IgCP® Certification Exam –
2026/2027 Edition – Practice
Questions with Verified Answers
The IgCP® (Ig Certified Pharmacist) credential, administered by the
Immunoglobulin National Society (IgNS), is the only nationally
recognized certification for pharmacists managing immunoglobulin
(Ig) therapy. The exam consists of 100 questions to be completed
within a 2-hour time limit, with testing windows offered four times per
year.
The following practice questions are organized by the five main
content domains outlined in the IgCP Candidate Handbook, covering
formulation, pathophysiology, patient management, safety, and
professional practice.
DOMAIN 1: Formulation and Manufacturing of Ig
Therapy (~20%)
1. What is the primary mechanism of action of intravenous
immunoglobulin (IVIG)?
A) Direct cytotoxicity
B) Complement activation
C) Passive immunization and immunomodulation
D) Enzyme inhibition
,Answer: C) Passive immunization and immunomodulation
Rationale: IVIG provides passive immunity through antibody
replacement and also exerts immunomodulatory effects, including Fc
receptor blockade and inhibition of complement activation. The
combination of these mechanisms makes it effective for both
replacement and immunomodulatory indications.
2. What is the primary source of plasma for IVIG production?
A) Individual donors
B) Pooled plasma from thousands of donors
C) Synthetic production
D) Animal plasma
Answer: B) Pooled plasma from thousands of donors
Rationale: IVIG is manufactured from pooled human plasma collected
from thousands of screened donors. This pooling ensures a broad
spectrum of antibodies and dilutes any potentially harmful antibodies
from individual donors, enhancing both efficacy and safety.
3. What is the typical protein concentration of standard IVIG
preparations?
A) 2.5%
B) 5%
C) 10%
D) 20%
Answer: C) 10%
, Rationale: Standard IVIG preparations typically contain 10% protein (100
mg/mL). Some products are available as 5% solutions (50 mg/mL),
which require larger infusion volumes for equivalent dosing.
Concentrated formulations allow for reduced infusion time and volume.
4. Which viral inactivation method is commonly used in IVIG
manufacturing?
A) Heat treatment only
B) Solvent/detergent treatment only
C) Multiple methods including heat, solvent/detergent, and filtration
D) UV irradiation only
Answer: C) Multiple methods including heat, solvent/detergent, and
filtration
Rationale: Multiple viral inactivation and removal methods are used to
ensure patient safety. This multi-step safety cascade includes plasma
screening, fractionation, solvent/detergent treatment (which inactivates
enveloped viruses), nanofiltration, and pasteurization (heat treatment).
5. What is the primary role of solvent/detergent (S/D) treatment in
immunoglobulin manufacturing?
A) To aggregate IgG molecules for higher concentration
B) To inactivate enveloped viruses, such as HIV and Hepatitis B
C) To remove non-enveloped viruses
D) To enhance the immunomodulatory properties
Answer: B) To inactivate enveloped viruses, such as HIV and Hepatitis
B
2026/2027 Edition – Practice
Questions with Verified Answers
The IgCP® (Ig Certified Pharmacist) credential, administered by the
Immunoglobulin National Society (IgNS), is the only nationally
recognized certification for pharmacists managing immunoglobulin
(Ig) therapy. The exam consists of 100 questions to be completed
within a 2-hour time limit, with testing windows offered four times per
year.
The following practice questions are organized by the five main
content domains outlined in the IgCP Candidate Handbook, covering
formulation, pathophysiology, patient management, safety, and
professional practice.
DOMAIN 1: Formulation and Manufacturing of Ig
Therapy (~20%)
1. What is the primary mechanism of action of intravenous
immunoglobulin (IVIG)?
A) Direct cytotoxicity
B) Complement activation
C) Passive immunization and immunomodulation
D) Enzyme inhibition
,Answer: C) Passive immunization and immunomodulation
Rationale: IVIG provides passive immunity through antibody
replacement and also exerts immunomodulatory effects, including Fc
receptor blockade and inhibition of complement activation. The
combination of these mechanisms makes it effective for both
replacement and immunomodulatory indications.
2. What is the primary source of plasma for IVIG production?
A) Individual donors
B) Pooled plasma from thousands of donors
C) Synthetic production
D) Animal plasma
Answer: B) Pooled plasma from thousands of donors
Rationale: IVIG is manufactured from pooled human plasma collected
from thousands of screened donors. This pooling ensures a broad
spectrum of antibodies and dilutes any potentially harmful antibodies
from individual donors, enhancing both efficacy and safety.
3. What is the typical protein concentration of standard IVIG
preparations?
A) 2.5%
B) 5%
C) 10%
D) 20%
Answer: C) 10%
, Rationale: Standard IVIG preparations typically contain 10% protein (100
mg/mL). Some products are available as 5% solutions (50 mg/mL),
which require larger infusion volumes for equivalent dosing.
Concentrated formulations allow for reduced infusion time and volume.
4. Which viral inactivation method is commonly used in IVIG
manufacturing?
A) Heat treatment only
B) Solvent/detergent treatment only
C) Multiple methods including heat, solvent/detergent, and filtration
D) UV irradiation only
Answer: C) Multiple methods including heat, solvent/detergent, and
filtration
Rationale: Multiple viral inactivation and removal methods are used to
ensure patient safety. This multi-step safety cascade includes plasma
screening, fractionation, solvent/detergent treatment (which inactivates
enveloped viruses), nanofiltration, and pasteurization (heat treatment).
5. What is the primary role of solvent/detergent (S/D) treatment in
immunoglobulin manufacturing?
A) To aggregate IgG molecules for higher concentration
B) To inactivate enveloped viruses, such as HIV and Hepatitis B
C) To remove non-enveloped viruses
D) To enhance the immunomodulatory properties
Answer: B) To inactivate enveloped viruses, such as HIV and Hepatitis
B
