Introduction to Quality assurance. According to U.S.F.D.A “Quality should be built into the product, and testing alone cannot be relied on to ensure product quality”. Building Quality into the product involves having controls at every stage of manufacturing and not only terminal controls. These include controls on all input resources like: people, facilities, equipment, materials, process and testing etc.

1. DISCOVER . LEARN . EMPOWER
Introduction to Quality Assurance (Q.A)
UNIVERSITY INSTITUTE OF PHARMA SCIENCES
Pharm D
Pharmaceutical Analysis (21PST-324)
Mr. Yunes Alsayadi

2. 2
Pharmaceutical Analysis
Course Outcome
Course Outcome
1 Understand the interaction of matter with
electromagnetic radiations and its applications in
drug analysis Students will carry out the animal
experiments confidently
Understanding
2 they Understand the chromatographic separation
and analysis of drugs
Learning
3 Perform quantitative & qualitative analysis of drugs
using various analytical
Instruments
Remembering

3. Background of Quality Assurance
The word “Quality” has been
originated from Latin word
QUALITAS.
QUALITAS means General
excellence or a distinctive feature.
Quality can be defined as the
standard of something as
measured against other things of a
similar kind; the degree of
excellence of something (Google,
2022)
But what does the quality have to
do with Pharmaceuticals?
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4. According to oxford dictionary Quality means
 “A standard of how good something is as measured against other similar things.”
Standard
Measurement
Goodness
Comparison
It means “You are trying to measure something(quality attributes) with a standard
to know where the object stands with the expectation of its quality attributes
being assured
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5. Pharmaceutical Quality
As in most manufacturing processes, the quality of a final pharmaceutical
product is determined by the starting materials, equipment, and technical know-
how that go into producing and packaging it.
A medicine is a dynamic product whose color, consistency, weight, and even
chemical identity can change between manufacture and ultimate consumption.
A medicine that passes all laboratory tests upon receipt may be useless within a
few months if the packaging, storage, and transportation conditions are not
maintained properly.
The purpose of quality assurance in pharmaceutical supply systems is to help
ensure that each medicine reaching a patient is safe, effective, and of appropriate
quality.
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6. Remember …
The definition of quality is conformation to requirement.
The system to be used is prevention.
The performance standard is zero defects.
Measurement is based on the cost of quality.
Every pharmaceutical product must meet four attributes namely identity,
strength, safety and purity to achieve the desired effectiveness of the
product.
In short “achieving quality” means achieving these attributes for product.
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7. Quality Concept
According to U.S.F.D.A
“Quality should be built into the product, and testing alone cannot be relied on to
ensure product quality”.
Building Quality into the product involves having controls at every stage of
manufacturing and not only terminal controls.
These include controls on all input resources like:
people,
facilities,
equipment,
materials,
 process
and testing etc.
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8. Quality Unit
Divided into two parts
Quality control
Quality Assurance
Quality control
Consist of testing of selected process materials and finished products to evaluate
the performance of the manufacturing process and to ensure adherence to proper
specifications and limits.
Quality Assurance
It includes the review and approval of all procedures related to production,
maintenance and review of associated records and auditing and performing trend
analysis.
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9. Pharmaceutical quality assurance framework
The following five elements are critical to achieving the expected treatment
outcome. Using a pharmaceutical product to treat a patient presumes that
the—
• Active pharmaceutical ingredient (API) has been shown to be safe and
effective for this treatment.
• Product is of suitable quality to provide an effective outcome.
• Prescriber has accurately identified the need for the treatment.
• Prescriber or dispenser has properly instructed the patient on how to use
the product
• Patient complies with the prescribed regimen correctly.
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10. Defining and assessing pharmaceutical quality
Pharmaceutical quality is assessed as the product’s compliance with
specifications concerning identity, purity, strength, potency, and other
characteristics. Uniformity of the dosage form, bioavailability, and
stability are important characteristics that are also considered in the
specifications.
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11. Activities of Quality Assurance Dept.
1. Technology transfer
2. Validation
3. Documentation
4. Assuring quality of products
5. Quality improvement plans
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12. Consequences of poor pharmaceutical quality
A poor-quality medicine is one that does not meet specifications.
The use of poor-quality products may have undesirable clinical and
economic effects, as well as affect the credibility of the health
delivery system.
Clinical effects can include prolonged illness or death or adverse
reactions.
On the economic side, limited financial resources may be wasted on
poor-quality medicines
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13. Remember..
Lack of therapeutic effect may lead to prolonged illness or death.
Poor-quality pharmaceuticals may induce toxic or adverse reactions.
Poor pharmaceutical quality wastes money.
Poor pharmaceutical quality may seriously affect health system
credibility.
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14. Assignment
• Define Quality Assurance and Quality Control. Write a detailed note
about the differences between them (Q.A & Q.C)?
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15. THANK YOU
For queries
Email: yunes.r18@cumail.in