FACE REALITY ACTUAL TEST QUESTIONS
WITH COMPLETE ANSWER KEY
●● training
Answer: employees must have the education and expertise/experience to
perform their assigned roles
●● documentation and recordkeeping
Answer: provides an "easy to follow" trail for for product, its
component, equipment, materials, and process/procedures at any time
●● written procedures
Answer: 24 different types of document and records are required by
cgmp
●● control and identification of materials
Answer: knowledge of the receipt, origin, identity, status, location,
storage, and distribution of materials. all container contents must be
identified ie trash can
●● communication
Answer: written procedures are an especially important part- form basis
of good communication. crucial + required by cgmp to notify personnel
, of changes to procedures, practices, processes, specifications, and
equipment function.
●● label controls
Answer: the numerous regulations that require frequent inspection and
accountability of labels, labeling equipment, label operations, label
issuance, and label use.
●● contamination control
Answer: the requirements put in place to assure quality, purity, and
safety of product.
●● change control
Answer: any deviations, labratory investigations, or results that are out-
of-specification must be investigated and fully documented. if needed,
corrective actions (punishment d:) should be implemented.
●● maintenance and calibration
Answer: processes can only be controlled by equipment that is properly
maintained and functioning.
●● validation
Answer: provides documented evidence that a process does what it is
supposed to.
WITH COMPLETE ANSWER KEY
●● training
Answer: employees must have the education and expertise/experience to
perform their assigned roles
●● documentation and recordkeeping
Answer: provides an "easy to follow" trail for for product, its
component, equipment, materials, and process/procedures at any time
●● written procedures
Answer: 24 different types of document and records are required by
cgmp
●● control and identification of materials
Answer: knowledge of the receipt, origin, identity, status, location,
storage, and distribution of materials. all container contents must be
identified ie trash can
●● communication
Answer: written procedures are an especially important part- form basis
of good communication. crucial + required by cgmp to notify personnel
, of changes to procedures, practices, processes, specifications, and
equipment function.
●● label controls
Answer: the numerous regulations that require frequent inspection and
accountability of labels, labeling equipment, label operations, label
issuance, and label use.
●● contamination control
Answer: the requirements put in place to assure quality, purity, and
safety of product.
●● change control
Answer: any deviations, labratory investigations, or results that are out-
of-specification must be investigated and fully documented. if needed,
corrective actions (punishment d:) should be implemented.
●● maintenance and calibration
Answer: processes can only be controlled by equipment that is properly
maintained and functioning.
●● validation
Answer: provides documented evidence that a process does what it is
supposed to.
