BACE - Biotechnician Assistant Credentialing Good Manufacturing Practices (cGMP) Questions and Answers 1

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

cGMP requires that all data corrections be traceable and that the original entry remains legible. Drawing a single line through the error, adding the correction, and then initialing and dating it ensures there is a clear, attributable audit trail for the change.

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 Control (QC) is the operational unit responsible for performing the physical and chemical tests on samples to ensure they meet predetermined specifications. Quality Assurance (QA) is responsible for the overall quality system and processes to prevent errors, but does not typically perform the routine lab testing.

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 deviation is any departure from an approved instruction, procedure, specification, or established standard. Using an uncalibrated instrument is a clear departure from the established procedure and must be documented and investigated as a deviation.

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

Quality Assurance (QA) is responsible for the overall quality system, which includes the final review and approval of all production and control records to ensure cGMP compliance before a product batch is released for distribution. The other tasks are performed by QC (testing), Manufacturing (execution), and either a metrology or QC department (calibration).

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

The 'C' in the ALCOA acronym stands for Contemporaneous, which means that all activities, events, or data should be recorded at the time they are performed or observed. This practice ensures accuracy and prevents data integrity issues like backdating.

BACE - Biotechnician Assistant Credentialing Exam Practice Test

BACE - Biotechnician Assistant Credentialing Exam Practice Test

BACE - Biotechnician Assistant Credentialing Good Manufacturing Practices (cGMP) Questions and Answers 1