BPF Game: Evaluation MCQ

Here is a list of 50 multiple-choice questions (MCQs) based on the 9 chapters of Good Manufacturing Practices (GMP), with answers indicated. These questions cover key points from each chapter.

 

Chapter 1 : Quality Management System

 

What is the main objective of a quality management system?

  1. Reduce production costs
  2. Ensure the quality of pharmaceutical products ✅
  3. Facilitate internal audits
  4. Optimize logistics

What does the term “quality assurance” mean?

  1. Cost reduction
  2. Compliance with regulatory requirements ✅
  3. Testing of finished products
  4. Streamlining processes

Which document describes responsibilities and procedures?

  1. A validation plan
  2. A quality manual ✅
  3. A work instruction
  4. An audit report

How often should the quality management system be reviewed?

  1. Every month
  2. Once a year ✅
  3. Every five years
  4. Every quarter

 

 

Chapter 2 : Staff

 

What is the main role of staff in GMP?

  1. Minimize costs
  2. Comply with procedures ✅
  3. Create new formulations
  4. Increase sales

What training is mandatory for all employees?

  1. Health and safety training ✅
  2. Marketing training
  3. Logistics training
  4. IT training

Why do staff need to wear appropriate clothing?

  1. To identify their role
  2. To avoid contamination ✅
  3. To improve their comfort
  4. For fashion reasons

Who is responsible for continuing education?

  1. The marketing department
  2. The quality manager ✅
  3. The logistics department
  4. The staff themselves

 

Chapter 3 : Premises and equipment

 

What is an essential feature for the premises?

  1. Attractive decor
  2. A design that allows for easy cleaning ✅
  3. Large storage capacity
  4. Proximity to suppliers

The flow of materials and personnel must be:

  1. Linear and intersecting
  2. Separate and controlled ✅
  3. Random and rapid
  4. Unmonitored

What equipment is subject to qualification?

  1. All critical equipment ✅
  2. Only computers
  3. Transport vehicles
  4. Equipment not in use

What is the recommended frequency for equipment maintenance?

  1. Daily
  2. Weekly
  3. According to a validated maintenance plan ✅
  4. Annually

 

 

Chapter 4 : Documentation

 

What is the purpose of documentation?

  1. Follow market trends
  2. Provide clear instructions ✅
  3. Save production time
  4. Reduce costs

Which document contains the product specifications?

  1. Batch record
  2. Specifications file ✅
  3. Audit report
  4. Validation plan

What should I do if a document is corrected?

  1. Use whiteout
  2. Rewrite the document
  3. Delete the error, justify, stamp, and date it ✅
  4. Do nothing

Which type of document is most critical?

  1. Payroll slips
  2. Standard operating procedures (SOPs) ✅
  3. Financial reports
  4. Delivery notes

 

 

Chapter 5 : Production

 

What are the purposes of production instructions?

  1. Increase productivity
  2. Ensure reproducibility ✅
  3. Reduce costs
  4. Facilitate audits

When should an in-process inspection be performed?

  1. At the end of each step ✅
  2. Before production starts
  3. Once a day
  4. Once per batch

What should I do if a deviation occurs?

  1. Increase productivity
  2. Ensure reproducibility ✅
  3. Reduce costs
  4. Facilitate audits

Why can’t a nonconforming product be released?

  1. To meet production deadlines
  2. To protect public health ✅
  3. To avoid costly recalls
  4. To improve brand image

 

 

Chapter 6 : Quality Control

 

What is the primary mission of quality control?

  1. Reduce costs
  2. Ensure products meet specifications ✅
  3. Increase production volumes
  4. Check packaging

What type of sampling is used to release a lot?

  1. Random
  2. Statistically representative ✅
  3. At the technician’s discretion
  4. No sampling required

Who can approve test results?

  1. Production personnel
  2. A qualified quality analyst ✅
  3. Any employee
  4. The marketing department

Retention samples must be retained:

  1. For the entire product life + 1 year ✅
  2. Indefinitely
  3. Only 6 months
  4. Until the audit is completed

Chapter 7: Outsourced Activities

 

What should be checked before outsourcing an activity?

  1. The subcontractor’s skills ✅
  2. The rates charged
  3. The delivery time
  4. The number of employees

A subcontracting contract must include:

  1. Product specifications ✅
  2. Working hours
  3. Audit reports
  4. Pay slips

Who is responsible for the compliance of an outsourced activity?

  1. The subcontractor
  2. The client ✅
  3. External auditors
  4. The health authority

Subcontractor audits must be conducted:

  1. Once a year ✅
  2. Every month
  3. Every five years
  4. Only once, before the contract

 

Chapter 8 : Complaints and Recalls

 

What to do in the event of a customer complaint?

  1. Ignore it
  2. Analyze and document it ✅
  3. Return the product free of charge
  4. Inform the authorities

Who decides on a product recall?

  1. The marketing department
  2. The quality manager ✅
  3. Production staff
  4. The distributor

Complaints must be kept for:

  1. 5 years ✅
  2. 1 year
  3. 10 years
  4. Indefinitely

During a recall, it is important to:

  1. Minimize costs
  2. Immediately inform the authorities ✅
  3. Reduce production volumes
  4. Accelerate deliveries

 

 

Chapter 9 : Self-inspection

 

What is the main objective of self-inspections?

  1. Identify areas for improvement ✅
  2. Reduce costs
  3. Train employees
  4. Satisfy auditors

How often should a self-inspection be performed?

  1. Once a week
  2. Once a year ✅
  3. Once every two years
  4. Every month

Who should be involved in self-inspections?

  1. The logistics department
  2. A qualified and independent team ✅
  3. Administrative staff
  4. Customers

What should be done after a self-inspection?

  1. Note any deviations that are not addressed
  2. Implement corrective actions ✅
  3. Conduct an external audit
  4. Stop production

 

 

Here is a series of more complex questions for each chapter.

 

Chapter 1 : Quality Management System

An internal audit has revealed minor nonconformities in the quality documentation. What is the best course of action?

  1. Correct them immediately without additional documentation
  2. Record them, analyze the causes, and implement corrective and preventive actions (CAPA) ✅
  3. Postpone the correction until the next audit
  4. Inform only the relevant department

During a product quality review (PQR), an increase in deviations is observed for a specific batch. What is the priority action?

  1. Stop production and inform the authorities
  2. Initiate a thorough investigation and examine the potential impact on other batches ✅
  3. Immediately revise the manufacturing protocol
  4. Add quality controls on the finished product

 

 

Chapter 2 : Staff

 

A newly hired technician performs a critical operation without prior training. What is the most likely consequence on GMP compliance?

  1. None, as long as they are supervised
  2. A major deviation, as training is mandatory before any critical task ✅
  3. A minor non-compliance, correctable after the fact
  4. A revision of the SOPs to include exceptions

During an audit, it is revealed that staff are not following gowning protocols in a sterile area. What is the best corrective action?

  1. Rewrite the gowning SOPs
  2. Organize targeted training on gowning practices in the sterile area ✅
  3. Prevent these staff from entering the sterile area
  4. Install a camera surveillance system

 

 

Chapter 3 : Premises and equipment

 

Cross-contamination has been detected between two production lines. What immediate action should be taken according to GMP?

  1. Stop production, investigate the cause, and requalify the affected lines. ✅
  2. Perform enhanced cleaning and restart the lines immediately.
  3. Perform enhanced quality control on the affected batches.
  4. Inform only the line operators.

During the qualification of new equipment, you detect a temperature variation in a critical storage enclosure. What should you do?

  1. Accept the equipment if the variation remains within the manufacturer’s tolerances.
  2. Suspend qualification, analyze the cause, and adjust the equipment or parameters. ✅
  3. Install a monitoring system to compensate for the variation.
  4. Continue qualification, noting the deviation.

 

Chapter 4 : Documentation

 

An employee made a correction to a batch record without providing the date or initials. What should you do according to GMP?

  1. Inform the auditor in case of an upcoming inspection
  2. Initiate a deviation and educate staff on good documentation practices ✅
  3. Discard the document and request a complete rewrite
  4. Add the correction manually with an external signature

When developing a standard operating procedure (SOP), what are the critical elements to include to ensure compliance?

  1. A description of key steps, responsibilities, and regulatory references ✅
  2. A detailed list of all equipment used
  3. A general summary without specific instructions
  4. A description of the quality control processes only

 

 

Chapter 5 : Production

 

You detect a variation in the average tablet weight during a production run. What is the first step to take?

  1. Immediately stop the production line for a thorough inspection ✅
  2. Continue production and adjust the parameters for the next batch
  3. Inform the end customer and re-evaluate the formula
  4. Replace operators to minimize errors

During manufacturing, a critical step was not performed correctly, but the final product meets specifications. What should you do?

  1. Release the product because it meets specifications
  2. Hold the batch and initiate a quality impact investigation ✅
  3. Perform enhanced inspections only on finished products
  4. Revise SOPs to avoid repetition

 

Chapter 6 : Quality Control

 

During a stability test, a batch shows accelerated degradation of an active ingredient. What is the best course of action?

  1. Immediately revise the shelf life for all batches
  2. Initiate an investigation to determine if the problem is batch or process related ✅
  3. Perform additional testing on unaffected samples
  4. Notify health authorities directly

You discover that an analyst omitted a required test for a released product. What is the priority corrective action?

  1. Inform customers immediately
  2. Retest the product if samples are still available ✅
  3. Modify SOPs to prevent future omissions
  4. Reassess the entire quality system

 

 

Chapter 7 : Outsourced Activities

 

A subcontractor refuses to share their internal audit reports. What should you do?

  1. Accept the situation if their GMP certificates are valid
  2. Conduct your own audit to assess compliance ✅
  3. Terminate the contract immediately
  4. Trust the subcontractor’s reputation

A critical analysis reveals that the subcontractor has not met the requirements of the quality contract. What should you do?

  1. Ask them to correct the deviations and continue working together ✅
  2. Terminate the contract immediately and transfer production
  3. Inform the health authorities without prior investigation
  4. Reduce the volumes entrusted to the subcontractor

 

 

Chapter 8 : Complaints and Recalls

 

A complaint reveals a labeling error on a batch already distributed. What is the best course of action?

  1. Initiate a recall immediately ✅
  2. Send a label correction to customers
  3. Inform only the affected distributors
  4. Relabel the products still in stock

During a recall, you realize that the traceability information is incomplete. What should you do?

  1. Continue the recall with the available data ✅
  2. Wait to collect all the information
  3. Temporarily suspend the recall
  4. Inform customers that complete tracking is not possible

 

 

Chapter 9 : Self-inspection

 

A self-inspection reveals a critical nonconformity that was not detected during the previous audit. What is the best approach?

  1. Initiate a CAPA and strengthen the audit criteria ✅
  2. Immediately organize a new external audit
  3. Conduct an investigation of the previous audit team
  4. Ignore the nonconformity if it is minor

During a self-inspection, minor deviations from the SOPs are identified. What should I do?

  1. Correct them immediately and document the changes ✅
  2. Wait for the annual audit to report deviations
  3. Conduct a complete review of all SOPs
  4. Inform only the affected operators

 

 

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