1.0 OBJECTIVE:
1.1 This SOP shall describe the procedure for status labeling and identification of materials and finished goods to ensure clear identification, prevent mix-ups, and maintain traceability throughout warehouse operations.

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 in Raw Material Warehouse, Packaging Material Warehouse, and Finished Goods Warehouse.

3.0 RESPONSIBILITIES:
3.1 Warehouse In-Charge shall ensure correct labeling and segregation of materials.

3.2 Stores Personnel shall affix and maintain status labels as per this SOP.

3.3 Quality Assurance (QA) shall authorize status changes and verify labeling accuracy.

4.0 DEFINATIONS:
4.1 Status Label: A status label is a controlled label affixed to materials or finished goods to indicate their quality status and authorization for use or distribution.

4.2 Identification Label: An identification label is a label that provides essential information to uniquely identify materials or finished goods.

5.0 PROCEDURE:
5.1 General Requirements:
5.1.1 All materials and finished goods shall be clearly and legibly labeled at all times.
5.1.2 Labels shall be affixed in a visible location on each container, pallet, or shipper.

5.1.3 Handwritten labels shall be made using indelible ink.

5.1.4 Overwriting or erasing on labels shall not be permitted.

5.2 Types of Status Labels
5.2.1 The following status labels shall be used in warehouse areas:
Status Label Color Description
Quarantine Yellow Materials or goods awaiting QC sampling
Approved Green Materials or goods released by QC
Rejected Red Materials or goods not meeting specifications
Returned Orange Returned from production or market
Recalled Red (Bold) Goods recalled from market

5.3 Status Labeling at Receipt:
5.3.1 Upon receipt, all materials and finished goods shall be labeled as “QUARANTINE.”

5.3.2 Quarantine labels shall be affixed immediately after receipt and before storage.

5.3.3 Materials without proper status labels shall not be stored or issued.

5.4 Status Change and Authorization:
5.4.1 Status labels shall be changed only after written authorization from QA.

5.4.2 Previous status labels shall be removed or defaced in a manner that prevents misuse.

5.4.3 Status change shall be recorded in the relevant warehouse records.

5.5 Identification Details on Labels:
5.5.1 Each status label shall contain, at a minimum, the following information:
5.5.1.1 For Raw Materials / Packaging Materials
5.5.1.1.1 Material Name
5.5.1.1.2 Material Code
5.5.1.1.3 Batch / Lot Number
5.5.1.1.4 Quantity
5.5.1.1.5 Status
5.5.1.1.6 Date
5.5.1.1.7 Signature / Initials

5.5.1.2 For Finished Goods
5.5.1.2.1 Product Name
5.5.1.2.2 Strength
5.5.1.2.3 Batch Number
5.5.1.2.4 Pack Size
5.5.1.2.5 Quantity
5.5.1.2.6 Status
5.5.1.2.7 Date
5.5.1.2.8 Signature / Initials

5.6 Segregation Based on Status:
5.6.1 Materials and finished goods shall be physically segregated based on status.

5.6.2 Approved, rejected, and quarantine materials shall not be stored together.

5.6.3 Rejected and recalled materials shall be stored in locked and restricted areas.

5.7 Handling of Partially Used Containers:
5.7.1 Partially used containers shall be resealed and relabeled.

5.7.2 Updated quantity and date shall be recorded on the identification label.
5.7.3 Partially used containers shall retain their original status unless changed by QA.

5.8 Handling of Illegible or Damaged Labels:
5.8.1 Illegible or damaged labels shall be replaced immediately.

5.8.2 Replacement labels shall be issued with QA knowledge.

5.8.3 Traceability shall be ensured before relabelling.

5.9 Deviation:
5.9.1 Any deviation from this SOP shall be documented and investigated.

5.9.2 QA shall assess the impact and decide appropriate CAPA.

5.10 Training:
5.10.1 All warehouse personnel shall be trained on this SOP.

5.10.2 Training records shall be maintained.

6.0 REFERENCE:
6.1 WHO TRS 961, Annex 2 and WHO Good Storage Practices

6.2 EU-GMP Part I, Chapter 3 & Chapter 5

7.0 RECORDS:
Sr No. Title Document No.

8.0 REVISION HISTORY:
Amendment Date: Update Summary Version No.
NA New SOP 01