Learn how to prepare a SOP for Labeling of Raw and Packaging Materials in pharmaceuticals.
Table of Contents
1.0 PURPOSE
To set up the procedure for labeling & affixing labels to raw materials in the warehouse.
2.0 SCOPE
This SOP is applicable to all raw and Packaging materials in the warehouse.
3.0 RELATED DOCUMENTS
Nill
4.0 DEFINITIONS
Status label: Label that indicates the status of material or product like QUARANTINED, SAMPLED, UNDER TEST, PASSED, REJECTED etc.
5.0 PRECAUTIONS
5.1 Never use correction fluid for any mistake while preparing the label.
5.2 Never affix any status label to the lid of the container.
6.0 RESPONSIBILITIES
6.1 Officer Warehouse is responsible for preparing and affixing QUARANTINED LABEL
6.2 The sampler is responsible for preparing and affixing the SAMPLED LABEL and UNDERTEST LABEL.
6.3 QC Analyst is responsible for preparing and affixing the PASSED LABEL and the REJECTED LABEL.
Read Also: SOP for Dress Changing Procedure of Personnel in Warehouse
7.0 ACCOUNTABILITY
Head of Department
8.0 PROCEDURE
8.1 Fill up the contents for status labels legibly and correctly. If there is a mistake, write it down, sign with the date and write the correct information legibly or tear the label and prepare a new one. Do not overwrite any letter while writing labels.
8.2 Affix the QUARANTINED label after checking and receiving the raw material containers. Affix them beside the original label of each container so that those can easily be read.
8.3 Affix SAMPLED LABEL on the sample container only.
8.4 Affix UNDER TEST label on each and every container.
8.5 Affix PASSED / REJECTED label after completion of analysis.
8.6 Ensure that all labels are affixed in a cascading manner (Annexure-1)
9.0 ABBREVIATIONS
9.1 SOP: Standard Operating Procedure
9.2 QC: Quality Control
10.0 ANNEXURES
10.1 Annexure-1: Design of status label affixing
10.2 Annexure-2: Quarantined Label Template
10.3 Annexure-3: Sampled Label Template
10.4 Annexure-4: Under Test Label Template
10.5 Annexure-5: Passed Label Template
10.6 Annexure-6: Rejected Label Template
Abdus Sobhan Salim is professional experienced pharmacist in pharmaceuticals, author and founder of pharmabossbd.com, the first Bangladeshi pharmaceutical blogger since 2019.
