GMP TMHS (NPRA) PRE POST TEST

Which of the following best describes the main goal of GMP?

• To prevent contamination and errors in manufacturing

• To increase the speed of production

• To ensure low-cost manufacturing

• To meet sales targets

A company producing TMHS products receives a batch of raw materials without a Certificate of Analysis (CoA). What should be done?

• Proceed with production since the material looks fine

• Send it for internal testing before use

• Use it only in small quantities to reduce risk

• Reject the materials and request a CoA from the supplier

In GMP, who is responsible for ensuring compliance with SOPs (Standard Operating Procedures)?

• Only the Quality Control (QC) team

• The production department

• Every employee involved in the manufacturing process

• Only the GMP inspector during audits

Why is it important to have a dedicated area for raw materials in a GMP facility?

• To ensure that raw materials are always available for production

• To prevent cross-contamination with finished products

• To make it easier for workers to access them quickly

• To reduce warehouse space requirements

What is the primary purpose of a stability study for TMHS products?

• To check how long a product remains effective and safe under storage conditions

• To test whether the product can be manufactured faster

• To determine the color changes in packaging

• To check employee handling of the product

Which of the following is NOT an acceptable GMP practice when handling raw materials?

• Conducting identity and quality tests before use

• Keeping raw materials in properly labeled storage areas

• Mixing new raw materials with leftover stock from previous batches

• Recording batch numbers and expiry dates of all raw materials

Why must deviations in GMP processes be documented and investigated?

• To provide an explanation for audits and inspections

• To determine if corrective and preventive actions (CAPA) are required

• To allow continuous improvement in manufacturing practices

• All of the above

What should an employee do if they notice an environmental issue (e.g., water leakage, pest activity) in the GMP facility?

• Ignore it if it does not affect production

• Inform their supervisor and record the issue immediately

• Try to fix the issue themselves without reporting

• Continue working and report it at the end of the shift

Why is it important for GMP facilities to have controlled access to production areas?

• To reduce distractions for workers

• To limit contamination and unauthorized entry

• To keep production secret from competitors

• To prevent employees from leaving the area

What is the purpose of a GMP self-inspection program?

• To ensure that only senior management is aware of GMP compliance

• To prepare employees for external audits without making actual changes

• To identify and correct potential GMP violations before regulatory audits

• To meet legal requirements without affecting production efficiency