Introduction: Effective record keeping requirements for experiments is essential for B.Pharm students to ensure accurate documentation, traceability, data integrity, and regulatory compliance. Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) principles guide laboratory notebooks, SOP adherence, batch records, calibration logs, electronic records, audit trails, and retention policies. Clear records support reproducibility, correct decision-making, deviation investigation, CAPA, and successful inspections by regulatory agencies. Learn proper techniques for contemporaneous entries, reliable corrections, secure storage, sample labeling, chain of custody, and validated electronic systems. Mastering these topics builds sound research habits and professional competence. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of keeping detailed experimental records in pharmaceutical labs?
- To create bulky paperwork to satisfy supervisors
- To ensure traceability, reproducibility and regulatory compliance
- To increase laboratory expenses
- To delay the publication process
Correct Answer: To ensure traceability, reproducibility and regulatory compliance
Q2. GLP stands for which of the following?
- General Laboratory Policy
- Good Laboratory Practice
- Guaranteed Lab Process
- Global Laboratory Procedures
Correct Answer: Good Laboratory Practice
Q3. Which of these is NOT part of the ALCOA principle for data integrity?
- Attributable
- Legible
- Contemporaneous
- Anonymous
Correct Answer: Anonymous
Q4. How should corrections be made in a paper laboratory notebook?
- Use correction fluid to hide the original entry
- Completely erase the original writing
- Strike through with a single line, initial, date and comment
- Leave the error without noting it
Correct Answer: Strike through with a single line, initial, date and comment
Q5. What qualifies as “original” raw data in an experiment?
- Handwritten summaries prepared weeks later
- Primary observations, instrument printouts or original electronic files
- Second-hand recollections from colleagues
- Published articles about similar work
Correct Answer: Primary observations, instrument printouts or original electronic files
Q6. Which practice ensures contemporaneous recording?
- Writing notes the week after the experiment
- Recording observations immediately when they occur
- Typing a summary at month end
- Asking someone else to note results later
Correct Answer: Recording observations immediately when they occur
Q7. What is essential for electronic laboratory records under regulatory expectations?
- Editable without audit trail
- Validated system with secure access and audit trail
- Only accessible via a shared password
- Stored on personal devices without backup
Correct Answer: Validated system with secure access and audit trail
Q8. Which item should be included on a sample label in the lab?
- Only the color of the sample
- Unique identifier, date, contents and initials of handler
- Laboratory address only
- Price of the reagents used
Correct Answer: Unique identifier, date, contents and initials of handler
Q9. Who is primarily responsible for maintaining accurate experiment records?
- The principal investigator alone
- The person who performed the experiment and the investigator
- Only the laboratory manager
- External auditors
Correct Answer: The person who performed the experiment and the investigator
Q10. What is the role of SOPs in record keeping?
- SOPs are optional and rarely followed
- SOPs provide standardized instructions for documentation and record retention
- SOPs replace the need for training
- SOPs are only for administrative staff
Correct Answer: SOPs provide standardized instructions for documentation and record retention
Q11. Which of the following best describes an audit trail?
- A list of experiments performed in the year
- A system-generated record of who made changes, when and why
- A copy of the final report only
- A checklist for daily tasks
Correct Answer: A system-generated record of who made changes, when and why
Q12. How should blank spaces in a laboratory notebook be handled?
- Left blank for future use
- Filled with doodles
- Crossed out with a line and initialled to prevent later insertion
- Erased later when needed
Correct Answer: Crossed out with a line and initialled to prevent later insertion
Q13. What is a major consequence of poor record keeping in pharmaceutical research?
- Improved regulatory relationships
- Data integrity issues and regulatory sanctions
- Automatic patent approval
- Increased reproducibility
Correct Answer: Data integrity issues and regulatory sanctions
Q14. For how long should experiment records generally be retained?
- Only until the experiment is finished
- As specified by regulatory guidelines and institutional policies
- One week
- Never retain paper records
Correct Answer: As specified by regulatory guidelines and institutional policies
Q15. What information is important in a batch record?
- Names of snacks consumed by staff
- Detailed steps, materials, equipment, measurements, signatures and deviations
- Only the final product weight
- Only vendor invoices
Correct Answer: Detailed steps, materials, equipment, measurements, signatures and deviations
Q16. Which practice supports chain of custody for samples?
- Allowing anyone to handle samples without documentation
- Documenting transfers with dated signatures and sample IDs
- Labeling samples with vague descriptions
- Storing samples without logs
Correct Answer: Documenting transfers with dated signatures and sample IDs
Q17. What is required when recording instrument-generated data electronically?
- Only saving a screenshot without metadata
- Preserving original files with metadata and validated software
- Transcribing results manually without verification
- Deleting raw files after printing
Correct Answer: Preserving original files with metadata and validated software
Q18. When deviations occur during an experiment, what must be documented?
- Only the final result
- Nature of deviation, impact assessment and corrective actions
- Nothing, if the experiment still worked
- Only verbal notes among staff
Correct Answer: Nature of deviation, impact assessment and corrective actions
Q19. Which element is critical for electronic signature compliance?
- Signatures shared among users
- Unique, verifiable user credentials and traceable action
- Handwritten signature pasted into a file
- Using generic login names
Correct Answer: Unique, verifiable user credentials and traceable action
Q20. What should a validated document control system provide?
- Version control, access restrictions and change history
- Only a filename without versioning
- Unlimited public editing
- Manual backups only
Correct Answer: Version control, access restrictions and change history
Q21. Which is an appropriate way to archive physical lab records?
- Store in damp, unlabelled boxes
- Use organized, labeled, secure storage with controlled access
- Leave records on benches
- Throw them away immediately after use
Correct Answer: Use organized, labeled, secure storage with controlled access
Q22. Why are training records important in record keeping?
- They show staff skills and authorization for tasks and record handling
- They are optional decoration
- They replace SOPs
- They are only for HR payroll
Correct Answer: They show staff skills and authorization for tasks and record handling
Q23. What is the best practice for recording units and significant figures?
- Omit units to save space
- Always include correct units and appropriate significant figures
- Use random units
- Never round numbers
Correct Answer: Always include correct units and appropriate significant figures
Q24. Which action demonstrates data integrity in electronic systems?
- Altering timestamps to match reports
- Maintaining original files, audit trails and controlled edits
- Allowing anonymous edits
- Deleting old audit logs
Correct Answer: Maintaining original files, audit trails and controlled edits
Q25. What should be included in an instrument logbook?
- Only the instrument purchase invoice
- Calibration, maintenance, usage, errors and operator initials
- Personal messages among staff
- Only the list of instruments available
Correct Answer: Calibration, maintenance, usage, errors and operator initials
Q26. During an inspection, what records are inspectors most likely to request?
- Personal diaries of staff
- Raw data, SOPs, training records, batch records and deviation logs
- Only the lab coat sizes
- Only financial statements
Correct Answer: Raw data, SOPs, training records, batch records and deviation logs
Q27. How should confidential patient or proprietary data be handled in records?
- Published openly online
- Protected by access controls and anonymization where applicable
- Left on shared desktop screens
- Sent via public email lists
Correct Answer: Protected by access controls and anonymization where applicable
Q28. What is an appropriate action when an instrument shows out-of-specification results?
- Ignore and continue experiments
- Stop, document results, investigate root cause and record corrective actions
- Delete the data
- Hide the result from supervisors
Correct Answer: Stop, document results, investigate root cause and record corrective actions
Q29. What does “traceability” in record keeping mean?
- Ability to trace connections between data, samples, procedures and personnel
- Tracking only the lab address
- Hiding sample origins intentionally
- Using vague identifiers
Correct Answer: Ability to trace connections between data, samples, procedures and personnel
Q30. Which practice enhances reproducibility of experiments through record keeping?
- Recording vague parameters like “room temperature” without values
- Detailed documentation of methods, reagent lot numbers, conditions and instrument settings
- Relying on memory for key steps
- Only noting successful outcomes
Correct Answer: Detailed documentation of methods, reagent lot numbers, conditions and instrument settings
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