Handling and Storage of Procured Goods – Standard Operating Procedure
1) Purpose
To establish a standardized process for the proper handling and storage of procured goods to ensure their quality, safety, and compliance with regulatory requirements within the pharmaceutical purchase department.
2) Scope
This SOP applies to all procured goods, including raw materials, packaging materials, laboratory supplies, and manufacturing equipment, from receipt through storage within the pharmaceutical purchase department.
3) Responsibilities
Warehouse Manager: Responsible for overseeing the handling and storage processes and ensuring compliance with SOPs.
Warehouse Staff: Responsible for implementing handling and storage procedures and maintaining records.
Quality Control (QC) Team: Responsible for inspecting procured goods upon receipt and during storage.
4) Procedure
4.1) Receiving Goods:
4.1.1) Verify that the goods received match the purchase order specifications, including quantity, type, and condition.
4.1.2) Inspect the goods for any visible damage or discrepancies and document findings.
4.1.3) Inform the QC team to perform further inspections and quality checks as required.
4.2) Unloading and Handling:
4.2.1) Use appropriate equipment (e.g., forklifts, hand trucks) to unload goods safely and efficiently.
4.2.2) Follow proper handling procedures to prevent damage, contamination,
4.2.3) Label goods with relevant information, such as batch numbers, expiration dates, and storage requirements.
4.3) Storage Conditions:
4.3.1) Store goods in designated areas according to their specific storage requirements (e.g., temperature, humidity, light exposure).
4.3.2) Ensure that storage areas are clean, organized, and free from contaminants.
4.3.3) Implement a system for tracking the location and status of all stored goods.
4.4) Inventory Management:
4.4.1) Maintain accurate inventory records, including quantities, locations, and expiration dates of stored goods.
4.4.2) Conduct regular inventory audits to verify accuracy and identify any discrepancies.
4.4.3) Use a first-in, first-out (FIFO) system to manage the rotation of goods and prevent expiration.
4.5) Monitoring and Maintenance:
4.5.1) Monitor storage conditions regularly to ensure they remain within specified limits.
4.5.2) Perform routine maintenance of storage facilities and equipment to ensure they are in good working order.
4.5.3) Address any deviations from specified storage conditions promptly to prevent adverse effects on the goods.
4.6) Handling of Non-Conforming Goods:
4.6.1) Identify and segregate any goods that do not meet quality standards or have been damaged.
4.6.2) Document non-conformities and notify the appropriate personnel for further action.
4.6.3) Follow procedures for the disposal or return of non-conforming goods.
4.7) Documentation and Record Keeping:
4.7.1) Maintain detailed records of all handling and storage activities, including inspections, inventory logs, and maintenance records.
4.7.2) Ensure documentation is complete, accurate, and readily available for audits and future reference.
5) Abbreviations, if any
- QC: Quality Control
- FIFO: First-In, First-Out
6) Documents, if any
- Receiving Reports
- Inspection Checklists
- Inventory Logs
- Maintenance Records
- Non-Conformance Reports
7) Reference, if any
Regulatory Guidelines: FDA CFR Part 211, ISO 9001:2015
Industry Standards: Best practices in handling and storage of pharmaceutical goods
8) SOP Version
Version 1.0