BACE - Biotechnician Assistant Credentialing Good Manufacturing Practices (cGMP) Questions and Answers

Question 1

A biotechnician makes an error while completing a paper-based Batch Production Record (BPR). According to cGMP Good Documentation Practices, what is the correct procedure for making the correction?

Accepted Answer

Draw a single line through the incorrect entry, write the correct information, then add one's initials and the date.

Answer

Use correction fluid to neatly cover the error, then write the correct information on top.

Answer

Completely obscure the incorrect entry with a black marker and write the correct data nearby.

Answer

Request a new, clean copy of the BPR from the Quality Assurance department and discard the one with the error.

Question 2

In a cGMP-compliant facility, which department is primarily responsible for the hands-on testing of raw materials, in-process samples, and finished products against established specifications?

Accepted Answer

Quality Control (QC)

Answer

Quality Assurance (QA)

Answer

Research and Development (R&D)

Answer

Manufacturing

Question 3

During a manufacturing run, a technician discovers that a critical buffer was prepared using an uncalibrated pH meter. This event represents a departure from the approved Standard Operating Procedure (SOP). Under cGMP, what is this event called?

Accepted Answer

A Deviation

Answer

A Corrective Action

Answer

A Validation Failure

Answer

An Audit Finding

Question 4

Which of the following activities is a core responsibility of the Quality Assurance (QA) department in a biotechnology company?

Accepted Answer

Reviewing and approving Batch Production Records before product release.

Answer

Performing identity testing on incoming raw materials.

Answer

Executing the steps of a manufacturing process.

Answer

Calibrating laboratory analytical balances.

Question 5

The cGMP data integrity principle of 'ALCOA+' ensures that documentation is reliable. The 'C' in ALCOA+ stands for which of the following?

Accepted Answer

Contemporaneous

Answer

Complete

Answer

Consistent

Answer

Controlled

Question 6

A new bioreactor is installed in a cGMP manufacturing suite. The process of generating documented evidence that the equipment has been installed correctly and according to the manufacturer's specifications is known as:

Accepted Answer

Installation Qualification (IQ)

Answer

Performance Qualification (PQ)

Answer

Process Validation (PV)

Answer

Operational Qualification (OQ)

A biotechnician makes an error while completing a paper-based Batch Production Record (BPR).According to cGMP Good Documentation Practices, what is the correct procedure for making the correction?

A biotechnician makes an error while completing a paper-based Batch Production Record (BPR).
According to cGMP Good Documentation Practices, what is the correct procedure for making the correction?