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BTC 181 Exam Review Questions & Answers 2024/2025

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BTC 181 Exam Review Questions &
Answers 2024/2025

Adulterated - ANSWERSA product does not meet all of the quality attributes

Misbranded - ANSWERSWhen a product contains incorrect label

Calibration - ANSWERSProcess to ensure the accuracy of instruments

Reconciliation - ANSWERSProcess of accounting for all of the starting material

Define each letter of the acronym ALCOA - ANSWERSAttributable, Legible, Contemporaneous, Original,
Accurate

International Council for Harmonization - ANSWERSAn international organization with the goal of
providing the industry with guidance on how to meet the requirements of multiple regulatory agencies.

Data Integrity - ANSWERSThe completeness, consistency, and accuracy of data over its lifecycle

Backwards Traceability - ANSWERSMaintaining the entire history of all materials for later investigation to
ensure that everything ever known about it can be retrieved if necessary.

Line Clearance - ANSWERSThe process of ensuring that all material from the previous batch is removed
from the production area.

Serialization - ANSWERSThe process of applying a unique serial number to each label.

, Explain the impact of low-quality biopharmaceutical products. - ANSWERSPoor quality products can
injure and even kill consumers. When quality is poor companies pay for it with damaged reputation, lost
customers, expensive lawsuits, high production cost, etc.

Explain the role and responsibilities of the quality control unit within a manufacturing company. -
ANSWERSQuality oversight responsibilities for a company. This group is made up of quality assurance,
quality control, quality systems and training.

What is FDA and describe their goal within a company and the types of audits they perform. -
ANSWERSThe FDA is responsible for protecting the public health by ensuring the safety, efficacy, and
security of human and veterinary drugs, biological products and medical devices. They review and
approve or reject applications for new products, oversee manufacturing and distribution activities,
review and approve or reject marketing materials, labeling and other promotional content and perform
research and laboratory testing to support public health. They can perform general inspections, pre-
approval inspections and for cause audits.

What are good documentation practices and explain their significance? - ANSWERSGood documentation
practices apply to all records covered under cGMPs to protect and manage record identity, authenticity,
accuracy, security, and retrievability.

What are some of the requirements of a process room during construction? - ANSWERSOperations must
be performed within specifically defined areas of adequate size. There shall be separate or defined areas
for the firm's operations to prevent contamination or mix ups. Floors, walls, and ceilings must be easy to
clean in order to prevent dust and particle build up that may lead to microbial growth.

What is required for a technician to be fully trained on a task and what tasks require training? -
ANSWERSReceives training on the SOPs, that govern assembly, receive training on relevant
documentation, demonstrate competence in procedures and techniques during the training

What is a deviation and list some examples? - ANSWERSA deviation is an event that does not conform to
the procedure or manufacturing process. Examples are a product sample result showed a lower strength
than specified, technician clocking in late for their shift, improper PPE for the task being performed.

Explain the difference between corrective and preventative maintenance. - ANSWERSCorrective
maintenance is unplanned maintenance and is a response to damage or breakdown. Preventative
maintenance is performed before equipment is damage and prevents deterioration and is scheduled.

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