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Concept of QA & QC

The document discusses the concepts of quality assurance (QA) and quality control (QC). It defines QA and QC, compares their goals and responsibilities, and explains their relationship to good manufacturing practices (GMP). QA focuses on preventing defects through process management while QC identifies defects in finished products. Together they ensure products meet quality standards. GMP is the part of QA that ensures consistent manufacturing quality for intended use.

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Vidit Oberoi
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210 views

Concept of QA & QC

The document discusses the concepts of quality assurance (QA) and quality control (QC). It defines QA and QC, compares their goals and responsibilities, and explains their relationship to good manufacturing practices (GMP). QA focuses on preventing defects through process management while QC identifies defects in finished products. Together they ensure products meet quality standards. GMP is the part of QA that ensures consistent manufacturing quality for intended use.

Uploaded by

Vidit Oberoi
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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Concept of QA & QC

Dr. Misari Patel


Assistant Professor
Department of Quality Assurance
What is Quality ?

 In manufacturing, a measure of excellence or a state of being free


from defects, deficiencies and significant variations. It is brought
about by strict and consistent commitment to certain standards that
achieve uniformity of a product in order to satisfy specific customer or
user requirements.
(http://www.businessdictionary.com)
 The totality of features and characteristics of a product or service that
bears its ability to satisfy stated or implied needs.
(ISO 8402-1986)
Common Meanings of Quality

 Quality is fitness for use


 Quality is meeting customers expectations
 Quality is exceeding the customers expectations
 Quality is superiority to competitors
Definition: 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, and inspections.
 ISO 9000 defines as "part of quality management focused on
providing confidence that quality requirements will be fulfilled“.
Definition: Quality Control

 ISO 9000 defines quality control as "A part of quality management


focused on fulfilling quality requirements".
 It is that part of GMP concerned with sampling, specification &
testing, documentation & release procedures which ensure that
the necessary & relevant tests are performed & the product is
released for use only after ascertaining it’s quality.
Difference between QA and QC

Definition

 QA is a set of activities for  QC is a set of activities for


ensuring quality in the ensuring quality in products.
processes by which products The activities focus on
are developed. identifying defects in the
 QA is a managerial tool. actual products produced.
 QC is a corrective tool.
Difference between QA and QC

What are its goals and on what does it focus?

 QA aims to prevent defects  QC aims to identify (and


with a focus on the process correct) defects in the
used to make the product. It finished product. Quality
is a proactive quality control, therefore, is a
reactive process.
process.
 The goal of QC is to identify
 The goal of QA is to improve defects after a product is
development and test developed and before it's
processes so that defects do released.
not arise when the product is
being developed.
Difference between QA and QC

What and how does it work?

 Prevention of quality  The activities or techniques


problems through planned used to achieve and
and systematic activities maintain the product
including documentation. quality, process and service.
 Finding & eliminating sources
 Establish a good quality of quality problems through
management system and tools & equipment so that
the assessment of its customer's requirements are
adequacy. Periodic continually met.
conformance audits of the
operations of the system.
Difference between QA and QC

Whose responsibility is it and the example of it?

 Everyone on the team  Quality control is usually the


involved in developing the responsibility of a specific
product is responsible for team that tests the product
quality assurance. for defects.
 Verification is an example of  Validation is an example of
QA. QC.
Responsibilities of QA

 The QA department is responsible for ensuring that the quality policies


adopted by a company are followed.
 It helps to identify and prepare the necessary SOPs relative to the control of
quality.
 It must determine that the product meets all the applicable specifications
and that it was manufactured according to the internal standards of GMP.
 QA also holds responsible for quality monitoring or audit function.
 QA functions to assess operations continually and to advise and guide them
towards full compliance.
Responsibilities of QC

 QC is responsible for the day-to-day control of quality within the company.


 This department is responsible for analytical testing of incoming raw materials and
inspection of packaging components, including labelling.
 They conduct in-process testing when required, perform environmental monitoring,
and inspect operations for compliance.
 They also conduct the required tests on finished dosage form.
 QC plays a major role in the selection of qualified vendors from whom raw materials
are purchased. Testing of representative samples is required, and in many cases, an
audit of vendor’s operations is necessary to determine their suitability and degree of
compliance with GMPs prior to their being approved.
 The environmental areas for manufacturing of various dosage forms are tested and
inspected by QC department.
What is GMP ?

 GMP is that part of Quality assurance which ensures that the products are
consistently manufactured and controlled to the Quality standards appropriate to
their intended use.
 A set of principles and procedures which, when followed by manufacturers for
therapeutic goods, helps ensure that the products manufacture will have the
required quality.
 A basic tenet of GMP is that quality cannot be tested into a batch of product but
must be built into each batch of product during all stages of the manufacturing
process.
 It is designed to minimize the risks involved in any pharmaceutical production that
cannot be eliminated through testing the final product.
Relationship Between QA, QC and
GMP
 QA is the sum total of the organized arrangements with the objective
of ensuring that products will be of the quality required for their
intended use.
 GMP is that part of Quality Assurance aimed at ensuring that products
are consistently manufactured to a quality appropriate to their
intended use.
 QC is that part of GMP concerned with sampling, specification &
testing, documentation & release procedures which ensure that the
necessary & relevant tests are performed & the product is released for
use only after ascertaining it’s quality
Quality Assurance

Good Manufacturing
Practices

Quality Control
Benefits of Quality Assurance and
Quality Control

 It gives you a high quality output.


 It increases the efficiency of operations.
 It brings customer satisfaction, which affects your brand and
helps you grow your business.
 If your product is of good quality, you will not need much
rework and there will not be much after-sale support required.
This will help you save a lot of money.
 A high level of confidence and a motivated team.

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