1. Purpose
This Standard Operating Procedure (SOP) outlines the procedures for ensuring labelling compliance within [Company Name] to maintain regulatory standards and ensure accurate representation of products.
2. Scope
This SOP applies to all employees involved in the creation, printing, and application of labels on products within [Company Name].
3. Responsibilities
- Quality Assurance Manager: Oversees the implementation of labelling compliance procedures and ensures adherence to regulatory standards.
- Production Team: Responsible for printing and applying labels accurately according to the specifications provided.
- Regulatory Affairs Officer: Ensures that all labels comply with relevant regulations and standards.
- Labelling Specialist: Provides expertise in creating and designing labels that meet regulatory requirements.
4. Procedure
4.1 Label Design and Approval
- 4.1.1 The Labelling Specialist designs labels according to regulatory requirements and product specifications.
- 4.1.2 The designed label is submitted to the Regulatory Affairs Officer for review and approval.
- 4.1.3 Once approved, the label design is sent to the Production Team for printing.
4.2 Label Printing
- 4.2.1 The Production Team ensures that the correct label templates are loaded into the printing system.
- 4.2.2 Labels are printed using a calibrated printer to ensure accurate color and text representation.
- 4.2.3 Prior to printing, a sample label is printed and checked for accuracy by the Quality Assurance Manager.
- 4.2.4 Once the sample is approved, bulk printing of labels can proceed.
4.3 Label Application
- 4.3.1 Labels are applied to products in a designated area by trained personnel.
- 4.3.2 Personnel ensure that labels are applied straight, without wrinkles or air bubbles, and in the correct orientation.
- 4.3.3 Labels are applied securely to prevent peeling or damage during handling and transportation.
4.4 Label Verification
- 4.4.1 The Quality Assurance Manager conducts random checks on labelled products to verify accuracy and compliance.
- 4.4.2 Any discrepancies or non-compliance issues are documented and reported to the Regulatory Affairs Officer for investigation and corrective action.
4.5 Record Keeping
- 4.5.1 Records of label designs, approvals, printing, application, and verification are maintained in a secure database.
- 4.5.2 Records are kept for a specified period as per regulatory requirements and company policies.
5. Training
- 5.1 All employees involved in the labelling process receive training on this SOP and relevant regulatory requirements.
- 5.2 Training records are maintained to ensure compliance with internal and external audit requirements.
6. Documentation
- 6.1 This SOP is documented and made available to all relevant personnel.
- 6.2 Any updates or revisions to this SOP are communicated promptly to all affected employees.
7. Compliance
- 7.1 Compliance with this SOP is mandatory for all employees involved in the labelling process.
- 7.2 Failure to comply may result in disciplinary action as per company policies.
8. Revision History
- 8.1 Version 1.0: [Date] – Initial release.
- 8.2 Version 1.1: [Date] – Updated procedures for clarity and compliance with regulatory changes.
9. References
- List any relevant regulatory standards, guidelines, or internal policies referenced in this SOP.
10. Approval
- This SOP is approved by [Name and Position] on [Date].
- For more articles, Kindly Click here.
- For pharmaceutical jobs, follow us on LinkedIn
- For Editable SOPs in word format contact us on info@pharmaceuticalcarrier.com
- For more information kindly follow us on pharmaguidelines.co.uk
