Audit Checklist for Store Department

An audit checklist for the store department in pharmaceuticals is a tool used by auditors to systematically evaluate the performance and compliance of the store department of a pharmaceutical company with applicable laws, regulations, standards, and best practices.

The store department in a pharmaceutical company plays a critical role in ensuring that the right raw materials, packaging materials, finished goods, and other supplies are procured, received, stored, and issued in a timely and accurate manner to support the manufacturing and distribution operations of the company. The store department also has to ensure that the inventory levels are maintained at optimal levels to avoid stockouts, wastage, or expiry of products.

An audit checklist for the store department in pharmaceuticals typically includes the following areas:

1. Physical infrastructure: The auditor will evaluate the physical condition and layout of the store department, including its cleanliness, lighting, ventilation, temperature control, pest control, fire safety, and security measures.
2. Inventory management: The auditor will examine the procedures and controls in place for inventory management, including stock receipts, storage, issuance, reconciliation, and disposal. The auditor will also review the accuracy and completeness of inventory records, such as stock cards, stock ledgers, and inventory reports.
3. Quality control: The auditor will evaluate the quality control measures in place for incoming raw materials, packaging materials, finished products, and other supplies. The auditor will also review the sampling, testing, and release procedures for these items.
4. Documentation and record-keeping: The auditor will examine the documentation and record-keeping practices of the store department, including the filing, retention, and retrieval of documents related to inventory management, quality control, and other operations.
5. Compliance: The auditor will assess the store department's compliance with applicable laws, regulations, and standards, such as Good Manufacturing Practices (GMP), Good Storage Practices (GSP), and Good Distribution Practices (GDP). The auditor will also review the store department's adherence to internal policies, procedures, and guidelines.
6. Training and competency: The auditor will evaluate the training and competency levels of the store department's personnel, including their understanding of inventory management, quality control, documentation, and compliance requirements.
7. Continuous improvement: The auditor will assess the store department's continuous improvement initiatives, such as root cause analysis, corrective actions, preventive actions, and management review.

Overall, an audit checklist for the store department in pharmaceuticals is a comprehensive tool that helps auditors to systematically evaluate the performance and compliance of the store department in a pharmaceutical company. The checklist provides a structured approach for auditors to identify gaps, deficiencies, and opportunities for improvement, and to make recommendations for corrective actions to enhance the effectiveness and efficiency of the store department's operations.

ALSO READ: Data Integrity Checklist for Pharmaceutical Industry

Sr. No.	Checkpoints	Observation	Recommendation	Action taken by
01	Is the control copy of store department SOPs available?
02	Is the person having knowledge of current GMP requirements?
03	Is the incoming raw materials entry register available?
04	Is the housekeeping maintained?
05	Is the sampling booth area cleaned?
06	Is the weighting balance having proper tag of calibration status?
07	Is the balance calibration record available?
08	Are the calibrated standard weights available?
09	Is the calibration certificate available?
10	Is the standard weights are properly stored?
11	Is the quarantine, approved and rejected area designated?
12	Are the UNDER-TEST label pasted on all the incoming raw materials?
13	Are the SAMPLE label pasted on all the sampled raw materials?
14	Are the APPROVED labels pasted on all the approved raw materials?
15	Are the raw materials stored at their respective place?
16	Check the cleaning and housekeeping condition record of quarantine, approved and rejected area.
17	Are the packing materials stored separately?
18	Is the cleaning and housekeeping maintained at packing material store area?
19	Is the temperature and relative humidity record maintained for all respective area?
20	Is the approved vendor list available?
21	Is the FIFO system follow?
22	Check the production requisition slip record?
23	Check the issuance record.
24	Check the dispatch record.
25	Check the general cleaning and housekeeping of the store.
26	Check the personnel hygiene.
27	Check the safety equipments.
28	Check the drum storage yard for cleaning, housekeeping and status.
29	Check the proper segregation at drum storage yard?
30	Check the other records.
31	Is line clearance activity performed?

ALSO READ: Audit Checklist for Data Integrity