Standard Operating Procedure for Artwork and Label Approval

1) Purpose

This SOP outlines the procedures for the approval of artwork and labeling used in the manufacture and packaging of pharmaceutical products to ensure compliance with regulatory requirements and product specifications.

2) Scope

This SOP applies to all artwork and labeling used for pharmaceutical products, including primary and secondary packaging, product labels, patient information leaflets, and outer cartons.

3) Responsibilities

The Regulatory Affairs Manager or designated personnel are responsible for overseeing the artwork and labeling approval process. Quality assurance, production, marketing, and other relevant departments are responsible for providing input and ensuring compliance with this SOP.

4) Procedure

4.1 Artwork Creation and Submission

1. Create artwork based on approved templates, regulatory requirements, and branding guidelines.
2. Submit artwork files along with relevant documentation (e.g., text translations, regulatory submissions) for approval.

4.2 Review and Approval Process

1. Initiate the review process by assembling a cross-functional team including regulatory affairs, quality control, marketing, and legal representatives.
2. Review artwork for accuracy, completeness, compliance with regulatory requirements, and adherence to company standards.
3. Approve artwork after verification and ensure all necessary changes are documented and incorporated.

4.3 Labeling Content Verification

1. Verify labeling content accuracy, including product name, strength, dosage form, batch number, expiration date, and other required information.
2. Ensure compliance with applicable regulations (e.g., FDA labeling requirements, EU directives).

4.4 Proofreading and Localization

1. Conduct proofreading and localization checks for multilingual labeling, ensuring accuracy and consistency across all languages.
2. Verify translations against approved source documents and regulatory submissions.

4.5 Approval Documentation

1. Maintain accurate records of artwork approval, including approval dates, signatures of responsible personnel, and version control.
2. Archive approved artwork and labeling documents for future reference and regulatory inspections.

4.6 Change Control

1. Implement a change control process to manage revisions or updates to approved artwork and labeling.
2. Ensure changes are documented, assessed for impact on quality and compliance, and approved prior to implementation.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Artwork Approval Forms, Labeling Compliance Reports, Change Control Records, Translation Verification Records

7) Reference, if any

Regulatory guidelines and requirements for labeling and artwork approval, such as FDA regulations on prescription drug labeling and EU directives on packaging and labeling requirements.

8) SOP Version

Version 1.0