Specifications, protocols and test procedures MCQs With Answer

Introduction: This collection of MCQs on Specifications, Protocols and Test Procedures is designed for M.Pharm students specializing in Quality Control and Quality Assurance. The questions emphasize practical regulatory expectations, analytical method requirements, and procedural controls used in pharmaceutical QC laboratories. Topics covered include specification setting, protocol components, analytical validation parameters, system suitability, method transfer, stability testing, out-of-specification investigations, and data integrity. Each question is framed to build conceptual depth and application skills necessary for preparing, executing and reviewing QC documentation and results. Use these MCQs to test understanding, prepare for viva/boards, and reinforce best laboratory practices in pharmaceutical quality assurance.

Q1. Which statement best describes the primary purpose of product specifications in QC?

• Provide manufacturing instructions for the production team
• Define acceptance criteria and analytical methods for product release and shelf-life
• List equipment calibration schedules only
• Serve as marketing claims for product promotion

Correct Answer: Define acceptance criteria and analytical methods for product release and shelf-life

Q2. Which documented procedure is specifically used to manage and investigate results that fall outside established acceptance criteria?

• Change control procedure
• Out-of-specification (OOS) investigation procedure
• Calibration procedure
• Stability study protocol

Correct Answer: Out-of-specification (OOS) investigation procedure

Q3. According to ICH Q2(R1), which of the following is NOT a formal validation parameter for an analytical procedure?

• Specificity
• Accuracy
• Risk assessment
• Robustness

Correct Answer: Risk assessment

Q4. System suitability tests in chromatographic assays are primarily intended to assess:

• The therapeutic efficacy of the drug substance
• The performance of the analytical system and method prior to sample analysis
• The sterility of the finished dosage form
• The supplier qualification status

Correct Answer: The performance of the analytical system and method prior to sample analysis

Q5. A stability-indicating method is defined as an analytical procedure that:

• Measures only the API in pure form
• Can separate and quantify the active pharmaceutical ingredient in presence of its degradation products
• Is used only for microbiological testing
• Requires no validation

Correct Answer: Can separate and quantify the active pharmaceutical ingredient in presence of its degradation products

Q6. How do release specifications differ from shelf-life (storage) specifications?

• They are identical and never change
• Release specifications relate to initial batch release; shelf-life specifications include limits accounting for product degradation over time
• Release specifications are only for raw materials
• Shelf-life specifications are only concerned with packaging appearance

Correct Answer: Release specifications relate to initial batch release; shelf-life specifications include limits accounting for product degradation over time

Q7. Which of the following is essential content in a written test procedure used by a QC laboratory?

• Supplier financial statements
• Detailed stepwise instructions, reagent preparations, and acceptance criteria
• Marketing strategy for the product
• Only the instrument model number

Correct Answer: Detailed stepwise instructions, reagent preparations, and acceptance criteria

Q8. When collecting samples for QC testing, the sample must be:

• Representative of the lot or batch
• Selected for convenience from the front of the shelf
• Only taken from the last produced unit
• Chosen based on visual appeal

Correct Answer: Representative of the lot or batch

Q9. Which international guideline is most commonly cited for establishing pharmaceutical specifications?

• ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and Products
• Good Distribution Practice (GDP)
• ISO 9001
• ICH Q7: Good Manufacturing Practice for Active Pharmaceutical Ingredients

Correct Answer: ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and Products

Q10. What is the main difference between a limit test and a quantitative assay?

• A limit test measures the exact potency of the API
• A quantitative assay detects presence only; a limit test provides exact percentage
• A limit test checks whether an impurity or attribute is below a specified threshold, whereas an assay measures the precise amount of the analyte
• There is no difference

Correct Answer: A limit test checks whether an impurity or attribute is below a specified threshold, whereas an assay measures the precise amount of the analyte

Q11. In QA/QC documentation, SOP stands for:

• Standard Operating Procedure
• Statistical Operating Plan
• Sample Optimization Protocol
• Supplier Oversight Program

Correct Answer: Standard Operating Procedure

Q12. The primary objective of analytical method transfer between laboratories is to:

• Replace the original method with a different unvalidated method
• Ensure the receiving laboratory can perform the method and obtain equivalent, reproducible results
• Reduce the number of QC analysts
• Eliminate system suitability requirements

Correct Answer: Ensure the receiving laboratory can perform the method and obtain equivalent, reproducible results

Q13. In chromatography system suitability, the Relative Standard Deviation (RSD) of replicate injections primarily assesses:

• Resolution between peaks
• Precision of the analytical system
• Accuracy of the assay
• Limit of detection

Correct Answer: Precision of the analytical system

Q14. Which stability study is most important when assigning an official shelf-life under labeled storage conditions?

• Accelerated stress testing only
• Long-term (real-time) stability studies conducted under recommended storage conditions
• Forced degradation under extreme conditions only
• Packaging compatibility studies only

Correct Answer: Long-term (real-time) stability studies conducted under recommended storage conditions

Q15. For quantifying low-level impurities with acceptable precision and accuracy, which validation parameter is most appropriate?

• Limit of Detection (LOD)
• Limit of Quantitation (LOQ)
• Linearity range maximum only
• Tailing factor

Correct Answer: Limit of Quantitation (LOQ)

Q16. Trend analysis of QC data is used primarily to:

• Automatically release batches without review
• Detect small shifts or drifts in quality attributes before they become out-of-specification events
• Determine marketing strategies
• Replace periodic calibration

Correct Answer: Detect small shifts or drifts in quality attributes before they become out-of-specification events

Q17. Which elements should be included in a protocol for a new analytical test procedure?

• Objective, scope, detailed procedure, acceptance criteria, and responsibilities
• Only the title and the analyst name
• Financial costs and supplier discounts
• The marketing approval letter

Correct Answer: Objective, scope, detailed procedure, acceptance criteria, and responsibilities

Q18. If a routine QC test yields an out-of-specification result, the immediate correct action is to:

• Release the batch if most tests pass
• Hold the affected batch and initiate an OOS investigation per procedure
• Discard the record and repeat the test without documentation
• Adjust the specification limits to include the result

Correct Answer: Hold the affected batch and initiate an OOS investigation per procedure

Q19. In cleaning validation protocols, which acceptance criterion is most scientifically justified for defining acceptable residue on manufacturing equipment?

• Visual cleanliness alone
• Acceptance limits based on a toxicological risk assessment or clinically relevant exposure limits
• Arbitrary limits chosen by production staff
• Using the highest detectable amount as acceptable

Correct Answer: Acceptance limits based on a toxicological risk assessment or clinically relevant exposure limits

Q20. Which practice best supports data integrity within QC test procedures?

• Allowing unsigned manual corrections to expedite release
• Following ALCOA-C principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete)
• Keeping raw data offsite without traceability
• Using undocumented shortcuts during testing

Correct Answer: Following ALCOA-C principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete)

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