INDUSTRIAL PHARMACY
Sairaj kumbhar
2MARKS :
1. What is master formula records?
➢ These are documents that provide a detailed description of a specific
formulation, including ingredients, quantities, and processing
instructions.
2. Write the principles of quality risk management.
➢ Identification of potential risks
➢ Assessment of risks
➢ Mitigation or control of risks
➢ Communication of risks
3. Enumerate the objectives of TIFAC.
➢ To assess technology trends at the national and international levels.
➢ To develop technology perspectives and identify areas for technology
forecasting and assessment.
4. Name the different types of drug applications that can be submitted to FDA.
➢ New Drug Application (NDA)
➢ Abbreviated New Drug Application (ANDA)
➢ Biologics License Application (BLA)
➢ Investigational New Drug (IND) Application
➢ Drug Master File (DMF)
5. What are the objectives of ICH guidelines?
➢ To ensure the safety, quality, and efficacy of medicinal products.
➢ To promote international cooperation and reduce duplication in the
development of new medicines.
6. What are the benefits of ISO 9000?
➢ Improved consistency in product quality
➢ Enhanced customer satisfaction
➢ Increased efficiency in processes
➢ Improved decision-making processes
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7. List out the significance of NABL accreditation
➢ Ensures that laboratories comply with international standards
➢ Enhances the credibility and reliability of test results
➢ Facilitates acceptance of test reports across borders
8. Define medical device. Give two examples.
➢ Medical devices are instruments, apparatuses, machines, implants, or
similar items used to diagnose, prevent, or treat diseases.
➢ Examples include syringes, MRI machines, pacemakers, and surgical
instruments.
9. Give two applications of biostatistics in pharmaceutical product
development.
➢ Determining sample sizes for clinical trials
➢ Analyzing and interpreting data from clinical trials
10. How equipment’s are categorized as per SUPAC guideline.
➢ SUPAC (Scale-Up and Post-Approval Changes) categorizes equipment
based on its impact on product quality and process performance into
major, moderate, or minor changes.
11. What are the significance pilot plant?
➢ Allows for testing of processes and formulations on a smaller scale before
full-scale production
➢ Helps in identifying and addressing potential issues or challenges early in
the development process
12. Differentiate qualification and calibration of equipment.
➢ Qualification ensures that equipment is suitable for its intended purpose
and is operating correctly.
➢ Calibration involves comparing measurements from an instrument to a
known standard to ensure accuracy.
13. Write the primary functions of APCTD.
➢ To facilitate technology development and commercialization
➢ To provide technical support and expertise to entrepreneurs and
industries
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14. What is the purpose of confidential agreement?
➢ To protect sensitive information from being disclosed to unauthorized
parties
➢ To establish the terms and conditions for sharing confidential information
between parties
15. What are the advantages of implementing TQM.
➢ Improved product quality and customer satisfaction
➢ Enhanced employee morale and engagement
➢ Increased efficiency and reduced costs
16. Mention the advantages of QbD.
➢ Enhanced process understanding and control
➢ Improved product quality and consistency
➢ Reduced risk of product failures and recalls
17. Define clinical trials and write its importance.
➢ Clinical trials are research studies that test how well new medical
treatments or interventions work in people.
➢ They are essential for evaluating the safety and efficacy of new drugs and
medical devices before they are approved for use by the general public.
18. Define biostatistics.
➢ Biostatistics is the application of statistical methods to biological and
health sciences. It involves the design and analysis of experiments and
studies to understand and interpret data.
19. What are the objectives of OOS.
➢ Objectives of Out-of-Specification (OOS) Investigations:
➢ To identify and correct any potential problems in the manufacturing
process
➢ To ensure the safety, efficacy, and quality of pharmaceutical products
20. Name the technology transfer agencies in India.
➢ National Research Development Corporation (NRDC)
➢ Biotechnology Industry Research Assistance Council (BIRAC)
21. Enlist the significances of batch formula record.
➢ Provides a detailed record of the formulation, ingredients, and processing
instructions for a specific batch
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➢ Ensures consistency and reproducibility of the batch manufacturing
process
22. How equipment are categorized as per SUPAC guideline
➢ As per SUPAC, equipment can be categorized based on its impact on
product quality and process performance into major, moderate, or minor
changes.
23. Write the two importance of Technology Transfer in Pharmaceutical
Industry.
➢ Facilitates the commercialization of new technologies and products
➢ Helps in improving competitiveness and expanding market reach
24. Write the primary objectives NRDC.
➢ To promote, develop, and commercialize indigenous technologies and
inventions
➢ To facilitate technology transfer and collaboration between industries,
R&D institutions, and academia
25. Write two key elements in managing clinical programs.
➢ Planning and coordination of clinical trials
➢ Monitoring and ensuring compliance with regulatory requirements
26. Write the significance BE study.
➢ BE studies are conducted to demonstrate that a generic product is
pharmaceutically equivalent and bioequivalent to a reference product.
➢ They are essential for ensuring the safety and efficacy of generic drugs.
27. What is zero-defect product?
➢ A zero-defect product is a product that meets all specifications and
requirements without any defects or deviations.
28. What are the objectives of GLP.
➢ To ensure the quality, integrity, and reliability of non-clinical laboratory
studies
➢ To promote the development of new drugs and chemicals by providing a
framework for data management and reporting
29. Two functions of Port Offices of CDSCO
➢ Facilitate the import and export of drugs and cosmetics
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➢ Conduct inspections and ensure compliance with regulatory
requirements
30. Write the types of drugs for which COPPs may be issued.
➢ Pharmaceutical products for human use
➢ Pharmaceutical products for veterinary use
31. What are the different parts of batch manufacturing record?
➢ Master formula
➢ Manufacturing instructions
➢ Packaging instructions
➢ Batch packaging record
32. What is platform technology?
➢ Platform technology refers to a set of techniques, methods, or processes
that can be applied to develop a range of products or technologies.
33. Write the two reasons for technology transfer in Pharmaceutical Industry.
➢ To access new markets and expand market reach
➢ To leverage expertise and capabilities of other organizations
34. Write the functions of BCIL.
➢ Functions of Biotechnology Consortium India Limited (BCIL):
➢ To promote, facilitate, and support biotechnology research and
commercialization in India
➢ To facilitate technology transfer and collaboration between academia,
industry, and government
35. List out various Regulatory Authorities.
➢ FDA (Food and Drug Administration) in the United States
➢ EMA (European Medicines Agency) in Europe
➢ CDSCO (Central Drugs Standard Control Organization) in India
36. Name the two key elements in managing clinical programs.
➢ Planning and coordination of clinical trials
➢ Monitoring and ensuring compliance with regulatory requirements
37. Write the four reasons for disqualification of testing facilities.
➢ Non-compliance with regulatory requirements
➢ Lack of quality management systems
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38. Classify Changes and give examples.
➢ Major changes: Changes that may affect product quality and require
regulatory approval (e.g., change in manufacturing process)
➢ Minor changes: Changes that are unlikely to affect product quality and
may not require regulatory approval (e.g., change in packaging)
39. What is CTD.
➢ Definition of Common Technical Document (CTD):
➢ CTD is a set of documents that provides a common format for the
submission of information to regulatory authorities for the registration of
pharmaceutical products.
40. Difference between assignable and non-assignable causes as per OOS.
➢ Difference between Assignable and Non-Assignable Causes as per Out-
of-Specification (OOS):
➢ Assignable causes are specific and can be identified and corrected (e.g.,
equipment malfunction)
➢ Non-assignable causes are inherent in the process and may require
process improvement (e.g., variation in raw materials)
41. Significance of Raw material requirements.
➢ Ensures that raw materials used in the manufacturing process meet
quality and safety standards
➢ Helps in maintaining consistency and quality of finished products
42. Write the benefits of pilot plant scale up studies
➢ Allows for optimization of processes and formulations
➢ Helps in predicting and addressing potential issues in full-scale
production
43. Write the two reasons for technology transfer in Pharmaceutical Industry.
➢ To access new technologies and expertise that may not be available in-
house
➢ To leverage existing infrastructure and capabilities of other organizations
44. Write the two functions of TIFAC.
➢ Functions of Technology Information, Forecasting and Assessment
Council (TIFAC):
➢ To assess technology trends and forecasts at national and international
levels
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➢ To promote technology development and commercialization in various
sectors
45. Name the two significance of New Drug Application (NDA).
➢ Provides a pathway for the approval of new drugs by regulatory authorities
➢ Ensures that new drugs are safe, effective, and of high quality
46. List the two key responsibilities of Regulatory Affairs.
➢ Ensuring compliance with regulatory requirements and guidelines
➢ Facilitating the approval and registration of pharmaceutical products
47. What are the elements of QbD.
➢ Define objectives
➢ Design and develop processes
➢ Understand and control sources of variability
➢ Establish a control strategy
➢ Continuously improve processes.
48. Classify Changes and give examples.
➢ Major changes: Changes that may affect product quality and require
regulatory approval (e.g., change in manufacturing process)
➢ Moderate changes: Changes that may have a moderate impact on
product quality and may require regulatory notification (e.g., change in
equipment)
➢ Minor changes: Changes that are unlikely to affect product quality and
may not require regulatory approval (e.g., change in packaging)
49. What are the significances of CTD?
➢ Significances of Common Technical Document (CTD):
➢ Provides a standardized format for submitting information to regulatory
authorities
➢ Facilitates the review and assessment of pharmaceutical products for
registration purposes
50. What are the Types of COPP.
➢ Certificate of Pharmaceutical Product (COPP):
➢ COPP for Export
➢ COPP for Sale in India
51. Name the contents of batch manufacturing record.
➢ Master formula
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➢ Manufacturing instructions
➢ Packaging instructions
➢ Batch packaging record
52. Name any four general requirements for pilot plant construction
➢ Compliance with Good Manufacturing Practices (GMP)
➢ Adequate space and facilities for process equipment
➢ Proper ventilation and environmental controls
➢ Safety measures and emergency procedures
53. What are the Steps involved technology transfer
➢ Planning and evaluation
➢ Technology assessment
➢ Technology transfer agreement
➢ Implementation and training
➢ Monitoring and review
54. Write features of TBSE.
➢ Features of Technology-Based Stakeholder Engagement (TBSE):
➢ Use of technology to engage stakeholders in decision-making processes
➢ Facilitates communication and collaboration among stakeholders
55. Write the two significances of BE Study.
➢ Significances of Bioequivalence (BE) Study:
➢ Ensures that generic drugs are therapeutically equivalent to the reference
product
➢ Helps in determining the safety and efficacy of generic drugs
56. What is ADR reporting
➢ ADR reporting is the process of collecting and monitoring information
about adverse reactions to medications.
➢ It helps in identifying and managing the risks associated with
medications.
57. Define TQM? What are the key elements”of TQM.
➢ TQM is a management approach aimed at continuous improvement of
quality in all aspects of an organization’s operations.
➢ Key elements of TQM include customer focus, process improvement, and
employee involvement.
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58. Enlist the benefits of ISO 14000.
➢ Helps organizations improve their environmental performance
➢ Enhances credibility and reputation with stakeholders
➢ Facilitates compliance with environmental regulations
59. List out places of Zonal offices and Sub-zonal offices of CDSO.
➢ Zonal Offices: CDSCO has zonal offices in various regions of India, such
as Delhi, Mumbai, Kolkata, and Chennai, to oversee regulatory activities
in their respective zones.
➢ Sub-zonal Offices: These offices are located in other cities within each
zone to assist the zonal offices in regulatory activities.
60. What is the scope of COPP.
➢ COPP certifies that a pharmaceutical product meets the required quality
standards and is approved for sale in a particular country.
➢ It is used for export or sale of pharmaceutical products.
61. Write the benefits of pilot plant scale up studies
➢ Allows for optimization of processes and formulations
➢ Helps in predicting and addressing potential issues in full-scale
production
62. Name any four general requirements for pilot plant construction
➢ Compliance with Good Manufacturing Practices (GMP)
➢ Adequate space and facilities for process equipment
➢ Proper ventilation and environmental controls
➢ Safety measures and emergency procedures
63. Enlist the significances of batch formula record
➢ Provides a detailed record of the formulation, ingredients, and processing
instructions for a specific batch
➢ Ensures consistency and reproducibility of the batch manufacturing
process
64. Write the primary objectives of NRDC.
➢ To promote, develop, and commercialize indigenous technologies and
inventions
➢ To facilitate technology transfer and collaboration between industries,
R&D institutions, and academia
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65. Write the two reasons for technology transfer in Pharmaceutical Industry.
➢ To access new technologies and expertise that may not be available in-
house
➢ To leverage existing infrastructure and capabilities of other organizations
66. Define validation and qualification.
➢ Validation: Confirmation by examination and provision of objective
evidence that the particular requirements for a specific intended use are
fulfilled.
➢ Qualification: Action of proving that any equipment works correctly and
actually leads to the expected results.
67. Name types of studies involved in Pre-clinical Drug Development.
➢ Pharmacodynamics (PD) studies
➢ Pharmacokinetics (PK) studies
➢ Toxicology studies
68. Name the five ICH efficacy guidelines with number and title.
➢ E1: The extent of population exposure to assess clinical safety for drugs
intended for long-term treatment of non-life-threatening conditions
➢ E2: Clinical safety data management: Definitions and standards for
expedited reporting
➢ E3: Structure and content of clinical study reports
➢ E4: Dose-response information to support drug registration
➢ E5: Ethnic factors in the acceptability of foreign clinical data
69. What are the personnel requirements as per GLP.
➢ Qualified personnel to perform and supervise studies
➢ Training programs for personnel involved in studies
70. What is zero-defect product?
➢ A product that meets all specifications and requirements without any
defects or deviations.
71. Write the significance of personnel requirements.
➢ Ensures that studies are conducted by qualified personnel
➢ Ensures the integrity and reliability of study data
72. Write the guidelines for technology transfer (TT).
➢ Establish clear objectives and scope
➢ Identify key personnel and responsibilities
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➢ Document all stages of the transfer process
➢ Conduct training and provide support during implementation
➢ Monitor and evaluate the transfer process
73. Write the functions of clinical studies.
➢ Evaluate the safety and efficacy of new drugs or treatments
➢ Provide data for regulatory approval of new drugs or treatments
74. What is State licensing authority?
➢ An authority responsible for issuing licenses for the manufacture, sale,
and distribution of pharmaceutical products within a state or region.
75. What are the objectives of NRDC.
➢ To promote, develop, and commercialize indigenous technologies and
inventions
➢ To facilitate technology transfer and collaboration between industries,
R&D institutions, and academia
76. What are MoUs and legal issues?
➢ MoUs (Memorandums of Understanding) and Legal Issues:
➢ MoUs are agreements between two or more parties outlining mutually
agreed-upon terms and conditions.
➢ Legal issues may arise in the context of intellectual property rights,
confidentiality, liability, and dispute resolution.
77. Define qualification and validation.
➢ Qualification: Action of proving that any equipment works correctly and
actually leads to the expected results.
➢ Validation: Confirmation by examination and provision of objective
evidence that the particular requirements for a specific intended use are
fulfilled.
78. Discuss the Role of Regulatory affairs department.
➢ Ensuring compliance with regulatory requirements
➢ Facilitating the approval and registration of pharmaceutical products
79. What is six sigma concept and OOS.
➢ Six Sigma is a methodology aimed at improving processes by reducing
defects and variations.
➢ OOS refers to a situation where a product does not meet its
predetermined specifications.
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80. Salient features of ISO 9000.
➢ Customer focus
➢ Leadership
➢ Involvement of people
➢ Process approach
➢ System approach to management
➢ Continual improvement
➢ Factual approach to decision making
➢ Mutually beneficial supplier relationships
81. Elements of TQM.
➢ Customer focus
➢ Continuous improvement
➢ Employee involvement
➢ Process approach
➢ System approach to management
➢ Factual approach to decision making
➢ Mutually beneficial supplier relationships
82. Define clinical research protocol.
➢ A detailed plan that outlines the objectives, design, methodology,
statistical considerations, and organization of a clinical study.
83. What is innovation and collaboration?
➢ Innovation refers to the introduction of new ideas, methods, or products.
➢ Collaboration involves working together with others to achieve a common
goal.
84. Quality control in Technology transfer.
➢ Ensures that the transferred technology meets quality standards and
requirements
➢ Involves testing and monitoring of the technology during and after transfer
85. What is CMC and preclinical testing?
➢ CMC refers to the regulatory submission that includes information about
the chemistry, manufacturing, and controls of a pharmaceutical product.
➢ Preclinical testing involves testing the safety and efficacy of a drug in
animals before testing in humans.
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86. Prospective validation.
➢ Prospective validation is the process of establishing documented
evidence that a system or process will consistently produce results
meeting predetermined specifications.
87. Detection limit and Quantitation limit.
➢ Detection limit is the lowest concentration of an analyte that can be
reliably detected but not necessarily quantified.
➢ Quantitation limit is the lowest concentration of an analyte that can be
reliably measured and quantified with acceptable precision and
accuracy.
88. What is investigators brochure.
➢ A document that provides an overview of the investigational product,
including its composition, pharmacological properties, and potential
risks and benefits.
89. Write about similarity factors and its significance.
➢ Similarity factors are used to assess the similarity between two
dissolution profiles.
➢ They are important for comparing the performance of generic drugs with
their reference products.
90. Write the principles of total quality management.
➢ Customer focus
➢ Continuous improvement
➢ Employee involvement
➢ Process approach
➢ System approach to management
➢ Factual approach to decision making
➢ Mutually beneficial supplier relationships
91. Write the primary objectives of pilot plant.
➢ To test and optimize manufacturing processes
➢ To scale up production from laboratory scale to full production scale
92. Enlist the significances of batch formula record.
➢ Provides a detailed record of the formulation, ingredients, and processing
instructions for a specific batch
➢ Ensures consistency and reproducibility of the batch manufacturing
process
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93. Write two responsibilities the Receiving Unit in technology transfer
➢ Ensuring that the transferred technology meets the receiving unit’s
requirements
➢ Providing feedback to the transferring unit regarding the performance of
the technology
94. What are the legal issues in TT.
➢ Intellectual property rights
➢ Confidentiality agreements
➢ Liability and indemnity
➢ Dispute resolution
95. Write two functions of Drug Development Team.
➢ Designing and implementing preclinical and clinical studies
➢ Monitoring the progress of drug development activities
96. Define Bioavailability and bioequivalence.
➢ Bioavailability: The rate and extent to which the active ingredient or active
moiety is absorbed from a drug product and becomes available at the site
of action.
➢ Bioequivalence: The absence of a significant difference in the rate and
extent to which the active ingredient or active moiety in pharmaceutical
equivalents or pharmaceutical alternatives becomes available at the site
of drug action when administered at the same molar dose under similar
conditions in an appropriately designed study.
97. Write two objectives of GLP.
➢ Ensure that tests and studies in laboratories are reliable and of good
quality.
➢ Promote the proper development of new drugs and chemicals.
98. Define standard deviation.
➢ Standard deviation is a measure of the dispersion or variability of a set of
values. It quantifies the amount of variation or dispersion of a set of
values.
99. Write two advantages of the COPP scheme.
➢ Facilitates the export of pharmaceutical products by providing
certification of compliance with regulatory requirements
➢ Helps in expediting the regulatory approval process in importing countries
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100. Write two functions of State Drug Regulatory Authorities (SDRAs)
➢ Licensing of pharmaceutical manufacturers, wholesalers, and retailers
➢ Monitoring and enforcement of compliance with drug laws and
regulations
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