Inter-University Online Quiz Competition on cGMP

JavaScript isn't enabled in your browser, so this file can't be opened. Enable and reload.

Note: 15 minutes are allotted for 25 questions.

Email *

What is the primary goal of cGMP?

a) To meet regulatory requirements

b) To reduce production costs

c) To increase product yield

d) To ensure product quality and safety

Clear selection

Untitled Title

What is the purpose of the Annual Product Review (APR) in GMP?

a) Assess employee performance

b) Evaluate market trends

c) Review the quality of the product over time

d) Plan future marketing strategies

Clear selection

In GMP, what does “CAPA” stand for?

a) Corrective Action and Preventive Action

b) Continuous Automated Production Assembly

c) Customer Acquisition and Product Assessment

d) Current Analysis of Production Activities

Clear selection

Which of the following is a critical aspect of cGMP documentation?

a) Batch Manufacturing Record (BMR)

b) Standard Operating Procedure (SOP)

c) Both a and b

d) None of the above

Clear selection

What is the role of the Regulatory Affairs department in GMP?

a) Maximize production efficiency

b) Ensure compliance with regulatory requirements

c) Manage employee benefits

d) Monitor market competition

Clear selection

Records of returned drug products must be maintained and contain the appropriate information. Which of the following is not specifically listed in the cGMPs in this subsection.

a) Date of distribution

b) Ultimate disposition of the returned drug product

c) Amount or number of drug product returned

d) None of them

Clear selection

In a cGMP pharmaceutical manufacturing facility, what type of buildings should maintain "a clean and sanitary condition", as specifically specified the CFR 211?

a) Any building used in the processing, packing, or holding of an ingredient.

b) Any building used in the processing, packing, or holding of an drug product.

c) Any building used in the manufacture, processing, packing, or holding of a drug product.

d) Any building used in the manufacture, processing, packing, or holding of an ingredient.

Clear selection

What is the primary goal of cGMP sensitization training?

a) To teach employees about company policies

b) To ensure compliance with regulatory requirements

c) To educate employees on the importance of quality and safety

d) To improve production efficiency

Clear selection

Which document outlines the steps for a specific manufacturing process?

a) Batch Manufacturing Record (BMR)

b) Master Production Record (MPR)

c) Standard Operating Procedure (SOP)

d) Quality Control Report (QCR)

Clear selection

ICH Q 7 represents ________ guidelines.

a. Quality Risk Management

b. Good Manufacturing Practices

c. Lifecycle management

d. Pharmaceutical Development

Clear selection

Drug products must be stored under appropriate conditions. Which is not a condition mentioned in the cGMPs.

a) Light

b) Temperature

c) Sterility

d) Humidity

Clear selection

What is not the consequence of non-compliance with cGMP regulations?

a) Benefit of customer

b) Regulatory action

c) Damage to company reputation

d) Product recall

Clear selection

Which of the following is not a benefit of implementing cGMP in pharmaceutical production?

a) Reduced risk of contamination

b) Improved product quality

c) Increased regulatory compliance

d) Improved product cost

Clear selection

Who should receive cGMP sensitization training?

a) Only quality control personnel

b) Only production personnel

c) Only management personnel

d) All employees involved in manufacturing, testing, and distribution

Clear selection

What is the role of the Quality Unit in GMP?

a) Maximize production efficiency

b) Ensure compliance with regulatory requirements

c) Manage human resources

d) Monitor marketing strategies

Clear selection

What does "Validation" mean in the context of cGMP?

a) Testing products for quality

b) Documenting manufacturing processes

c) Establishing evidence that a process consistently produces quality products

d) Conducting audits and inspections

Clear selection

What is the consequence of a cGMP violation in pharmaceutical manufacturing?

a) Product recall

b) Plant shutdown

c) Regulatory warning letter

d) All of the above

Clear selection

Which regulatory body is responsible for enforcing cGMP guidelines in India?

a) CDSCO (Central Drugs Standard Control Organisation)

b) WHO (World Health Organization)

c) USFDA (United States Food and Drug Administration)

d) EMA (European Medicines Agency)

Clear selection

Which one is the theme of the 2025 National cGMP Day?

a) Think cGMP-cGMP is Quality

b) cGMP: Transforming Healthcare

c) cGMP for Sustainable Quality

d) Ensure Patient Safety: Follow cGMP

Clear selection

How often should cGMP sensitization training be conducted?

a) Only once during onboarding

b) Annually or as needed

c) Quarterly

d) Monthly

Clear selection

cGMPs require that all equipment and utensils be sanitised and/or sterilised between each batch.

a) True

b) False

Clear selection

According to the cGMPs, distribution records must contain the following information, Except:

a) Name and address of consignee

b) Name of patient

c) Date and quantity shipped

d) Description of dosage form

Clear selection

What does cGMP ensure in terms of product quality?

a) Consistency in manufacturing processes

b) Accuracy in labeling and packaging

c) Purity and potency of active ingredients

d) All of the above

Clear selection

What is the purpose of Quality Control (QC) in cGMP?

a) To ensure production efficiency

b) To test raw materials and finished products

c) To manage supply chain logistics

d) To handle customer complaints

Clear selection

Who is responsible for ensuring cGMP compliance?

a) Quality Control department

b) Production department

c) All personnel involved in manufacturing

d) Regulatory affairs department

Clear selection

Submit

Clear form

This content is neither created nor endorsed by Google. - Terms of Service - Privacy Policy

Does this form look suspicious? Report

Forms