BACE - Biotechnician Assistant Credentialing Good Manufacturing Practices (cGMP) Questions and Answers 1 — 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?
- Use correction fluid to neatly cover the error, then write the correct information on top.
- Completely obscure the incorrect entry with a black marker and write the correct data nearby.
- Draw a single line through the incorrect entry, write the correct information, then add one's initials and the date. (Correct answer)
- Request a new, clean copy of the BPR from the Quality Assurance department and discard the one with the error.
Correct answer: Draw a single line through the incorrect entry, write the correct information, then add one's initials and the date.
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?
- Quality Assurance (QA)
- Quality Control (QC) (Correct answer)
- Research and Development (R&D)
- Manufacturing
Correct answer: Quality Control (QC)
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?
- A Corrective Action
- A Validation Failure
- A Deviation (Correct answer)
- An Audit Finding
Correct answer: A Deviation
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?
- Reviewing and approving Batch Production Records before product release. (Correct answer)
- Performing identity testing on incoming raw materials.
- Executing the steps of a manufacturing process.
- Calibrating laboratory analytical balances.
Correct answer: Reviewing and approving Batch Production Records before product release.
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?
- Complete
- Consistent
- Controlled
- Contemporaneous (Correct answer)
Correct answer: Contemporaneous
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.
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:
- Performance Qualification (PQ)
- Installation Qualification (IQ) (Correct answer)
- Process Validation (PV)
- Operational Qualification (OQ)
Correct answer: Installation Qualification (IQ)
Installation Qualification (IQ) is the documented verification that equipment and its components have been properly installed and configured according to the manufacturer's specifications and design requirements. It is the first step in the equipment qualification process, followed by Operational Qualification (OQ) and Performance Qualification (PQ).
BACE - Biotechnician Assistant Credentialing Good Manufacturing Practices (cGMP) Questions and Answers 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?