Pharmaceutical Labeling SOP is a GMP activity that ensures every product is correctly identified before process and distribution. A well-defined Labeling SOP establishes standardized procedures for label issuance, verification and control prevent mix-ups, ensure regulatory compliance, and maintain product quality and patient safety.
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Purpose of Pharmaceutical Labeling SOP
To describe a procedure for Labeling Policy. Proper label control ensures that the correct label is applied to the correct product. It differentiate the product stage wise and display the actual status of the product.
Scope of Pharmaceutical Labeling SOP
This SOP is applicable for the Labeling Policy used at XYZ company. It is applicable for each and every department in the company.
Responsibilities including Pharmaceutical Labeling SOP:
| Designation | Responsibilities |
| Officer/ executive of Respective department | Responsible for preparation of label.Responsible for periodic review of SOP.Responsible to follow the procedure mentioned in this SOP. |
| Department Head / designee | Responsible to approve/finalize the label.Department Head shall be responsible for ensuring the technical content of documents with respect to process, materials to be used, conditions to be maintained etc. within the department and other department(s). |
| QA Officer/ Executive | Responsible for implementation of SOP and maintain the records according to the SOP. |
Reference:
EUdra Lex Volume 4
21 CFR Part 211
PIC/S PE 009
Abbreviations:
SOP : Standard Operating Procedure
QA : Quality Assurance
RM : Raw Material
NA : Not Applicable
No. : Number
ID : Identification
IPQA : In Process Quality Assurance
Training Requirements
Personnel must:
- Read the SOP.
- Complete training before performing related activities.
- Undergo periodic retraining as required.
Procedure for Pharmaceutical Labeling SOP
Concern department will prepare the specimen for label.
Head of concern department will approve the label.
Approved format will send to QA department for their approval. After QA approval format will send to purchase department for printing of the label.
QA department will update the standard operating procedure of Labeling Policy accordingly.
Purchase department will receive the blue print of label and get the approval of the QA department for final printing of labels.
If in case there is shortage of labels or delay from vendor for the readymade labels then required quantity of labels shall be printed on coloured papers by concerned departments and get it verified from QA head.
The details of the labels are given below.
QUARANTINE: After receiving the consignment of raw/packing material from manufacturer / supplier, warehouse person shall affix the ‘QUARANTINE’ labels on container before sampling of material.
APPROVED: After Approval of Samples QC shall affix ‘APPROVED’ label on the raw material & packing material container.
SAMPLED: Quality control person shall affix the ‘SAMPLED’ label on the container after sampling on each container.
UNDER TEST: After receiving the material from manufacturer/ supplier, Quality Control person shall affix the ‘UNDER TEST’ labels on container after sampling of materials.
REJECTED: This label shall be affixed on RM/PM or any material, batch which does not complies as per spec.
UNDER CLEANING: This label shall be affixed by concerned department prior to cleaning.
CLEANED: This label shall be affixed by Concerned Department person after cleaning of the equipment/instrument, containers & accessories.
EQUIPMENT QUALIFICATION STATUS LABEL: This label shall be affixed by QA for identification of qualification and validation status.
EQUIPMENT CALIBRATION: This label shall be affixed by concerned department on the calibrated instrument/equipment.
UNDER BREAKDOWN: When an Instrument/equipment/Area is not working properly then the concerned department will affix the label ‘UNDER BREAKDOWN’ on the equipment/ instrument/area.
PREVENTIVE MAINTENANCE: The engineering person shall affix the “PREVENTIVE MAINTENANCE” labels on equipment as per their preventive maintenance schedule.
HOLD: This label shall be affixed on products/materials which do not comply as per specification.
SAMPLE FOR ANALYSIS. This label shall be affixed by QA person on all types of sample which is send to QC for analysis purpose.
Change History
| Effective Date | Nature of revision | Change Control No. | Reason for review |