100 frequently asked questions and answers for qualified persons in Pharmaceutical industry

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1. What is the pharmaceutical industry?

The pharmaceutical industry refers to the sector involved in the research, development,
manufacturing, and distribution of drugs and medications for medical use.

2. What are the different types of pharmaceutical companies?

There are various types of pharmaceutical companies, including research-based pharmaceutical
companies, generic drug manufacturers, contract research organizations (CROs), biotechnology
companies, and specialty pharmaceutical companies.

3. What is the role of a qualified person (QP) in the pharmaceutical industry?

A qualified person is responsible for ensuring that medicinal products are manufactured and
distributed in compliance with regulatory requirements. They certify the release of batches of drugs
onto the market.

4. What qualifications are required to become a qualified person?

To become a qualified person, one typically needs a degree in pharmacy, chemistry, or a related field.
Additionally, extensive experience in the pharmaceutical industry and knowledge of regulatory
frameworks is necessary.

5. What is Good Manufacturing Practice (GMP)?

Good Manufacturing Practice (GMP) refers to the guidelines and regulations that ensure
pharmaceutical products are consistently produced and controlled according to quality standards.

6. What is Good Distribution Practice (GDP)?

Good Distribution Practice (GDP) ensures that medicinal products are stored, transported, and
distributed in a manner that maintains their quality and integrity.

7. What are the key regulatory bodies governing the pharmaceutical industry?
The key regulatory bodies governing the pharmaceutical industry include the Food and Drug
Administration (FDA) in the United States, the European Medicines Agency (EMA) in Europe, and the
World Health Organization (WHO) globally.

8. What is a Drug Master File (DMF)?

A Drug Master File (DMF) is a confidential document submitted to regulatory authorities that contains
detailed information about the manufacturing, processing, and components of a drug product.

9. What is a Certificate of Analysis (CoA)?

A Certificate of Analysis (CoA) is a document provided by a manufacturer that certifies the quality and
purity of a batch of pharmaceutical product.

10. What is a pharmacopoeia?

A pharmacopoeia is a book or set of standards that contains information about the quality, purity, and
strength of drugs and medications.
11. What is the difference between a brand-name drug and a generic drug?
A brand-name drug is a medication that is marketed under a specific brand name by the company that
developed it. A generic drug is a copy of the brand-name drug that contains the same active
ingredients and is usually sold at a lower price.

12. What is the Drug Approval Process?

The Drug Approval Process refers to the series of steps that a pharmaceutical product must go
through to gain regulatory approval for marketing and sale.

13. What is the role of clinical trials in drug development?

Clinical trials are conducted to evaluate the safety and efficacy of new drugs or treatments in humans
before they can be approved for use.

14. What are the different phases of clinical trials?

Clinical trials typically have four phases: Phase 1 (safety and dosage), Phase 2 (efficacy and side
effects), Phase 3 (large-scale effectiveness), and Phase 4 (post-marketing surveillance).

15. What is a placebo?

A placebo is an inactive substance or treatment given to participants in a clinical trial to compare the
effects of the investigational drug with those of no treatment.

16. What is Good Clinical Practice (GCP)?

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing,
conducting, recording, and reporting clinical trials.

17. What is a Pharmacovigilance System?

A Pharmacovigilance System is responsible for monitoring and collecting information about the
safety and side effects of medicinal products after they have been authorized for use.

18. What is a Risk Management Plan (RMP)?

A Risk Management Plan (RMP) outlines the measures taken to

identify, characterize, and minimize the risks associated with a medicinal product throughout its
lifecycle.

19. What is a Quality Management System (QMS)?

A Quality Management System (QMS) is a set of policies, processes, and procedures used to ensure
that products and services meet quality requirements.

20. What is Process Validation?

Process Validation is the documented evidence that a process consistently produces a result or
product meeting predetermined specifications.

21. What is a Standard Operating Procedure (SOP)?

A Standard Operating Procedure (SOP) is a detailed step-by-step guide that outlines the procedures to
be followed for specific tasks or processes.

22. What is the role of a Quality Assurance (QA) department in pharmaceutical manufacturing?
The Quality Assurance (QA) department is responsible for ensuring that all manufacturing processes
and procedures comply with regulatory requirements and quality standards.
23. What is the role of a Regulatory Affairs (RA) department in the pharmaceutical industry?
The Regulatory Affairs (RA) department is responsible for ensuring compliance with regulatory
requirements and managing interactions with regulatory authorities.

24. What is a Batch Record?

A Batch Record is a document that provides a complete history of a batch of pharmaceutical product,
including manufacturing, testing, packaging, and distribution information.

25. What is a Deviation?

A Deviation is an unplanned or unanticipated event or occurrence that deviates from established
procedures or specifications.

26. What is a Change Control System?

A Change Control System is a process used to manage and document changes to validated systems,
processes, or procedures to ensure they are implemented in a controlled manner.

27. What is an Out-of-Specification (OOS) result?

An Out-of-Specification (OOS) result refers to a test result that falls outside the predetermined
acceptance criteria or specifications.

28. What is a Corrective and Preventive Action (CAPA)?

A Corrective and Preventive Action (CAPA) is a systematic approach to investigate and address the
root cause of a non-conformance or deviation to prevent recurrence.

29. What is a Quality Risk Management (QRM) process?

A Quality Risk Management (QRM) process is a systematic approach to identifying, assessing, and
controlling risks to product quality, patient safety, and data integrity.

30. What is a Stability Study?

A Stability Study is conducted to evaluate the effect of environmental factors such as temperature,
humidity, and light on the quality and stability of a pharmaceutical product over time.

31. What is a Cleanroom?

A Cleanroom is a controlled environment with low levels of pollutants such as dust, airborne
microbes, and chemical vapors, used in pharmaceutical manufacturing to ensure product quality.

32. What is a Batch Release?

Batch Release refers to the process of reviewing and approving a batch of pharmaceutical product by
a qualified person before it can be released for distribution or sale.

33. What is a Recall?

A Recall is the process of removing or correcting marketed pharmaceutical products that are found to
be defective, potentially harmful, or in violation of regulatory requirements.

34. What is a Quality Agreement?

A Quality Agreement is a formal document that defines the responsibilities, processes, and
procedures related to quality between two parties involved in the supply chain, such as a
manufacturer and a contract testing laboratory.

35. What is Data Integrity?

Data Integrity refers to the completeness, accuracy, consistency, and reliability of data throughout its
lifecycle, including creation, processing, storage, and retrieval.
36. What is a Quality Risk Management (QRM) tool?
A Quality Risk Management (QRM) tool is a systematic approach or software used to assess and
manage risks related to product quality, patient safety, and data integrity.

37. What is a Pharmacokinetic Study?

A Pharmacokinetic Study evaluates how drugs are absorbed, distributed, metabolized, and excreted by
the body to determine their p

harmacokinetic properties.

38. What is a Pharmacodynamic Study?

A Pharmacodynamic Study evaluates the effects of drugs on the body, including their mechanism of
action, efficacy, and safety.

39. What is a Quality Control (QC) laboratory?

A Quality Control (QC) laboratory is responsible for testing and analyzing raw materials, in-process
samples, and finished products to ensure they meet quality specifications.

40. What is a Stability Chamber?

A Stability Chamber is an environmental chamber used to store pharmaceutical products under
controlled conditions of temperature and humidity to evaluate their stability over time.

41. What is a Process Analytical Technology (PAT)?

Process Analytical Technology (PAT) refers to the use of advanced analytical tools and techniques to
monitor and control manufacturing processes in real-time for improved product quality.

42. What is a Risk Assessment?

A Risk Assessment is a systematic process of identifying, evaluating, and prioritizing risks to
determine the best course of action for risk mitigation.

43. What is a Quality Audit?

A Quality Audit is an independent review or examination of processes, procedures, and systems to
ensure compliance with regulatory requirements and quality standards.

44. What is a Quality Agreement?

A Quality Agreement is a formal document that defines the responsibilities, processes, and
procedures related to quality between two parties involved in the supply chain, such as a
manufacturer and a contract testing laboratory.

45. What is a Change Control System?

A Change Control System is a process used to manage and document changes to validated systems,
processes, or procedures to ensure they are implemented in a controlled manner.

46. What is an Out-of-Specification (OOS) result?

An Out-of-Specification (OOS) result refers to a test result that falls outside the predetermined
acceptance criteria or specifications.

47. What is a Corrective and Preventive Action (CAPA)?

A Corrective and Preventive Action (CAPA) is a systematic approach to investigate and address the
root cause of a non-conformance or deviation to prevent recurrence.

48. What is a Quality Risk Management (QRM) process?

A Quality Risk Management (QRM) process is a systematic approach to identifying, assessing, and
controlling risks to product quality, patient safety, and data integrity.

49. What is a Stability Study?

A Stability Study is conducted to evaluate the effect of environmental factors such as temperature,
humidity, and light on the quality and stability of a pharmaceutical product over time.

50. What is a Cleanroom?

A Cleanroom is a controlled environment with low levels of pollutants such as dust, airborne
microbes, and chemical vapors, used in pharmaceutical manufacturing to ensure product quality.

51. What is a Batch Release?

Batch Release refers to the process of reviewing and approving a batch of pharmaceutical product by
a qualified person before it can be released for distribution or sale.

52. What is a Recall?

A Recall is the process of removing or correcting marketed pharmaceutical products that are found to
be defective, potentially harmful, or in violation of regulatory requirements.

53. What is a Quality Agreement?

A Quality Agreement is a formal document that defines the responsibilities, processes, and
procedures related to quality between two parties involved in the supply chain, such as a
manufacturer and a contract testing laboratory.

54. What is Data Integrity?

Data Integrity refers to the completeness, accuracy, consistency, and reliability of data throughout its
lifecycle, including creation, processing, storage, and retrieval.

55. What is a Quality Risk Management (QRM) tool?

A Quality Risk Management (QRM) tool is a systematic approach or software used to assess and
manage risks related to product quality, patient safety, and data integrity.

56. What is a Pharmacokinetic Study?

A Pharmacokinetic Study evaluates how drugs are absorbed, distributed, metabolized, and excreted by
the body to determine their pharmacokinetic properties.

57. What is a P

harmacodynamic Study?
A Pharmacodynamic Study evaluates the effects of drugs on the body, including their mechanism of
action, efficacy, and safety.

58. What is a Quality Control (QC) laboratory?

A Quality Control (QC) laboratory is responsible for testing and analyzing raw materials, in-process
samples, and finished products to ensure they meet quality specifications.

59. What is a Stability Chamber?

A Stability Chamber is an environmental chamber used to store pharmaceutical products under
controlled conditions of temperature and humidity to evaluate their stability over time.

60. What is a Process Analytical Technology (PAT)?

Process Analytical Technology (PAT) refers to the use of advanced analytical tools and techniques to
monitor and control manufacturing processes in real-time for improved product quality.
61. What is a Risk Assessment?
A Risk Assessment is a systematic process of identifying, evaluating, and prioritizing risks to
determine the best course of action for risk mitigation.

62. What is a Quality Audit?

A Quality Audit is an independent review or examination of processes, procedures, and systems to
ensure compliance with regulatory requirements and quality standards.

63. What is a Quality Management System (QMS)?

A Quality Management System (QMS) is a set of policies, processes, and procedures used to ensure
that products and services meet quality requirements.

64. What is Process Validation?

Process Validation is the documented evidence that a process consistently produces a result or
product meeting predetermined specifications.

65. What is a Standard Operating Procedure (SOP)?

A Standard Operating Procedure (SOP) is a detailed step-by-step guide that outlines the procedures to
be followed for specific tasks or processes.

66. What is the role of a Quality Assurance (QA) department in pharmaceutical manufacturing?
The Quality Assurance (QA) department is responsible for ensuring that all manufacturing processes
and procedures comply with regulatory requirements and quality standards.

67. What is the role of a Regulatory Affairs (RA) department in the pharmaceutical industry?
The Regulatory Affairs (RA) department is responsible for ensuring compliance with regulatory
requirements and managing interactions with regulatory authorities.

68. What is a Batch Record?

A Batch Record is a document that provides a complete history of a batch of pharmaceutical product,
including manufacturing, testing, packaging, and distribution information.

69. What is a Deviation?

A Deviation is an unplanned or unanticipated event or occurrence that deviates from established
procedures or specifications.

70. What is a Change Control System?

A Change Control System is a process used to manage and document changes to validated systems,
processes, or procedures to ensure they are implemented in a controlled manner.

71. What is an Out-of-Specification (OOS) result?

An Out-of-Specification (OOS) result refers to a test result that falls outside the predetermined
acceptance criteria or specifications.

72. What is a Corrective and Preventive Action (CAPA)?

A Corrective and Preventive Action (CAPA) is a systematic approach to investigate and address the
root cause of a non-conformance or deviation to prevent recurrence.

73. What is a Quality Risk Management (QRM) process?

A Quality Risk Management (QRM) process is a systematic approach to identifying, assessing, and
controlling risks to product quality, patient safety, and data integrity.
74. What is a Stability Study?
A Stability Study is conducted to evaluate the effect of environmental factors such as temperature,
humidity, and light on the quality and stability of a pharmaceutical product over time.

75. What is a Cleanroom?

A Cleanroom is a controlled environment with low levels of pollutants such as dust, airborne
microbes, and chemical vapors, used in pharmaceutical manufacturing to ensure product quality.

76. What is a Batch Release?

Batch Release refers to the process of reviewing and approving a batch of pharmaceutical product by
a qualified person before

it can be released for distribution or sale.

77. What is a Recall?

A Recall is the process of removing or correcting marketed pharmaceutical products that are found to
be defective, potentially harmful, or in violation of regulatory requirements.

78. What is a Quality Agreement?

A Quality Agreement is a formal document that defines the responsibilities, processes, and
procedures related to quality between two parties involved in the supply chain, such as a
manufacturer and a contract testing laboratory.

79. What is Data Integrity?

Data Integrity refers to the completeness, accuracy, consistency, and reliability of data throughout its
lifecycle, including creation, processing, storage, and retrieval.

80. What is a Quality Risk Management (QRM) tool?

A Quality Risk Management (QRM) tool is a systematic approach or software used to assess and
manage risks related to product quality, patient safety, and data integrity.

81. What is a Pharmacokinetic Study?

A Pharmacokinetic Study evaluates how drugs are absorbed, distributed, metabolized, and excreted by
the body to determine their pharmacokinetic properties.

82. What is a Pharmacodynamic Study?

A Pharmacodynamic Study evaluates the effects of drugs on the body, including their mechanism of
action, efficacy, and safety.

83. What is a Quality Control (QC) laboratory?

A Quality Control (QC) laboratory is responsible for testing and analyzing raw materials, in-process
samples, and finished products to ensure they meet quality specifications.

84. What is a Stability Chamber?

A Stability Chamber is an environmental chamber used to store pharmaceutical products under
controlled conditions of temperature and humidity to evaluate their stability over time.

85. What is a Process Analytical Technology (PAT)?

Process Analytical Technology (PAT) refers to the use of advanced analytical tools and techniques to
monitor and control manufacturing processes in real-time for improved product quality.

86. What is a Risk Assessment?

A Risk Assessment is a systematic process of identifying, evaluating, and prioritizing risks to
determine the best course of action for risk mitigation.

87. What is a Quality Audit?

A Quality Audit is an independent review or examination of processes, procedures, and systems to
ensure compliance with regulatory requirements and quality standards.

88. What is a Quality Management System (QMS)?

A Quality Management System (QMS) is a set of policies, processes, and procedures used to ensure
that products and services meet quality requirements.

89. What is Process Validation?

Process Validation is the documented evidence that a process consistently produces a result or
product meeting predetermined specifications.

90. What is a Standard Operating Procedure (SOP)?

A Standard Operating Procedure (SOP) is a detailed step-by-step guide that outlines the procedures to
be followed for specific tasks or processes.

91. What is the role of a Quality Assurance (QA) department in pharmaceutical manufacturing?
The Quality Assurance (QA) department is responsible for ensuring that all manufacturing processes
and procedures comply with regulatory requirements and quality standards.

92. What is the role of a Regulatory Affairs (RA) department in the pharmaceutical industry?
The Regulatory Affairs (RA) department is responsible for ensuring compliance with regulatory
requirements and managing interactions with regulatory authorities.

93. What is a Batch Record?

A Batch Record is a document that provides a complete history of a batch of pharmaceutical product,
including manufacturing, testing, packaging, and distribution information.

94. What is a Deviation?

A Deviation is an unplanned or unanticipated event or occurrence that deviates from established
procedures or specifications.

95. What is a Change Control System?

A Change Control System is a process used to manage and document changes to validated systems,
processes, or procedures to ensure they are implemented in a controlled manner.

96. What is an Out-of-Specification (OOS) result?

An Out-of-Specification (OOS

) result refers to a test result that falls outside the predetermined acceptance criteria or specifications.

97. What is a Corrective and Preventive Action (CAPA)?

A Corrective and Preventive Action (CAPA) is a systematic approach to investigate and address the
root cause of a non-conformance or deviation to prevent recurrence.

98. What is a Quality Risk Management (QRM) process?

A Quality Risk Management (QRM) process is a systematic approach to identifying, assessing, and
controlling risks to product quality, patient safety, and data integrity.

99. What is a Stability Study?

A Stability Study is conducted to evaluate the effect of environmental factors such as temperature,
humidity, and light on the quality and stability of a pharmaceutical product over time.

100. What is a Cleanroom?

A Cleanroom is a controlled environment with low levels of pollutants such as dust, airborne
microbes, and chemical vapors, used in pharmaceutical manufacturing to ensure product quality.