Current Good Manufacturing Practices (cGMP)
and Process Validation in Pharma UPDATED
ACTUAL QUESTIONS AND CORRECT
ANSWERS
What does cGMP stand for? Current Good Manufacturing Practices
What is the purpose of process To assure that a specific process will consistently
validation? produce a product meeting its predetermined
specifications and quality attributes.
What must be validated before Facilities, utilities, equipment, computer control
proceeding with a process? systems, methods, and operators.
What does facility validation ensure? That buildings and processing rooms are designed,
built, and operated in an acceptable manner for
the operations being performed.
What is included in utility validation? Assuring that utilities such as compressed air,
nitrogen, water, vacuum, and sewers/drains are
designed, built, and operated properly.
What does equipment validation That equipment used to process materials is
ensure? sufficient for the operations being performed.
What is the role of computer To ensure that computer control systems are
validation? designed, built, and operated effectively to control
the process.
, What is method validation? The process of confirming that analytical methods
used to measure product attributes are accurate,
precise, and robust.
Why can't people be validated in the People do not provide consistent outputs; they are
same way as processes? trained and qualified based on experience,
education, and training.
What is the definition of process The collection and evaluation of data from the
validation? process design stage through commercial
production to establish that a process is capable of
consistently delivering quality products.
What are the three stages of process 1. Process design, 2. Process qualification, 3.
validation? Continued process verification.
and Process Validation in Pharma UPDATED
ACTUAL QUESTIONS AND CORRECT
ANSWERS
What does cGMP stand for? Current Good Manufacturing Practices
What is the purpose of process To assure that a specific process will consistently
validation? produce a product meeting its predetermined
specifications and quality attributes.
What must be validated before Facilities, utilities, equipment, computer control
proceeding with a process? systems, methods, and operators.
What does facility validation ensure? That buildings and processing rooms are designed,
built, and operated in an acceptable manner for
the operations being performed.
What is included in utility validation? Assuring that utilities such as compressed air,
nitrogen, water, vacuum, and sewers/drains are
designed, built, and operated properly.
What does equipment validation That equipment used to process materials is
ensure? sufficient for the operations being performed.
What is the role of computer To ensure that computer control systems are
validation? designed, built, and operated effectively to control
the process.
, What is method validation? The process of confirming that analytical methods
used to measure product attributes are accurate,
precise, and robust.
Why can't people be validated in the People do not provide consistent outputs; they are
same way as processes? trained and qualified based on experience,
education, and training.
What is the definition of process The collection and evaluation of data from the
validation? process design stage through commercial
production to establish that a process is capable of
consistently delivering quality products.
What are the three stages of process 1. Process design, 2. Process qualification, 3.
validation? Continued process verification.
