WorksheetsQA QC cGMP
Total questions: 30
Worksheet time: 15mins
Quality Control is a ____ tool
Preventive
Corrective
Managerial
Distribution
_____ regulations must be followed by drug manufacturing companies
GMP
cGMP
GWP
GGP
_____ is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies
GMP
GLP
GCP
GDP
____ regulates drug products defined in FDA
CSER
CDER
CEFB
CBRE
Storage, retention and retrieval of documents is a responsibility of ____
R&D Dept
QC Dept
QA Dept
Stores Dept
Packaging and Labeling control is a part of ____
GLP
GMP
GDP
GCP
____ ensures consistency in daily operations
SOPs
Quality assurance
Quality Control measures
Material analysis
CDER stands for _____
Center for Drug Research and Evaluation
Center for Drug and Research
Center for Drug Evaluation and Research
Center for Drug Evaluation and Review
CBER stands for ______
Center for Biological Evaluation
Central Biological Evaluation and Research
Center for Biologics Evaluation and Review
Center for Biologics Evaluation and Research
EMEA stands for ____
European Medical Evaluation Agent
European Medicines Evaluation Agency
European Medicines Enterprise Agency
Europe Medicine Entry Agency
GMP applies to _____
API
Finished Goods
Both API and finished goods
None of the above
Which of the following are a part of building and facilities?
Storage area
Production area
Weighing area
All of the above
Any product that has completed all processing stages up to, but not including, final packaging is called ____
Bulk product
Final product
Packaged product
None
A dosage form that has undergone all stages of manufacture, including packaging in its final container and labelling is called ____
Bulk product
Finished product
API
None
GCP stands for ___
Good cleaning practices
Good clinical practices
Good carrying practices
Good cleaning and dispensing practices
GMP covers_____
personnel
building premises
sanitation and hygiene
All of the above
Rest and refreshment rooms are part of ___
Storage area
Dispensing area
Ancillary area
None of the above
GWP includes_____
Purchase of pharmaceutical products.
Storage of ordered products
Distribution of stocked products
All of the above
REJECTED MATERIALS area includes____
Receiving area
Sampling area
Dispensed products
Destroyed or unsuitable materials
____ is a part of the Drugs and Cosmetics Act of 1945 that outlines the Good Manufacturing Practices (GMP) for pharmaceutical products in India
Schedule O
Schedule P
Schedule N
Schedule M
According to Schedule M, which of the following is a primary responsibility of production personnel?
To approve batch release
To ensure products are manufactured and stored as per documented procedures
To conduct internal audits
To approve vendor qualification documents
Under USFDA (CDER/CBER) guidelines, training of personnel must be:
Conducted only once during induction
Documented and evaluated periodically for effectiveness
Optional for senior management
Performed only by external consultants
WHO cGMP requires personnel hygiene programs to include all except
Use of protective garments
Periodic health checks
Mandatory annual leave
Training in personal hygiene practices
As per Schedule M, the location of a drug manufacturing unit should ideally
Be close to densely populated residential areas
Be situated in an industrial area with minimal environmental contamination
Be near agricultural land for easy waste disposal
Have no restrictions on surrounding activities
EU (EMA) GMP guidelines emphasize that the plant layout must:
Encourage unidirectional flow of materials and personnel
Allow free and random movement of personnel
Support common change rooms for sterile and non-sterile operations
Have no segregation for high-risk areas
During a USFDA inspection, investigators find that three operators involved in aseptic filtration lack documented training for a newly introduced sterile filter integrity test.
Which is the MOST appropriate regulatory observation?
Inadequate maintenance of QMS audits
Failure to qualify personnel as per 21 CFR 211.25
Failure to validate utilities as per EMA Annex 1
Poor plant layout design per Schedule M
A purified water loop repeatedly exceeds microbial limits. Investigators find that sanitization frequency was increased informally without updating SOPs.
What is the KEY compliance failure?
Not performing change control as per PIC/S
Not monitoring temperature continuously
Incorrect HVAC classification
Inadequate operator hygiene program
A facility’s compressed air used for product contact intermittently fails dew-point specifications, but engineering logs only note “machine serviced—OK.”
Which regulatory issue is most significant?
Lack of documented preventive maintenance as per Schedule M
Improper HVAC zoning
MA requirement on computerized system validation
WHO requirement for handwashing facilities
During a Schedule M audit, the inspector reviews personnel files and finds no written job descriptions for key roles such as production chemist, QA reviewer, and engineering supervisor.
What is the most significant cGMP risk?
Inability to calculate manpower cost accurately
Ambiguity in responsibilities leading to accountability failures
Inconsistent cleaning of AHUs
Reduced efficiency in water system sanitization
PIC (or PIC/S) stands for:
Pharmaceutical Inspection Convention / Scheme
Pharmaceutical Industry Council / Scheme
Public Inspection Committee
Pharma Investigation Council
