Aurobindo Pharma NJ Facility Inventory Management SOP

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Questions and Answers

Who is responsible for implementing the procedure outlined in the text?

Accounts payable manager/designee

QA Manager/designee

Distribution Center Associate

Distribution Center Sr. Director (correct)

Which SOP is referenced for the receipt of finished drug product?

SOP—CS808 Inventory cycle count for controlled substance finished drug product

SOP- QA805 Deviations planned and unplanned

SOP-DC013 Distribution of Finished Drug Product

SOP-DC004 Receipt of Finished Drug Product (correct)

What is the purpose of the procedure outlined in the text?

To ensure the correctness of physical inventory with the inventory in the ERP system (correct)

To handle deviations planned and unplanned

To receive finished drug products at the distribution center

To move pallets in a safe manner

Who is responsible for correcting inventory in the ERP system by issuing credit notes or invoices to the customer?

Accounts payable manager/designee Signup and view all the answers

What is the scope of the SOP outlined in the text?

Applies only at Aurobindo Pharma, NJ Facility Signup and view all the answers

What is the main purpose of the ASRS inventory cycle count?

To reconcile all physical discrepancies in the inventory Signup and view all the answers

What does LPN stand for in the context of the given text?

License Plate Number Signup and view all the answers

When is a 100% cycle count of Module 1 performed?

At the beginning of the first month of each quarter Signup and view all the answers

What should be done after completing the physical cycle count in ASRS?

Submit the inventory control team level-wise report to record entries into an excel file Signup and view all the answers

What is the frequency for Inventory Cycle for Finished Drug Products for Non ASRS Inventory cycle count?

Once per Month Signup and view all the answers

What is the frequency for the ASRS inventory cycle count as per the text?

Once per month Signup and view all the answers

What does LPN stand for in the context of the given text?

License Plate Number Signup and view all the answers

What is the purpose of the WMS in the context of the text?

Warehouse Management System Signup and view all the answers

What is the frequency for Non ASRS Inventory cycle count for finished drug products as per the text?

Once per month Signup and view all the answers

What is the purpose of Fast Moving Products or Key Products in the context of the given text?

Products which are shipped in more volume Signup and view all the answers

Who is responsible for verifying any discrepancy after reviewing the investigation report for the discrepancy and advising for any adjustment?

QA Manager/designee Signup and view all the answers

What is the purpose of the SOP referenced as SOP- DC013?

Distribution of Finished Drug Product Signup and view all the answers

In the context of the given text, who is responsible for implementing the procedure?

Distribution Center (DC) Sr. Director Signup and view all the answers

What is the main purpose of 21 CFR Part 211.180 referenced in the text?

Documenting procedures required for maintaining complete and accurate records of the finished drug product Signup and view all the answers

What is the frequency for Inventory Cycle for Finished Drug Products for Non ASRS Inventory cycle count?

100% cycle count quarterly Signup and view all the answers

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.