BACE EXAMS 2026 PREMIUM REVIEW
QUESTIONS CORRECT RESPONSES
◉ Standard Operating Procedures (SOPs). Answer: A controlled
document that contains detailed instructions for performing specific
tasks or processes. It provides consistent methods for carrying out
various operations, ensuring compliance within specifications.
◉ Standard Operating Procedures (SOPs). Answer: Quality
Assurance (QA) develops and oversees [these documents];
Production/Manufacturing uses [them] for manufacturing
processes, equipment operation, and material handling.
◉ Batch record. Answer: A controlled document that contains
documentation of complete history of a batch or lot of product,
including formulation, processing and packaging. Ensures
traceability and verification that production was carried out
according to documented procedures and specification.
◉ Batch record. Answer: Production/manufacturing completes [this
document] during manufacturing, ensuring all steps are
documented; Quality Assurance (QA) reviews [these documents] for
accuracy before approving batch for release
,◉ Quality Control (QC) Records. Answer: A controlled document
that contains records of testing and inspections conducted to ensure
product quality and compliance with specifications. Ensures that the
product remains within acceptable quality limits.
◉ Quality Control (QC) Records. Answer: Quality Control (QC)
maintains records of raw material testing, in-process testing, and
finished product testing in [this document].
◉ Deviation Reports. Answer: A controlled document that contains
documentation of any deviations from standard procedure. It helps
to identify root causes and implement fixes to deviation and
prevention of further deviations
◉ Deviation Reports. Answer: Production/manufacturing reports
deviations encountered manufacturing using [this document];
Quality Assurance (QA) reviews and investigates deviations,
implementing corrective and preventative actions.
◉ Change control documents. Answer: A controlled document that
contains records of changes made to processes, equipment, or
documentation, including the rationale, impact assessment, and
approval
,◉ Change control documents. Answer: Quality Assurance (QA)
manages change control processes and ensures that all changes are
documented and approved using [this document].
◉ Training records. Answer: A controlled document that contains
documentation of employee training on GMP procedures, processes,
and equipment use.
◉ Training records. Answer: Human Resources (HR) maintains
records of employee training and qualifications, and Quality
Assurance (QA) ensures that employees are trained and that training
records are up-to-date using [these documents]
◉ Equipment Maintenance Records. Answer: A controlled document
that contains documentation of maintenance, calibration, and
repairs of equipment used in manufacturing
◉ Equipment Maintenance Records. Answer: Facilities/Maintenance
maintains records of routine maintenance, repairs, and calibration
activities using [these documents]; Production/Manufacturing
provides input on equipment performance and any issues
encountered
◉ Validation Documents. Answer: A controlled document that
contains records related to the validation of processes, equipment,
and systems to ensure they meet predefined specifications.
, ◉ Validation Documents. Answer: Quality Assurance (QA) Oversees
validation activities and documentation with [these documents];
Engineering conducts and documents validation of equipment and
processes using [these documents]
◉ Regulatory Submissions and Correspondence. Answer: A
controlled document that contains documentation related to
submissions for product approvals, regulatory inspections, and
communication with regulatory agencies.
◉ Regulatory Submissions and Correspondence. Answer: Regulatory
Affairs prepares and submits regulatory documents and manages
correspondence with regulatory bodies.
◉ Environmental Monitoring Records. Answer: A controlled
document that contains records of environmental monitoring, such
as air quality, cleanliness, and temperature control within
manufacturing areas.
◉ Environmental Monitoring Records. Answer: Quality Control (QC)
monitors and documents environmental conditions using [these
documents]; Facilities ensures that environmental control systems
are functioning properly using [these documents]
QUESTIONS CORRECT RESPONSES
◉ Standard Operating Procedures (SOPs). Answer: A controlled
document that contains detailed instructions for performing specific
tasks or processes. It provides consistent methods for carrying out
various operations, ensuring compliance within specifications.
◉ Standard Operating Procedures (SOPs). Answer: Quality
Assurance (QA) develops and oversees [these documents];
Production/Manufacturing uses [them] for manufacturing
processes, equipment operation, and material handling.
◉ Batch record. Answer: A controlled document that contains
documentation of complete history of a batch or lot of product,
including formulation, processing and packaging. Ensures
traceability and verification that production was carried out
according to documented procedures and specification.
◉ Batch record. Answer: Production/manufacturing completes [this
document] during manufacturing, ensuring all steps are
documented; Quality Assurance (QA) reviews [these documents] for
accuracy before approving batch for release
,◉ Quality Control (QC) Records. Answer: A controlled document
that contains records of testing and inspections conducted to ensure
product quality and compliance with specifications. Ensures that the
product remains within acceptable quality limits.
◉ Quality Control (QC) Records. Answer: Quality Control (QC)
maintains records of raw material testing, in-process testing, and
finished product testing in [this document].
◉ Deviation Reports. Answer: A controlled document that contains
documentation of any deviations from standard procedure. It helps
to identify root causes and implement fixes to deviation and
prevention of further deviations
◉ Deviation Reports. Answer: Production/manufacturing reports
deviations encountered manufacturing using [this document];
Quality Assurance (QA) reviews and investigates deviations,
implementing corrective and preventative actions.
◉ Change control documents. Answer: A controlled document that
contains records of changes made to processes, equipment, or
documentation, including the rationale, impact assessment, and
approval
,◉ Change control documents. Answer: Quality Assurance (QA)
manages change control processes and ensures that all changes are
documented and approved using [this document].
◉ Training records. Answer: A controlled document that contains
documentation of employee training on GMP procedures, processes,
and equipment use.
◉ Training records. Answer: Human Resources (HR) maintains
records of employee training and qualifications, and Quality
Assurance (QA) ensures that employees are trained and that training
records are up-to-date using [these documents]
◉ Equipment Maintenance Records. Answer: A controlled document
that contains documentation of maintenance, calibration, and
repairs of equipment used in manufacturing
◉ Equipment Maintenance Records. Answer: Facilities/Maintenance
maintains records of routine maintenance, repairs, and calibration
activities using [these documents]; Production/Manufacturing
provides input on equipment performance and any issues
encountered
◉ Validation Documents. Answer: A controlled document that
contains records related to the validation of processes, equipment,
and systems to ensure they meet predefined specifications.
, ◉ Validation Documents. Answer: Quality Assurance (QA) Oversees
validation activities and documentation with [these documents];
Engineering conducts and documents validation of equipment and
processes using [these documents]
◉ Regulatory Submissions and Correspondence. Answer: A
controlled document that contains documentation related to
submissions for product approvals, regulatory inspections, and
communication with regulatory agencies.
◉ Regulatory Submissions and Correspondence. Answer: Regulatory
Affairs prepares and submits regulatory documents and manages
correspondence with regulatory bodies.
◉ Environmental Monitoring Records. Answer: A controlled
document that contains records of environmental monitoring, such
as air quality, cleanliness, and temperature control within
manufacturing areas.
◉ Environmental Monitoring Records. Answer: Quality Control (QC)
monitors and documents environmental conditions using [these
documents]; Facilities ensures that environmental control systems
are functioning properly using [these documents]
