Certified Pharmaceutical GMP Professional Practice

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Study for the Certified Pharmaceutical GMP Professional Exam. Prepare with comprehensive quizzes and detailed explanations to boost your understanding and confidence. Ready yourself for certification!

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What is necessary for an acceptable component inventory record?

  1. Comparison with previous year's usage

  2. A detailed list of all approved suppliers

  3. Reconciliation of use of each lot

  4. Observations of manufacturing plants

The correct answer is: Reconciliation of use of each lot

An acceptable component inventory record must include reconciliation of use of each lot to ensure that the quantities on hand match the quantities used throughout the production process. This reconciliation is crucial for maintaining accurate inventory levels, which directly impacts production planning and compliance with Good Manufacturing Practices (GMP). By tracking each lot's usage, discrepancies can be identified and addressed, thus ensuring that all components can be traced back to their origins, which is essential for quality assurance and regulatory compliance. While comparing with previous year's usage, having a detailed list of approved suppliers, and observations of manufacturing plants may be useful in broader inventory management or quality assurance practices, they do not specifically address the critical need for lot-specific tracking and accountability. Reconciliation provides a high level of visibility into how each component is utilized, ensuring that tracking, recall, and traceability requirements are met under GMP standards.