QMS in Pharmaceutical industry l Quality Management system in Pharmaceutical Industry l Question and answers
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Questions covered:
Q. What is a Quality Management System (QMS) ?
Q. What are the key elements of a QMS in the pharmaceutical sector ?
Q. How does a pharmaceutical QMS ensure compliance with regulatory requirements ?
Q. Explain the concept of risk management in QMS ?
Q. What role does validation play in pharmaceutical QMS ?
Q. How is change control implemented in a pharmaceutical QMS ?
Q. What is the purpose of a Master Validation Plan (MVP) in QMS ?
Q. Explain the significance of Good Documentation Practices (GDP) in QMS ?
Q : Which are the advance investigation tools commonly used in Pharmaceutical industry?
Q. Explain the purpose of a Quality Risk Management (QRM) process in a pharmaceutical QMS ?
Q. What is the difference between corrective action and preventive action in QMS ?
Q : What are the major four types of validation ?
Q. How does a pharmaceutical QMS address deviations from standard operating procedures (SOPs)?
Q. Explain the concept of Critical Quality Attributes (CQAs) in the context of pharmaceutical QMS?
Q. How does a pharmaceutical QMS handle the qualification of equipment and utilities?
Q. Explain the concept of CAPA effectiveness checks in QMS?
Q. What is the role of a Document Control System in a pharmaceutical QMS?
Q. How does a pharmaceutical QMS address complaints and recalls ?
Q. Explain the concept of Change Management in QMS.
Q. What is the role of a Quality Risk Management Plan in pharmaceutical QMS?
Q. How does a pharmaceutical QMS ensure data integrity in electronic systems?
Q. Explain the concept of Continuous Process Verification (CPV) in a pharmaceutical QMS.
Q. What is the purpose of a Stability Program in the QMS of a pharmaceutical company ?
Q. What is the role of Key Performance Indicators (KPIs) in monitoring the effectiveness of a pharmaceutical QMS ?
Q: What is the role of Standard Operating Procedures (SOPs) in pharmaceutical quality system ?
Q: What is the role of Training in maintaining quality system ?
Q. What does ALCOA plus stand for in data integrity?
Q. What is Deviation?
Q : Which are the simple investigation tools commonly used in Pharmaceutical industry?
Q. How do you classify deviations?
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Keywords to find this video:
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