JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD B. Pharmacy III PHARMACEUTICAL QUALITY ASSURANCE Previous Question Paper (November/December - 2020 - R17)
Answer any five questions. All questions carry equal marks.
Main
Differentiate QA and QC with respect to goal, focus, work flow and type of tool.
Answer
| Feature | Quality Assurance (QA) | Quality Control (QC) |
|---|---|---|
| Goal | To prevent defects by focusing on the process. | To identify and correct defects by focusing on the product. |
| Focus | Process-oriented; proactive approach. | Product-oriented; reactive approach. |
| Work Flow | Establishes guidelines and standards for production. | Tests the final product against established standards. |
| Type of Tool | Managerial and statistical tools (e.g., SOPs, audits, training). | Analytical and physical tools (e.g., testing, inspection, lab equipment). |
Explain the eight key elements of TQM in brief.
Answer
- Customer-focused: The customer ultimately determines the level of quality; all efforts are directed toward meeting or exceeding their requirements.
- Total employee involvement: All employees participate in working toward common goals, fostering empowerment and accountability.
- Process-centered: Focuses on the fundamental part of TQM, which is the definition and analysis of processes to ensure consistent output.
- Integrated system: Connects all business functions into a holistic model, ensuring that all departments work in synergy.
- Strategic and systematic approach: Incorporates a strategic plan that integrates quality as a core component of the organization's vision and mission.
- Continual improvement: Employs analytical and creative tools to find ways to become more competitive and effective at meeting stakeholder expectations.
- Fact-based decision making: Decisions are based on data and performance metrics rather than intuition, ensuring accuracy and objectivity.
- Communications: Effective communication strategies are essential to maintain morale and motivate employees at all levels during the implementation of quality initiatives.
Explain the role of QbD in a pharmaceutical industry.
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List the important elements of ISO 9000.
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Draw a layout of parenteral and liquid oral dosage plant in a pharmaceutical industry.
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Write the guidelines as per the Schedule M of D & C Rules, 1945 with respect to personnel.
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Write the few important responsibilities of Quality Control unit of a pharma plant.
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Classify types of glass containers used in pharmaceutical industry with their composition.
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Which information to be included in non-clinical final study report?
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Write the purpose and grounds for disqualification of testing facilities.
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List the contents of Master Formula Record.
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What is quality audit? Explain the types of quality audits in brief.
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Explain the purpose of material management in stores.
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List the general steps to be followed during analytical method validation.
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