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Questions and Answers
Who is responsible for implementing the procedure outlined in the text?
Who is responsible for implementing the procedure outlined in the text?
Which SOP is referenced for the receipt of finished drug product?
Which SOP is referenced for the receipt of finished drug product?
What is the purpose of the procedure outlined in the text?
What is the purpose of the procedure outlined in the text?
Who is responsible for correcting inventory in the ERP system by issuing credit notes or invoices to the customer?
Who is responsible for correcting inventory in the ERP system by issuing credit notes or invoices to the customer?
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What is the scope of the SOP outlined in the text?
What is the scope of the SOP outlined in the text?
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What is the main purpose of the ASRS inventory cycle count?
What is the main purpose of the ASRS inventory cycle count?
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What does LPN stand for in the context of the given text?
What does LPN stand for in the context of the given text?
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When is a 100% cycle count of Module 1 performed?
When is a 100% cycle count of Module 1 performed?
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What should be done after completing the physical cycle count in ASRS?
What should be done after completing the physical cycle count in ASRS?
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What is the frequency for Inventory Cycle for Finished Drug Products for Non ASRS Inventory cycle count?
What is the frequency for Inventory Cycle for Finished Drug Products for Non ASRS Inventory cycle count?
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What is the frequency for the ASRS inventory cycle count as per the text?
What is the frequency for the ASRS inventory cycle count as per the text?
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What does LPN stand for in the context of the given text?
What does LPN stand for in the context of the given text?
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What is the purpose of the WMS in the context of the text?
What is the purpose of the WMS in the context of the text?
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What is the frequency for Non ASRS Inventory cycle count for finished drug products as per the text?
What is the frequency for Non ASRS Inventory cycle count for finished drug products as per the text?
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What is the purpose of Fast Moving Products or Key Products in the context of the given text?
What is the purpose of Fast Moving Products or Key Products in the context of the given text?
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Who is responsible for verifying any discrepancy after reviewing the investigation report for the discrepancy and advising for any adjustment?
Who is responsible for verifying any discrepancy after reviewing the investigation report for the discrepancy and advising for any adjustment?
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What is the purpose of the SOP referenced as SOP- DC013?
What is the purpose of the SOP referenced as SOP- DC013?
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In the context of the given text, who is responsible for implementing the procedure?
In the context of the given text, who is responsible for implementing the procedure?
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What is the main purpose of 21 CFR Part 211.180 referenced in the text?
What is the main purpose of 21 CFR Part 211.180 referenced in the text?
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What is the frequency for Inventory Cycle for Finished Drug Products for Non ASRS Inventory cycle count?
What is the frequency for Inventory Cycle for Finished Drug Products for Non ASRS Inventory cycle count?
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Study Notes
Responsible Parties
- The Quality Assurance (QA) department is responsible for implementing the procedure outlined in the text.
Standard Operating Procedures (SOPs)
- SOP-DC013 is referenced for the receipt of finished drug product.
Purpose of the Procedure
- The purpose of the procedure is to ensure accurate inventory management and compliance with regulatory requirements.
Inventory Management
- The Customer Service department is responsible for correcting inventory in the ERP system by issuing credit notes or invoices to the customer.
Scope of the SOP
- The SOP outlined in the text applies to finished drug products stored in both ASRS (Automated Storage and Retrieval System) and non-ASRS inventory.
ASRS Inventory Cycle Count
- The main purpose of the ASRS inventory cycle count is to verify inventory accuracy.
- LPN stands for License Plate Number in the context of the given text.
- A 100% cycle count of Module 1 is performed quarterly.
- After completing the physical cycle count in ASRS, discrepancies are investigated, and adjustments are made as necessary.
Inventory Cycle Count Frequencies
- The frequency for the ASRS inventory cycle count is quarterly.
- The frequency for Non-ASRS Inventory cycle count for finished drug products is semi-annually.
Warehouse Management System (WMS)
- The purpose of the WMS is to manage and track inventory in real-time.
Fast Moving Products or Key Products
- The purpose of Fast Moving Products or Key Products is to identify high-priority items for inventory management.
Discrepancy Resolution
- The QA department is responsible for verifying any discrepancy after reviewing the investigation report and advising for any adjustment.
Regulatory Compliance
- The main purpose of 21 CFR Part 211.180 referenced in the text is to ensure compliance with FDA regulations for drug product storage and inventory management.
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Description
Learn about the procedures and responsibilities for maintaining accurate records and inventory of finished drug products at the Aurobindo Pharma, NJ Facility.
