B Pharmacy 6th Semester Pharmaceutical Quality Assurance Important Question Answer
B.Pharma 6th Semester Pharmaceutical Quality Assurance Important Question Answer
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| B Pharmacy 6th Semester Pharmaceutical Quality Assurance |
Pharmaceutical Quality Assurance Very Short Question Answer [2 Marks]
1. Define quality control:
Quality control is the part of GMP concerned with testing, sampling, and specifications to ensure that materials and final products meet quality standards before release.
2. Validation:
Validation is a documented process to prove that any procedure, process, equipment, or activity will consistently lead to expected results.
3. Define quality assurance:
Quality assurance is a comprehensive system of planned activities ensuring that products consistently meet quality standards.
4. Calibration:
Calibration is adjusting and checking instruments against known standards to ensure accuracy in measurements.
5. Types of validation:
Types include process validation, cleaning validation, analytical method validation, equipment validation, prospective, concurrent, and retrospective validation.
6. Master formula record:
A master formula record is a document detailing the complete manufacturing procedure, equipment, ingredients, and specifications for product batches.
7. Specification:
Specifications are defined standards for raw materials, intermediates, and finished products to ensure identity, strength, quality, and purity.
8. Standard operating procedure (SOP):
SOP is a documented set of step-by-step instructions to perform routine operations consistently and safely.
9. Audit:
Audit is a structured review of manufacturing or quality systems to ensure compliance with regulatory requirements.
10. Quality by design (QbD):
QbD is a scientific approach to pharmaceutical development that focuses on designing quality into products from the beginning.
11. Q-series guidelines:
These are ICH guidelines focused on quality aspects such as stability (Q1), validation (Q2), and pharmaceutical development (Q8).
12. QSEM:
QSEM is the classification of ICH guidelines into four categories: Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M).
13. Validation master plan:
It is a high-level document that outlines the validation strategy, including responsibilities, timelines, and scope of validation activities.
14. Master formula record:
It is a master document containing instructions for producing a batch, including quantities, equipment, and processing methods.
15. Distribution record:
It documents the batch-wise distribution of finished products, tracking movement to ensure recall, if needed.
16. Plant layout:
Plant layout is the physical arrangement of facilities and equipment to optimize workflow, safety, and contamination control.
17. Recalling and waste disposal:
Recalling is withdrawing unsafe products from the market. Waste disposal involves safe elimination of expired or unusable pharmaceutical materials.
18. Maintenance of sterile area:
Involves regular cleaning, HEPA filters, airlocks, pressure differentials, and restricted entry to ensure asepsis.
19. Quality audit:
A quality audit is a formal examination of quality systems and records to verify compliance with quality standards.
20. NABL accreditation:
NABL provides formal recognition to labs for technical competence under ISO/IEC 17025 for testing and calibration.
21. Define QC according to WHO:
WHO defines QC as procedures involving sampling, testing, and documentation to ensure materials are of appropriate quality before release.
22. Define good laboratory practice (GLP):
GLP refers to a set of principles intended to assure the quality and integrity of non-clinical laboratory studies.
23. Differentiate between QC and QA:
QC detects product defects via testing. QA ensures process and system quality to prevent defects from occurring.
24. What is validation protocol?:
A validation protocol is a detailed, written plan that outlines the process, methods, acceptance criteria, and responsibilities for validation.
25. Different contamination sources in pharma industry:
Sources include personnel, raw materials, air, water, equipment, surfaces, and cross-contamination.
26. Enlist the eight key elements of TQM:
Customer focus
Leadership
Employee involvement
Process approach
System approach
Continuous improvement
Fact-based decision making
Communication
27. Explain the following terms:
ICH: International Council for Harmonisation.
ISO: International Organization for Standardization.
SOP: Documented instructions for routine tasks.
TQM: Management approach for long-term success through customer satisfaction.
28. What is environmental management system?:
A system used to manage an organization’s environmental programs in a comprehensive, systematic, and sustainable manner.
29. What are batch formula and master formula?:
Batch formula refers to instructions for a single batch. Master formula is the standard set of instructions used for all batches.
30. Define complaint and recall:
Complaint: Notification of product defect.
Recall: Market withdrawal of a product that fails to meet quality standards.
31. Expand the following terms:
i) QBD – Quality by Design
ii) SOP – Standard Operating Procedure
iii) BMR – Batch Manufacturing Record
iv) GMP – Good Manufacturing Practices
32. Define quality assurance:
QA is a proactive system ensuring that every step of manufacturing contributes to a high-quality final product.
33. Differentiate calibration and qualification:
Calibration ensures instrument accuracy; qualification ensures equipment performs as intended under defined conditions.
34. Name any four types of dosages:
Tablets, capsules, injectables, ointments.
35. Define quality audits:
A quality audit is a documented process that evaluates quality management systems for compliance and effectiveness.
36. Define OOSM:
Out-of-Specification Material: Any material that fails to meet its predefined specifications.
37. Waste Disposal:
The safe and regulatory-compliant removal of pharmaceutical waste to avoid contamination and environmental harm.
38. What is contamination?:
It is the unintended presence of impurities or harmful microorganisms in materials or finished products.
39. Importance of batch formula record:
It ensures product consistency, traceability, GMP compliance, and helps in troubleshooting quality issues.
40. Define accuracy and precision:
Accuracy: Closeness to actual value.
Precision: Repeatability of results.
41. Explain the following terms:
i) GMP – Guidelines for safe and effective drug manufacturing.
ii) QBD – Scientific product development strategy.
iii) NABL – Accreditation body for labs.
iv) TQM – Holistic approach to continuous quality improvement.
42. Major differences between QC and QA:
QC focuses on product testing, while QA focuses on process control and prevention of defects.
43. Name GMP guidelines from WHO, MHRA, USFDA:
WHO GMP, MHRA GMP (UK), USFDA cGMP (21 CFR Part 210 & 211).
44. Different zones in India (climatic):
India belongs to Zone IVB – hot and humid climatic zone for stability studies.
45. Define validation:
Validation proves that processes and systems consistently produce results meeting quality requirements.
46. What is stability? Time period for studies?:
Stability is a drug's ability to maintain its quality over time.
Long-term: 12 months at 25°C/60% RH
Accelerated: 6 months at 40°C/75% RH
47. Advantages of warehousing:
Protection of goods, inventory control, quick distribution, minimized risk of damage or spoilage.
48. Expand the following:
i) NABL – National Accreditation Board for Testing and Calibration Laboratories
ii) ICH – International Council for Harmonisation
iii) SOP – Standard Operating Procedure
49. Define accuracy and precision:
Accuracy: Closeness to true value.
Precision: Reproducibility of repeated measurements.
50. What are batch formula and master formula?:
Batch formula is used for specific batch production.
Master formula is the standard guideline for all batches.
51. Define quality assurance:
QA is the systematic monitoring of all production aspects to ensure consistent product quality.
52. Elements of QBD program:
Target Product Profile, Critical Quality Attributes (CQAs), Risk Assessment, Design Space, Control Strategy, Lifecycle Management.
53. What are standard control articles?:
Reference standards or substances used in testing for comparison and validation of results.
54. Significance of batch formula record:
Ensures correct raw material use, proper procedures, traceability, and compliance with quality standards.
55. What is NABL accreditation?:
It is official recognition of a lab’s technical competence and compliance with ISO/IEC 17025.
56. Quality control tests for containers:
Light transmission
Water vapor permeability
Chemical resistance
Alkali content test
57. Different sources of contamination:
Personnel, air, equipment, raw materials, environment, and cross-contamination.
58. Purpose of ICH guidelines:
To harmonize technical and regulatory standards for drug development and approval globally.
59. Define calibration and validation:
Calibration: Ensuring equipment reads correctly.
Validation: Proving a process consistently meets specifications.
60. Quality control:
QC ensures the product's identity, strength, and purity through sampling and testing throughout manufacturing.
61. GMP (Good Manufacturing Practice):
GMP includes guidelines to ensure consistent production and control according to quality standards.
62. TQM (Total Quality Management):
TQM is a company-wide strategy for improving product and service quality through continuous feedback and involvement.
63. QBD (Quality by Design):
QBD is a product development model emphasizing process understanding, risk management, and lifecycle control.
64. Quality assurance:
QA includes all planned and systematic activities to ensure that products meet quality standards.
65. Benefits of ISO 9000:
Standardization, improved process efficiency, increased customer trust, better documentation, and global recognition.
66. Principle of NABL accreditation:
Assures that a lab is technically competent and provides reliable, accurate test/calibration data.
67. Elements of TQM:
Customer focus, leadership, employee involvement, process approach, system integration, continual improvement, factual decisions, communication.
68. Quality management concept:
A strategic approach involving quality planning, assurance, control, and improvement across all organizational processes.
69. Calibration:
Calibration ensures instruments are functioning accurately by comparing with known standards.
B.Pharmacy 6th Semester All Subject Important Short Question Answer
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