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WorksheetsGMP TMHS (NPRA) PRE POST TEST
Total questions: 10
Worksheet time: 5mins
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
