Standard Operating Procedure for Document Control System in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish procedures for the control and management of documents in the manufacturing of ocular dosage forms to ensure accuracy, consistency, and compliance with regulatory requirements.

2) Scope

This SOP applies to all documents related to the manufacturing, quality control, and quality assurance of ocular dosage forms, including but not limited to batch records, SOPs, quality manuals, and validation protocols.

3) Responsibilities

Document control managers and quality assurance personnel are responsible for implementing and maintaining compliance with this SOP. All employees are responsible for adhering to the document control procedures and practices.

4) Procedure

4.1 Document Creation and Approval

1. Develop and create documents using approved templates and formats.
2. Ensure documents are reviewed and approved by authorized personnel before implementation.
3. Assign unique identification numbers to each document for tracking and control purposes.

4.2 Document Distribution and Accessibility

1. Distribute approved documents to relevant departments and personnel as required.
2. Ensure that documents are easily accessible to authorized personnel while maintaining security and confidentiality.
3. Implement version control to manage updates and revisions to documents.

4.3 Document Revision and Control

1. Review and update documents regularly to ensure they remain current and relevant.
2. Document all changes and revisions, including the reason for the change and the approval date.
3. Replace outdated documents with revised versions and ensure proper disposal of obsolete documents.

4.4 Document Archiving and Retention

1. Archive documents in a secure and organized manner according to regulatory and company retention policies.
2. Maintain records of archived documents, including the location and retention period.
3. Ensure documents are retained for the required duration and are accessible for audits and inspections.

4.5 Document Retrieval and Disposal

1. Implement procedures for the retrieval of archived documents as needed for reference or regulatory inspections.
2. Dispose of documents securely and in compliance with regulatory and environmental requirements at the end of their retention period.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

1. Document control records
2. Document revision logs
3. Document disposal certificates

7) Reference, if any

Good Manufacturing Practice (GMP) guidelines for pharmaceutical manufacturing

8) SOP Version

Version 1.0