6a. Quality Assurance and Control
6a. Quality Assurance and Control
6a. Quality Assurance and Control
Assurance and
Quality
Control
Definitions
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"
Definitions
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 QC is a set of
activities for ensuring activities for ensuring
quality in the quality in products.
processes by which The activities focus
products are on identifying defects
developed. in the actual
QA is a managerial products produced.
tool QC is a corrective
tool
Difference between QA and QC
(Contd.)
What are its goals and
on what does it
focus?
QA aims to prevent QC aims to identify
defects with a focus on (and correct) defects in
the process used to the finished product.
make the product. It is Quality control,
a proactive quality therefore, is a reactive
process. process.
The goal of QA is to The goal of QC is to
improve development identify defects after a
and test processes so product is developed
that defects do not and before it's
arise when the product released.
is being developed.
Difference between QA and QC
(Contd.)
What and how does it
work?
Prevention of quality The activities or
problems through techniques used to
planned and systematic achieve and maintain
activities including the product quality,
documentation. process and service.
Establish a good quality Finding & eliminating
management system sources of quality
and the assessment of problems through tools
its adequacy. Periodic & equipment so that
conformance audits of customer's
the operations of the requirements are
system. continually met.
Difference between QA and QC
(Contd.)
Whose responsibility is it and
what is the example of it?
Monitoring of personnel
Quality Assurance
Good Manufacturing
Practices
Quality Control
Total Quality Control
The concept of total quality control refers to the
process of striving to produce a perfect product by a
series of measures requiring an organised effort at
every stage in production.
Although the responsibility for assuring product
quality belongs principally to QA personnel, it involves
many departments and disciplines within a company.
To be effective, it must be supported by team effort.
Quality must be built into a drug product during
product and process, and it is influenced by the
physical plant design, space, ventilation, cleanliness
and sanitation during routine production.
Total Quality Control (Contd.)
In products and process designing, it considers
many parameters like:
- Materials
- In-process and product control
- Specification and tests for active ingredients,
excipients
- Specific stability procedures of the product
- Freedom from microbial contamination and
proper storage
- Containers, packaging and labelling
- Product protection from moisture, light, volatility,
and drug/package interaction
Total Quality Management
According to ISO, TQM is defined as:
"A management approach of an
organisation centred on quality, based on
the participation of all its members and
aiming at long term success through
customer satisfaction and benefits to all
members of the organisation and society."
Activities in TQM
TQM is the foundation for activities, which include:
Commitment by senior management and all employees
Meeting customer requirements
Reducing development cycle times
Just in time/demand flow manufacturing
Improvement teams
Reducing product and service costs
Systems to facilitate improvement
Line management ownership
Employee involvement and empowerment
Recognition and celebration
Challenging quantified goals and benchmarking
Focus on processes / improvement plans
Specific incorporation in strategic planning
Functions of TQM
Product quality criteria are established, and
detailed specifications are written. Meticulous,
written procedures must be prepared for
production and control. Raw material must be
characterised and then purchased from
reputable, approved suppliers.
Facilities must be designed, constructed, and
controlled to provide the proper stable
environment for protecting the integrity of
products. Equipments must be selected that is
efficient and can be cleaned readily and
sanitised.
Functions of TQM (Contd.)
Personnel must be trained properly. The
directions they use must be in writing,
approved by responsible individuals.
Distribution departments are responsible
for controlling the shipping and handling
of products, using inventory-control
systems.
The marketing department must be
sensitive to the costumers’ needs and be
responsive to complaints.
Functions of TQM (Contd.)
QA is ever present and gives approval
only after assessing and being assured
that the entire production process has
been completed satisfactorily and that all
the aspects of the GMPs have been
satisfied.
Advantages of TQM
Initial
introduction cost.
Benefits may not be seen for several
years.
Workers may be resistant to change
Major Keywords of Quality
Assurance
Calibration
Validation
Qualification
Calibration
Calibrationis defined as operation that,
under specified conditions, in a first step,
establishes a relation between the quantity
values with measurement uncertainties
provided by measurement standards and
corresponding indications with associated
measurement uncertainties (of the calibrated
instrument or secondary standard) and, in a
second step, uses this information to
establish a relation for obtaining a
measurement result from an indication.
Validation
Validation is a process of establishing
documentary evidence demonstrating that a
procedure, process, or activity carried out in
production or testing maintains the desired
level of compliance at all stages. In Pharma
Industry it is very important apart from final
testing and compliance of product with
standard that the process adapted to produce
itself must assure that process will
consistently produce the expected results.
Validation (Contd.)
Since a wide variety of procedures, processes, and
activities need to be validated, the field of validation
is divided into a number of subsections including the
following:
Equipment validation
Facilities validation
HVAC system validation (Heating Ventilation and Air
Conditioning)
Cleaning validation
Process Validation
Analytical method validation
Computer system validation
Packaging validation
Cold chain validation
Types of Validation
Prospective Concurrent
Validation Validation
Validation
Retrospectiv Repeated
e
Validation Validatio
n
1. Prospective Validation
Prospective validation is carried out during the development
stage by means of a risk analysis of the production process,
which is broken down into individual steps: these are then
evaluated on the basis of past experience to determine
whether they might lead to critical situations.
Where possible critical situations are identified, the risk is
evaluated, the potential causes are investigated and
assessed for probability and extent, the trial plans are drawn
up, and the priorities set. The trials are then performed and
evaluated, and an overall assessment is made. If, at the end,
the results are acceptable, the process is satisfactory.
Unsatisfactory processes must be modified and improved
until a validation exercise proves them to be satisfactory.
This form of validation is essential in order to limit the risk of
errors occurring on the production scale, e.g. in the
preparation of injectable products.
2. Concurrent Validation
74
Thank
You!!!