle of NABL:
• It is present or grant in all areas of,
o Science
o Engineering
o Medical testing
• The international standards followed by NABL are,
o ISO/IEC : 17025:2005 : Testing and Calibration
o ISO : 15189:2007 : Medical testing
o ISO : 17043:2010 : Proficiency testing
• NABL is Accredited to,
o Testing for Biological, Chemical, Electronics etc.
o Calibration for Electro, Technical, Mechanical etc.
o Medical for Clinical biochemistry, Clinical pathology, Genetic, Cytopathology,
Hematology etc.
Process or Procedure of NABL Accreditation:

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