Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It aims to ensure that pharmaceutical products are of the quality required for their intended use. Key aspects of quality assurance include providing evidence that quality activities are being performed effectively, ensuring products meet given quality requirements, and initiating actions to dispose of non-conforming products. Quality assurance plays an important role in industries like pharmaceuticals where human safety is critical.

2. What is Quality Assurance?
According to WHOAccording to WHO
““ Quality assurance is a wide rangingQuality assurance is a wide ranging
concept covering all matters thatconcept covering all matters that
individually or collectively influence theindividually or collectively influence the
quality of a product. It is the totality of thequality of a product. It is the totality of the
arrangement made with the object ofarrangement made with the object of
ensuring that pharmaceutical products areensuring that pharmaceutical products are
of quality required for their intended use”of quality required for their intended use”

3. • The activity of providing to all concerned the
evidence needed to establish confidence that
the quality function is being performed
adequately.
• QA is the activity of providing evidence
needed to establish confidence among all
concerned, that quality-related activities are
being performed effectively.

4. • All those planned or systematic actions
necessary to provide adequate confidence
that a product or service will satisfy given
requirements for quality.
• The effort to ensure that products have the
strength, Purity, safety and efficacy.
• The effort that is needed to satisfy
consumer OR to achieve an established
standard of excellence

5. • QA assures the existence and effectiveness of
procedures that attempt to make sure - in advance
- that the expected levels of quality will be reached.
• Quality Assurance initiates the action to dispose of
non conforming products
• QA department develop and carry out procedures
that govern the product composition, manufacturing
process, test criteria or operating system which
ensures that quality function is performed
adequately.

6. • QA covers all activities from design,
development, production, installation,
servicing to documentation.
• It introduced the sayings "fit for purpose"
and "do it right the first time".
• It includes the regulation of the quality of
raw materials, assemblies, products and
components; services related to production;
and management, production, and
inspection processes.

7. Quality Assurance include following
functions-
1.To ensure that valid formulation is designed
2.To qualify the process that will be scaled up to
production size batches
3.To design validation protocol programme which
will become object of FDA’s pre-approval
clearance
4. To manufacture bio-batches for clinical
programme

8. 5.To work with production & engineering
department to develop & carry out programme
for production equipments & facilities
6.To develop validated analytical methods to allow
a. Stability programme to be carried out.
b. The testing of raw materials and finished
product.
c. The development of release specifications for
raw materials & finished product.
d. The testing of processed materials at certain
specified stages.

9. • Quality Assurance performs physical or
chemical tests that are used as the basis
for approval or rejection of individual
batches.
• QA carries out stability programme for
each product at least once a year.
• It performs analytical tests that are used to
generate validation data required by
protocol.

10. Quality Assurance is the effort taken to
ensure compliance with government
regulations for the systems, facilities and
personnel involved with manufacturing
products. These responsibilities include:
1.Batch record reviews
2.Critiques of product design
3.Process validation activity
4.Audits of other department operations

11. Master Formula Record
1. Name of product, description of dosage
form & its strength
2. List of ingredients (by whole name)
3. The qty. by w/v of each ingredient
(statement for variation in the qty.)
4. Standards & specifications of each
ingredient used in the product
5. Approved statement concerning any
calculated excess of an ingredient

12. 6. Manufacturing and control instructions,
specifications, precautions.
7. A detailed description of closures,
containers, labeling, packaging & other
finished materials.
8. Approved statement of theoretical yield at
various stages and termination of
processing.

13. Std. of Identity Quality Purity
Color formation Absorbance Color, odor
Precipitation Refractive index Acidity alkalinity
decomposition Optical rotation Inorganic salts
IR spectra Specific gravity Heavy metal
UV spectra pH
Foreign matter
Visible spectra Viscosity Residue on
evaporation
Specific reaction M.P. range
Cations /anions
Determination
Saponification
value
Acid value

14. What is Validation?
• A documented programme that provides a
high degree of assurance that a specific
process will consistently produce a
product meeting its predetermined
specifications and quality attributes.
• Process Validation is a Quality assurance
tool because it establishes a quality
standard for a specific process.

15. What is Six Sigma Methodology?
• Many organizations use
statistical process control to bring the
organization to Six Sigma levels of quality.
• So that the likelihood of an unexpected
failure is confined to six
standard deviations on the
normal distribution.
• This probability is less than four in
one-millions.

16. • Six Sigma is a set of practices originally
developed by Motorola to systematically
improve processes by eliminating defects.
• A defect is defined as nonconformity of a
product or service to its specifications.
• Originally formulated by Bill Smith at
Motorola in 1986, Six Sigma was heavily
inspired by six preceding decades of
quality improvement methodologies such
as Quality Control, TQM, and
Zero Defects.

17. Like its predecessors, Six Sigma asserts
the following:
• Continuous efforts to reduce variation in
process outputs is key to business
success
• Manufacturing and business processes
can be measured, analyzed, improved
and controlled
• Succeeding at achieving sustained quality
improvement requires commitment from
the entire organization, particularly from
top-level management

18. • The term "Six Sigma" refers to the ability
of highly capable processes to produce
output within specification.
• In particular, processes that operate with
six sigma, quality produce at defect levels
below 3.4
defects per (one) million opportunities
(DPMO).
• Six Sigma's implicit goal is to improve all
processes to that level of quality or better.

19. Methodology
• Six Sigma has two key methodologies:
1. DMAIC and
2. DMADV
both inspired by W. Edwards Deming's
Plan-Do-Check-Act Cycle:
a) DMAIC is used to improve an existing
business process, and
b) DMADV is used to create new product or
process designs for predictable, defect-free
performance.

20. DMAIC
Basic methodology consists of the following
five steps:
• Define the process improvement goals that
are consistent with customer demands and
enterprise strategy.
• Measure the current process and collect
relevant data for future comparison.
• Analyze to verify relationship and causality of
factors. Determine what the relationship is,
and attempt to ensure that all factors have
been considered.

21. • Improve or optimize the process based
upon the analysis using techniques like
Design of Experiments.
• Control to ensure that any variances are
corrected before they result in defects. Set
up pilot runs to establish
process capability, transition to production
and thereafter continuously measure the
process and institute control mechanisms.

22. DMADV
Basic methodology consists of the following five steps:
• Define the goals of the design activity that
are consistent with customer demands
and enterprise strategy.
• Measure and identify CTQs (critical to
qualities), product capabilities, production
process capability, and risk assessments.
• Analyze to develop and design
alternatives, create high-level design and
evaluate design capability to select the
best design.

23. • Design details, optimize the design, and
plan for design verification.
• Verify the design, set up pilot runs,
implement production process and
handover to process owners.
• Some people have used DMAICR
(Realize). Others contend that focusing on
the financial gains realized through Six
Sigma is counter-productive and that said
financial gains are simply byproducts of a
good process improvement.

24. Other Design for Six Sigma methodologies
Methodology & Proponent
1)DCCDI (Define, Customer Concept, Design and
Implement) - Geoff Tennant
2)DCDOV (Define, Concept, Design, Optimize, Verify) –
Uniworld
3)DMADOV (Define, Measure, Analyze, Design, Optimize
and Verify)-General Electric
4)DMEDI (Define, Measure, Explore, Develop and
Implement) –PricewaterhouseCoopers
5)IDOV (Identify, Design, Optimize and Validate)
6)I2DOV (Invent, Innovate, Develop, Optimize, Validate)

25. The following companies claim to have successfully
implemented Six Sigma in some form or another:
• Network Rail
• CSC
• Motorola
• General Electric
• Samsung
• LG
• Korea Telecom
• Precision Castparts Corp.
• 3M[1]
• Bank of America[2]
• Advanced Micro Devices[3]
• Caterpillar Inc.[4]
• Honeywell International[5]
• The Boeing Company[6]
• Amazon.com Inc.[7]
• Littlewoods Shop Direct Group[8]
• Ford [9]
• Starwood Hotels & Resorts [10]
• U.S. Army [11]
• Merrill Lynch
• U.S. Navy [12]
• CIGNA [13]
• DuPont
• UnitedHealth Group
• Teradyne

26. List of Six Sigma software packages
There are generally two classes of
software used to support Six Sigma:
• Analysis tools, which are used to perform
statistical or process analysis
• Program management tools, used to
manage and track a corporation's entire
Six Sigma program

27. Analysis tools
• SigmaFlow
• Minitab
• JMP
• SigmaXL
• RapAnalyst
• Statgraphics
• iGrafx
• Microsoft Visio
• Telelogic System Architect
• IBM WebSphere Business Modeler
• Proforma Corp. ProVision
• STATISTICA

28. Program management tools
include
• SigmaFlow
• Instantis
• PowerSteering
• iNexus
• SixNet
• Proxima Technology Centauri
• HP Mercury
• BMC Remedy.

29. CONCLUSION
• Quality Assurance department plays a
very important role in every manufacturing
or service industry.
• But it is a vital particularly in
pharmaceutical industry where a slight
negligence on the part of quality may be
fatal one.