1.0 OBJECTIVE:
1.1 This SOP shall describe the procedure for implementation and control of First In First Out (FIFO) and First Expiry First Out (FEFO) principles to ensure proper material rotation, prevent use of expired materials, and maintain product quality.
2.0 SCOPE:
2.1 This SOP shall be applicable to:
2.1.1 Raw materials
2.1.2 Packaging materials
2.1.3 Finished goods
2.2 stored and handled in:
2.2.1 Raw Material Warehouse
2.2.2 Packaging Material Warehouse
2.2.3 Finished Goods Warehouse
3.0 RESPONSIBILITIES:
3.1 Warehouse In-Charge shall ensure effective implementation of FIFO and FEFO.
3.2 Stores Personnel shall follow FIFO/FEFO during storage and issuance.
3.3 Quality Assurance (QA) shall monitor compliance and handle deviations.
4.0 DEFINATIONS:
4.1 First In First Out (FIFO): FIFO is a system in which materials or goods that are received first shall be issued or used first, irrespective of expiry date, provided the material is within its approved shelf life.
4.2 First Expiry First Out (FEFO): FEFO is a system in which materials or goods with the earliest expiry date shall be issued or used first, regardless of the date of receipt.
5.0 PROCEDURE:
5.1 General Requirements:
5.1.1 FIFO and FEFO principles shall be applied to all applicable materials and finished goods.
5.1.2 Material status shall be Approved before issuance.
5.1.3 Expired materials or goods shall not be issued under any circumstances.
5.2 FIFO and FEFO:
5.2.1 The First In First Out (FIFO) principle shall be the primary material rotation system followed in all warehouses.
5.2.2 Materials and finished goods shall normally be issued in the order of date of receipt, provided they are within their approved shelf life.
5.2.3 In situations where materials or goods received later have a shorter remaining shelf life compared to existing stock, priority shall be given based on expiry date to prevent the risk of expiry.
5.2.4 In such cases, materials with the earliest expiry date shall be issued first, even if they were received later than existing stock.
5.2.5 This expiry-based prioritization shall be applied as a risk-based control measure and shall not replace FIFO as the standard system.
5.2.6 Expired materials or goods shall not be issued under any circumstances.
5.3 Labeling and Identification:
5.3.1 Each container, pallet, or shipper shall display:
5.3.1.1 Batch / Lot number
5.3.1.2 Date of receipt
5.3.1.3 Expiry date (where applicable)
5.3.2 Status labels shall be clearly visible to support FIFO / FEFO decisions.
5.4 Issuance of Materials and Finished Goods:
5.4.1 Issuance shall be done only from QA-approved stock.
5.4.2 Stores personnel shall verify the status like Batch / Lot number and Expiry date.
5.4.3 FIFO or FEFO compliance shall be ensured before issuance.
5.5 Handling of Near-Expiry Materials:
5.5.1 Materials approaching expiry shall be identified and reported to QA.
5.5.2 QA shall decide on like Priority usage, Re-testing (if applicable) and Rejection or disposal
5.6 Monitoring and Verification:
5.6.1 Warehouse In-Charge shall periodically verify FIFO and FEFO compliance.
5.6.2 Any deviation shall be immediately reported to QA.
5.6.3 QA shall assess the impact and initiate CAPA where required.
5.6.4 Any non-compliance with FIFO or FEFO shall be documented as a deviation.
5.7 Training:
5.7.1 Warehouse personnel shall be trained on FIFO and FEFO principles.
5.7.2 Training records shall be maintained.
6.0 REFERENCE:
6.1 WHO TRS 961, Annex 2
6.2 WHO Good Storage Practices
6.3 EU-GMP Part I, Chapter 3 & Chapter 5
7.0 RECORDS:
Sr No. Title Document No.
NA NA NA
8.0 REVISION HISTORY:
Amendment Date: Update Summary Version No.
NA New SOP 01