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(Top 50 IPQA Interview Questions and Answers) |
In-Process Quality Assurance (IPQA) is one of the most important roles in pharmaceutical manufacturing. Whether you are a B.Pharm fresher, M.Pharm graduate, or an experienced QA professional, cracking an IPQA interview requires strong knowledge of GMP, documentation, deviations, BMR, audits, and compliance.
In this article, Pharma Duniya brings you the Top 50 IPQA Interview Questions and Answers, specially designed for pharma company interviews. These questions are commonly asked in tablet, capsule, injectable, syrup, API, and OSD manufacturing plants.
IPQA (In-Process Quality Assurance) ensures that pharmaceutical manufacturing activities are carried out as per approved procedures, GMP guidelines, and regulatory requirements during production and packing.
IPQA acts as a bridge between production and quality.
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IPQA stands for In-Process Quality Assurance. It ensures that manufacturing and packing processes comply with GMP and approved procedures during operations.
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IPQA monitors in-process activities, performs line clearance, checks BMR entries, handles deviations, and ensures GMP compliance.
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QA is a broad quality system, while IPQA specifically focuses on shop-floor activities during manufacturing and packing.
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Line clearance ensures that the production or packing area is free from previous product, documents, and materials before starting a new batch.
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It prevents mix-ups, cross-contamination, and documentation errors, ensuring patient safety.
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BMR (Batch Manufacturing Record) is a controlled document that records complete manufacturing details of a batch.
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BPR (Batch Packing Record) records all activities related to packing of the finished product.
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GMP (Good Manufacturing Practices) are guidelines ensuring consistent product quality and safety.
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Deviation is any departure from approved procedures, specifications, or standards.
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CAPA stands for Corrective and Preventive Action to prevent recurrence of deviations.
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A documented system to manage changes in process, equipment, material, or documents.
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Checks performed during manufacturing like weight variation, hardness, thickness, pH, fill volume, etc.
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Yield is the ratio of actual output to theoretical output.
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Verification of issued, used, rejected, and returned quantities of materials.
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SOP (Standard Operating Procedure) gives step-by-step instructions to perform activities consistently.
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Unintended contamination of one product with another product or material.
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Data Integrity ensures data is ALCOA+ compliant (Attributable, Legible, Contemporaneous, Original, Accurate).
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ALCOA stands for Attributable, Legible, Contemporaneous, Original, Accurate.
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Study to establish maximum holding time for materials or intermediates without quality impact.
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Material rejected during manufacturing due to non-compliance.
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Out of Specification result during testing.
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Out of Trend result that shows abnormal trend though within specification.
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Collection of samples during manufacturing or packing for QC testing.
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Monitoring of temperature, humidity, and microbiological conditions.
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Systematic examination to ensure GMP compliance.
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United States Food and Drug Administration regulates drugs for the US market.
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Guidelines issued by WHO for pharmaceutical manufacturing quality.
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QA approval to release a batch after reviewing all documents.
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Parameter that directly affects product quality.
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Graphical representation of process performance.
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Supporting document attached to SOP or record.
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Ability to trace materials from receipt to final product.
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Training to educate employees about GMP practices.
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Evaluation of potential risks to product quality.
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Failure Mode and Effects Analysis used in risk management.
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Documented evidence that process consistently produces quality product.
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Maintaining cleanliness and organization of production area.
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Verification of issued, used, and destroyed labels.
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QA supervision over manufacturing activities.
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Evaluation of effect of change on quality, safety, and compliance.
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Record of equipment usage and cleaning.
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Non-compliance with GMP guidelines.
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QA presence directly on manufacturing floor.
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Deviation with direct impact on product quality or patient safety.
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BMR, BPR, SOPs, logbooks, deviation reports.
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Because IPQA allows hands-on involvement in manufacturing quality and GMP compliance.
IPQA is a high-responsibility and high-growth role in pharmaceutical companies. Preparing these Top 50 IPQA Interview Questions and Answers will significantly increase your chances of cracking QA/IPQA interviews in leading pharma companies.
Stay consistent, revise GMP concepts, and always focus on quality mindset.
Note: Pharma Duniya does not charge any money for job information.
Candidates are advised to verify details from the official company website.
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