Issues: Minimal research funding No clinical or bioequivalence centers Solutions: R&D grants Research centers University collaborationIssues: Minimal research funding No clinical or bioequivalence centers Solutions: R&D grants Research centers University collaborationIssues: Minimal research funding No clinical or bioequivalence centers Solutions: R&D grants Research centers University collaborationIssues: Minimal research funding No clinical or bioequivalence centers Solutions: R&D grants Research centers University collaborationIssues: Minimal research funding No clinical or bioequivalence centers Solutions: R&D grants Research centers University collaboration

1. Concept of Quality

2. Quality
The degree to which something meets expectations and specifications,
encompassing its characteristics, features, and overall performance.
A DEGREE OF EXCELLENCE
How well a product, service, or process fulfills its intended purpose and
satisfies the needs of its users

3. Key aspects of quality
Conformance to requirements: Quality means meeting established standards and
specifications.
Fitness for purpose: A product or service should be suitable for its intended use.
Customer satisfaction: Quality is often measured by how well a product or service
meets customer expectations and needs.
Reliability and durability: A quality product should be dependable and last a long
time.
Performance and functionality: Quality often implies effective and efficient
performance of the product or service.
Aesthetics and perceived quality: While not always measurable, the appearance
and overall impression of quality can also be important.

4. Quality as product, service and process
Product quality: A well-made product with high-quality materials and
features.
Service quality: Friendly and efficient customer service, prompt
response to inquiries, and effective problem resolution.
Process quality: A streamlined and efficient process that minimizes
errors and waste

5. Why it is important?
Customer satisfaction and loyalty: High-quality products and services lead to happier
customers who are more likely to return and recommend the business.
Competitive advantage: A reputation for quality can help businesses stand out from the
competition and attract more customers.
Cost reduction: By focusing on quality, businesses can reduce waste, rework, and warranty
claims.
Improved efficiency and productivity: Quality processes can lead to more efficient
operations and increased productivity
Manufacturing: Quality relates to product uniformity and defect-free production.
Healthcare/Pharmacy: Quality implies patient safety, efficacy of medicines, and regulatory
compliance.
Education: Quality means effective teaching, relevant curriculum, and measurable outcomes.

6. Quality control
• Procedure or set of procedures intended to ensure that a manufactured product or
performed service adheres to a defined set of quality criteria or meets the
requirements of the client or customer
• It is a systematic process used by businesses to ensure their products or services
meet specific quality standards
• Involves monitoring, inspecting, and testing at various stages to identify and
address defects or deviations from established criteria.
• Goal is to maintain consistent quality, reduce defects, and improve customer
satisfaction
• It can also be said as an operational techniques and activities used to fulfill quality
requirements which involves detecting and correcting defects in finished products
or during the production process.

7. Characteristics of Quality Control
• Reactive Process: It is the process to find and fix the flaws in the
completed product, with focus on finding problems rather than solving
them.
• Defect Identification: With testing and inspection, the goal is to find
the defect as early as possible..
• Product-oriented: It entails examining, evaluating, and verifying the
product to make sure it satisfies the required standards of quality

8. Elements of Quality Control
• Standards and Specifications: Set benchmarks (e.g., pharmacopeial
standards like USP, BP)
• Inspection and Testing: Regular examination of raw materials, in-process
materials, and final products using physical, chemical, and microbiological
methods.
• Documentation: All QC activities are documented for traceability and
regulatory compliance
• Analytical Tools: Use of instruments (e.g., UV spectrophotometer, HPLC) for
precise measurement and validation
• Corrective Actions: If deviations or defects are found, actions are taken to
correct and prevent recurrence

9. Quality Assurance
• Quality Assurance is defined as an activity that ensures the approaches,
techniques, methods, and processes designed for the projects are implemented
correctly. It recognizes defects in the process. Quality Assurance is completed
before Quality Control
• QA is a wide ranging ranging concept covering all matters that individually or
collectively influence the quality of a product (WHO)
• The areas in pharmaceutical are Development, QC, Production, Distribution
and Inspection
• ISO 9000 defines as “part of quality management focussed on providing
confidence that quality requirements will be fulfilled

10. Characterstics
• Focuses on preventing defects
• Proactive process and is preventive in nature
• Helps to recognize flaws in the process
• These activities monitor and verify that the processes used
to manage and create deliverables have been followed

11. Characteristics of Quality Assurance
• Process-Oriented: To guarantee constant product quality, it places a
strong emphasis on the creation and application of reliable procedures
and standards.
• Proactive Process: Quality Assurance (QA) tries to prevent errors by
enhancing procedures, guaranteeing that quality is integrated into the
product from the start.
• Continuous Improvement: To improve quality over time, QA
includes constant process assessment and improvement

12. What is the difference QA and QC?
• Quality Assurance (QA) focuses on preventing defects and
maintaining the overall quality management system
• It ensures that proper processes are in place to avoid issues
• On the other hand, Quality Control (QC) involves detecting and
correcting defects through inspections and testing.
• QC ensures that products or services meet specific quality standards.
While QA is proactive, emphasizing prevention, QC is reactive,
emphasizing identification and correction of issues after they occur.

13. Difference in QC & QA
Aspect Quality Control (QC) Quality Assurance (QA)
Focus Product-oriented Process-oriented
Purpose Identify defects Prevent defects
Timing After production
Before and during
production
Activities
Testing, inspection,
sampling
SOP development, audits,
training