JSS Academy of Higher Education & Research

(Deemed to be University)
Accredited ‘A+’ Grade by NAAC
Sri Shivarathreeshwara Nagara, Mysuru – 570 015
Karnataka, INDIA

M. Pharm Digital Education Program

 FACULTY OF PHARMACY
M. Pharm (Quality Assurance)

MQA 103T QUALITY CONTROL & QUALITY ASSURANCE

UNIT- 1
INTRODUCTION

SUB TOPIC (1/12):

Concept, Evolution and Scope of Quality Control & Quality Assurance

Dr. N. KRISHNA VENI, JSSCPO

 QUALITY
• Quality is never an accident; it is always the result of high intention, sincere effort,
intelligent direction and skilful execution; it represents the wise choice of many
alternatives.

Why quality:
• Change in pharmaceutical environment due to globalisation, increased competition,
cost constraints, demand for efficiency, international regulations and
product/process complexity.

• To manufacture & deliver consistently zero defect products to the patients.

• The quality, efficacy and safety attributes of products must be ensured so that the
consumer health is not compromised.
 IGNORANCE OF QUALITY

Manufacturing
process,
packaging,
transportation, Lack of
therapeutic
storage effect, toxic and
condition MEDICINE adverse
reaction, waste
QUALITY of limited
financial
resources, loss
of credibility
• QUALITY: a measure of excellence or a state of being free from defects, deficiencies
and significant variations.

• QUALITY ASSURANCE: Obtaining confidence that, required quality of product or

service is satisfactory for their intended use.

• QUALITY CONTROL: part of GMP concerned with sampling, testing and

specifications.
 QUALITY CULTURE
• Support for the quality organisation
• Actions more than words
• Investment in quality
• Quality involved in relevant business decisions
• The quality of work you accept becomes the
organisations standard
• Organizational structure: assures that quality is
independent and not subordinate to other
organisational unit
 QUALITY RESPONSIBILITY

• Quality is the collective responsibility of

every individuals in an organisation.
• Quality initiatives are successful only when it
is driven from top management to the lower
levels of management.
 QbD approach
• Quality is not an add on: it begins with research and
development.

• Product quality criteria must be established

• Detailed specifications provide quantitative parameters for

measurement.

• Written procedures document how quality is attained and

maintained.

• Continuous monitoring (sampling, testing) to confirm quality is

being built into the product
QUALITY CONTROL AND QUALITY
ASSURANCE
QUALITY CONTROL:
• This was also a post production activity to detect defect in the finished products
using techniques to achieve, maintain and improve quality standards of the
products and services.

• Adherence to standards and sorting out rejects were its concerns.

• Unlike the inspection, it had the systems of measurement and appraisal of product,
material and production processes, but at the end time and limited to supervisory
status.
• Quality Control (QC) is a system of routine technical activities, to measure and
control the quality of the inventory as it is being developed. The QC system is
designed to:
• (i) Provide routine and consistent checks to ensure data integrity, correctness, and
completeness;
• (ii) Identify and address errors and omissions;
• (iii) Document and archive inventory material and record all QC activities.
• QC activities include general methods such as accuracy checks on data acquisition
and calculations and the use of approved standardised procedures for emission
calculations, measurements, estimating uncertainties, archiving information and
reporting. Higher tier QC activities include technical reviews of source categories,
activity and emission factor data, and methods.
QUALITY ASSURANCE
• This is a third evolutionary phase which contains all planned and systematic actions necessary for
compliance of given requirements for quality of a product or service meeting quality needs of the
customer.
• So QA works on compliance of procedure and conformity of the product to laid down specifications
through production and operation management using statistical process control/statistical quality
control and set of documentation tools.
• This is an online action having the system of appraisal. Prevention and measurement activities with a
management status.
• In QA there is a system of auditing by third party. EG: government or any other agency.
• “The sum total of the organised arrangements made with the object of ensuring that medicinal
products are of the quality required for their intended use”.
• The formal definition of Quality is:
• “The totality of features and characteristics of a product or service which bear on its ability to meet
stated or implied needs”.
• “Assuring the quality of the product from the day of design till the consumption of the product.”
• Quality Assurance (QA) activities include a planned system of review procedures conducted by
personnel not directly involved in the inventory compilation/development process. Reviews,
preferably by independent third parties, should be performed upon a finalised inventory following
the implementation of QC procedures. Reviews verify that data quality objectives were met, ensure
that the inventory represents the best possible estimates of emissions and sinks given the current state
of scientific knowledge and data available, and support the effectiveness of the QC programme.
FUNCTIONS OF QA IN AN INDUSTRY
• To ensure
• Raw materials used in the manufacturing are approved and procured from
approved vendors.
• All data's are recorded as per c GMP and is reviewed for accuracy and
traceability.
• Procedures are in place for performing the activities, operating and calibrating
the equipment.
• Quality is built up in the plant, process and product. That a robust quality system
is in place.
• Trainings like induction, on job, scheduled and after any changes are conducted
to respective individuals on time.
• To prepare and approve quality policy, quality objectives, quality manual and
VMP.
• Periodic monitoring of the quality objectives.
• Monitors all validation & stability activities are completed as per the schedule.
• Ensures that all deviations, OOS/OOT and market complaints are logged, investigated to identify
the root cause so at to take CAPA to prevent recurrence.
• Preparation of annual product quality reports, trending of data, determining product and process
performance.
• To arrange and conduct the self inspection, identify gaps and take CAPA.
• Review of related batch manufacturing records and QC resting data prior to release of any batch.
 Quality Control

Routine activity:
RM & PM analysis
Intermediate stage analysis Activities are managed through:
Finished products analysis Instrumental analysis
Stability studies Chemical analysis
Non routine activity:
Calibration & preventive maintenance of
Microbiological analysis
instruments. Packaging materials analysis
Preparation of reference/working standards
Method development/validation
FUNCTIONS OF QC
• Preparation of specifications for testing of materials and products.
• Carrying out sampling and testing of materials or products.
• Environmental monitoring.
• Conducting stability studies.
• Investigating test failures such as OOS/OOT/OOAC/OOAL.
• Analytical method validation
• Evaluation of complaint samples.
S. No Criteria Quality assurance Quality control
1 Focus To prevent defects with a focus on the process To identify defects in the finished
products
2 Goal To improve development and test processes so to identify defects after a product is
that defects do not arise developed and before it is released
3 How Establish a good quality management system Finding sources of quality problems
and assessment of its adequacy with continuous to continually meet customers
monitoring requirement.
4 What Prevention of quality problems through planned Analytical techniques used to
and systematic activities maintain the product quality and
process
5 Responsibility Everyone on the team Of a specific team that tests the
product for defects
6 As a tool Managerial tool Corrective tool