Standard Operating Procedure for Labeling and Coding on FFS Machine
1) Purpose
The purpose of this SOP is to outline the procedures for labeling and coding pharmaceutical products on the Form-Fill-Seal (FFS) machine to ensure accurate product identification and compliance with regulatory requirements.
2) Scope
This SOP applies to the labeling and coding activities conducted on FFS machines during pharmaceutical manufacturing processes.
3) Responsibilities
3.1 Production Operators
- Ensure correct setup and operation of labeling and coding systems.
- Monitor label and code application for accuracy and legibility.
3.2 Quality Control (QC) Personnel
- Verify labeling and coding accuracy and compliance with specifications.
- Perform inspections and checks to prevent labeling errors.
4) Procedure
4.1 Setup and Calibration
- Calibrate labeling and coding equipment according to manufacturer’s instructions.
- Verify correct placement and alignment of labels and codes.
4.2 Labeling Process
- Load labeling materials onto the FFS machine in designated feeders.
- Initiate label application process and monitor for proper adherence.
4.3 Coding Process
- Input product-specific codes into the coding system.
- Activate coding mechanism and ensure accurate printing or embossing.
4.4 Inspection and Verification
- Inspect labeled and coded products for accuracy and clarity.
- Reject any products with labeling or coding defects and document findings.
5) Abbreviations, if any
FFS: Form-Fill-Seal
QC: Quality Control
6) Documents, if any
- Labeling and Coding Setup Checklist
- Inspection and Verification Logs
7) Reference, if any
ISO 15378: Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
FDA Guidance for Industry: Labeling OTC Human Drug Products
8) SOP Version
Version 1.0