SQA Study Guide 2026
Everything you need to pass the SQA exam in one place: the exam format, every topic to study, real practice questions with explanations, flashcards, and full-length practice tests. Free, no sign-up needed.
📋 SQA Exam Format at a Glance
📚 SQA Topics to Study (48)
✍️ Sample SQA Questions & Answers
1. What is a 'remote audit' or 'desk audit' in pharmaceutical quality assurance?
A remote audit reviews quality records, procedures, and data submitted electronically, enabling some level of quality oversight without requiring an on-site visit.
2. What is the key principle behind 'mistake-proofing' (poka-yoke) in quality management?
Poka-yoke devices or methods physically prevent errors or immediately alert operators to mistakes, reducing reliance on human vigilance.
3. In GLP auditing, what is the purpose of a retrospective data audit?
Retrospective data audits review completed study records to assess data integrity and GLP compliance of the documented study conduct.
4. Which type of audit evaluates a supplier's quality system from a customer's perspective?
A second-party audit is conducted by a customer or their representative to assess a supplier's quality management system.
5. What is the purpose of 'worst-case' testing in equipment or process validation?
Worst-case testing challenges the process or equipment at boundary conditions most likely to result in failure, providing confidence that routine operations will always succeed.
6. What is a 'process audit' in the context of GLP quality assurance?
A process audit examines how a specific work process (e.g., sample processing, data recording) is performed compared to written procedures.