Documentation system in pharmaceutical industry is the framework that ensures accurate creation, control, revision, distribution, retention, and retrieval of quality and regulatory records. For B. Pharm students, mastery of Good Documentation Practices (GDP), Standard Operating Procedures (SOPs), batch manufacturing and packaging records, data integrity principles (ALCOA+), validation documentation, change control, and archival requirements is essential. A strong documentation system underpins GMP compliance, traceability, audit readiness, product quality, and regulatory submissions (FDA/EMA/ICH). Practical understanding of controlled copies, training records, electronic vs. paper records, and audit trails prepares you for QA, production, regulatory affairs, and validation roles. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of a documentation system in the pharmaceutical industry?
- To reduce production costs by cutting paperwork
- To record, control, and preserve information required for GMP compliance
- To replace quality testing with paperwork
- To create marketing materials for products
Correct Answer: To record, control, and preserve information required for GMP compliance
Q2. Which principle best describes ALCOA in data integrity?
- Accurate, Local, Current, Operable, Available
- Attributable, Legible, Contemporaneous, Original, Accurate
- Accessible, Logged, Controlled, Organized, Auditable
- Approved, Locked, Controlled, Observed, Archived
Correct Answer: Attributable, Legible, Contemporaneous, Original, Accurate
Q3. Which document is considered the primary record of production details for each manufactured batch?
- Master Formula Record
- Batch Manufacturing Record
- SOP for Equipment Cleaning
- Deviation Report
Correct Answer: Batch Manufacturing Record
Q4. What is the purpose of a Master Formula Record (MFR)?
- To record deviations for a single batch
- To provide a detailed, standardized recipe and instructions for product manufacture
- To document laboratory stability data
- To describe marketing claims for a product
Correct Answer: To provide a detailed, standardized recipe and instructions for product manufacture
Q5. Which of the following is a key element of Good Documentation Practices (GDP)?
- Use pencil for all entries
- Make retrospective entries without annotation
- Ensure entries are dated, signed, and legible
- Allow anyone to modify records without authorization
Correct Answer: Ensure entries are dated, signed, and legible
Q6. In electronic documentation systems, what feature most supports data integrity?
- Decorative dashboards
- Read-only PDF exports only
- Secure audit trails that record who changed what and when
- Unlimited user accounts with shared passwords
Correct Answer: Secure audit trails that record who changed what and when
Q7. Which document controls the authorized distribution and controlled copies of SOPs?
- Change Control Log
- Document Master List or Document Control Procedure
- Equipment Logbook
- Batch Manufacturing Record
Correct Answer: Document Master List or Document Control Procedure
Q8. What is the correct action when a handwritten error is made in a paper batch record?
- Erase the error cleanly
- Leave it as is and ignore
- Strike through with a single line, initial, date, and add correction
- Use opaque tape to cover the error
Correct Answer: Strike through with a single line, initial, date, and add correction
Q9. Which regulatory guidance emphasizes computerized system validation and electronic records?
- ICH Q10
- EU GMP Annex 11
- WHO TRS Chapter only
- Pics GMP Guide Annex X
Correct Answer: EU GMP Annex 11
Q10. How long should critical pharmaceutical records typically be retained?
- One week
- Until the next batch is produced
- As defined by regulatory requirement, product lifecycle, and company policy (often years)
- Only during the qualification period
Correct Answer: As defined by regulatory requirement, product lifecycle, and company policy (often years)
Q11. Which document describes how to handle deviations discovered during manufacturing?
- Change Control Procedure
- Deviation/Nonconformance Procedure
- Calibration Log
- Training Matrix
Correct Answer: Deviation/Nonconformance Procedure
Q12. What is the purpose of a controlled copy of an SOP?
- To allow unofficial changes by operators
- To provide a single authorized version distributed under control
- To archive obsolete procedures indefinitely
- To be freely printed and modified by departments
Correct Answer: To provide a single authorized version distributed under control
Q13. Which record demonstrates personnel competency for a specific operation?
- Retention sample log
- Training record or competency assessment
- Packaging slip
- Quality audit schedule
Correct Answer: Training record or competency assessment
Q14. What is an audit trail in an electronic documentation system?
- A list of software users only
- A log that tracks creation, modification, and deletion of records with timestamps and user IDs
- A backup of the server every month
- A printed copy of electronic records
Correct Answer: A log that tracks creation, modification, and deletion of records with timestamps and user IDs
Q15. Which document would include acceptance criteria and testing procedures for raw materials?
- Master Formula Record
- Specification and Test Method documents
- Equipment maintenance log
- Marketing dossier
Correct Answer: Specification and Test Method documents
Q16. What is the main objective of document change control?
- To prevent any updates to documents
- To manage and authorize document revisions to ensure current versions are used
- To increase the number of documents
- To allow immediate informal changes by operators
Correct Answer: To manage and authorize document revisions to ensure current versions are used
Q17. Which practice supports traceability in a documentation system?
- Assigning batch numbers and linking records to raw materials and equipment logs
- Keeping records only in the QA office
- Removing signatures after production
- Using different formats for the same record type
Correct Answer: Assigning batch numbers and linking records to raw materials and equipment logs
Q18. During an inspection, an auditor requests historical validation reports. Where should these be located?
- In the cafeteria
- In the validation documentation archive or electronic document management system
- Only in the personal files of engineers
- Deleted after validation completion
Correct Answer: In the validation documentation archive or electronic document management system
Q19. Which of the following best describes “retention samples” and their documentation?
- Samples discarded immediately after production
- Samples kept from a batch with documented storage conditions for stability and investigation
- Samples used for operator training only
- Samples that do not require labeling or logs
Correct Answer: Samples kept from a batch with documented storage conditions for stability and investigation
Q20. What should be included in a document master list?
- Only titles without revision status
- Document titles, identification numbers, revision status, effective dates, and controlled copy locations
- Personal opinions about documents
- Passwords for the document system
Correct Answer: Document titles, identification numbers, revision status, effective dates, and controlled copy locations
Q21. How should electronic signatures be handled to meet regulatory expectations?
- Shared among team members for convenience
- Uniquely identifiable, linked to the record, and secured with user authentication
- Used only on printed records
- Logged without time or user details
Correct Answer: Uniquely identifiable, linked to the record, and secured with user authentication
Q22. Which document governs calibration frequency and acceptance criteria for instruments?
- Calibration Procedure and Equipment Log
- Master Formula Record
- SOP for waste disposal
- Marketing brochure
Correct Answer: Calibration Procedure and Equipment Log
Q23. What is a primary benefit of electronic Document Management Systems (eDMS)?
- Unlimited anonymous edits
- Centralized control of versions, access rights, and audit trails
- Automatic deletion of old documents
- Replacement of SOPs with emails
Correct Answer: Centralized control of versions, access rights, and audit trails
Q24. Which action is required when a critical deviation impacts product quality?
- Ignore and continue production
- Initiate investigation, document root cause, implement CAPA, and record in deviation report
- Destroy all records immediately
- Change records to hide the deviation
Correct Answer: Initiate investigation, document root cause, implement CAPA, and record in deviation report
Q25. What is the role of retention and archiving policies in a documentation system?
- To ensure records are kept or disposed of according to defined timelines and regulations
- To eliminate historical data as soon as possible
- To allow anyone to remove records at will
- To prevent any backups
Correct Answer: To ensure records are kept or disposed of according to defined timelines and regulations
Q26. In paper record management, what ensures that only the latest SOP is used on the shop floor?
- Leaving old SOPs on notice boards
- Controlled distribution of current SOPs and removal or withdrawal of superseded copies
- Allowing supervisors to use personal copies
- Printing SOPs on demand without tracking
Correct Answer: Controlled distribution of current SOPs and removal or withdrawal of superseded copies
Q27. Which documentation is crucial for validating a computerized system?
- Validation Plan, IQ/OQ/PQ protocols and reports, and traceability matrices
- Only the user manual
- Only the marketing plan
- Random screenshots without context
Correct Answer: Validation Plan, IQ/OQ/PQ protocols and reports, and traceability matrices
Q28. What information must be present on labels and log entries for retained samples?
- Only the storage location
- Batch number, product name, date, storage conditions, and unique sample ID
- Confidential project codes only
- Only the operator’s initials
Correct Answer: Batch number, product name, date, storage conditions, and unique sample ID
Q29. Which document typically requires approval signatures before becoming effective?
- Internal meeting minutes only
- SOPs, Master Formula Records, and critical quality documents
- Personal notes of technicians
- Informal emails
Correct Answer: SOPs, Master Formula Records, and critical quality documents
Q30. How does training documentation contribute to a compliant documentation system?
- By recording who is trained on procedures and ensuring competency for documented tasks
- By serving as marketing material
- By replacing the need for SOPs
- By allowing unqualified personnel to sign records
Correct Answer: By recording who is trained on procedures and ensuring competency for documented tasks
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com