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

1) Purpose

The purpose of this SOP is to establish a comprehensive compliance control system to ensure that all activities in the manufacturing of ocular dosage forms adhere to applicable regulatory requirements, industry standards, and internal policies.

2) Scope

This SOP applies to all departments and personnel involved in the manufacturing of ocular dosage forms, including production, quality control, quality assurance, regulatory affairs, and any other relevant functions.

3) Responsibilities

The quality assurance (QA) department is responsible for overseeing the compliance control system. All employees involved in manufacturing and quality control are responsible for adhering to the procedures and practices outlined in this SOP.

4) Procedure

4.1 Regulatory Awareness and Updates

1. Maintain up-to-date knowledge of applicable regulatory requirements, including local, national, and international guidelines relevant to ocular dosage forms.
2. Subscribe to regulatory updates and industry publications to stay informed of changes and new requirements.
3. Disseminate regulatory updates to relevant departments and ensure that necessary adjustments are made to procedures and practices.

4.2 Documentation and Record Keeping

1. Ensure that all documentation, including SOPs, batch records, validation protocols, and quality control reports, are maintained accurately and up-to-date.
2. Implement a document control system to manage the creation, review, approval, and distribution of controlled documents.
3. Maintain records of all manufacturing and quality control activities, ensuring that they are complete, accurate, and retrievable.

4.3 Training and Competency

1. Develop and implement a training program to ensure that all personnel are knowledgeable about regulatory requirements and internal policies.
2. Conduct regular training sessions and assessments to maintain and update employees’ knowledge and skills.
3. Maintain training records and ensure that all personnel have completed required training before performing tasks.

4.4 Internal Audits and Inspections

1. Conduct regular internal audits to assess compliance with regulatory requirements and internal policies.
2. Develop an audit schedule and checklist based on critical compliance areas.
3. Document audit findings, and take corrective and preventive actions (CAPA) to address any identified non-compliances.
4. Conduct follow-up audits to ensure the effectiveness of CAPA and continuous compliance improvement.

4.5 Regulatory Inspections

1. Prepare for regulatory inspections by maintaining compliance with all applicable requirements and ensuring that documentation is readily available.
2. Coordinate with regulatory authorities during inspections, providing requested information and documentation promptly.
3. Address any findings from regulatory inspections with appropriate CAPA and document the actions taken.

4.6 Continuous Improvement

1. Implement a continuous improvement program to regularly review and enhance compliance processes and practices.
2. Encourage feedback from employees to identify areas for improvement and make necessary adjustments.
3. Monitor industry trends and best practices to adopt new methods and technologies that enhance compliance.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
CAPA: Corrective and Preventive Actions

6) Documents, if any

1. Regulatory guidelines and updates
2. Controlled documents (SOPs, batch records, validation protocols)
3. Training records
4. Internal audit reports
5. Regulatory inspection reports

7) Reference, if any

Good Manufacturing Practice (GMP) guidelines for pharmaceutical manufacturing

8) SOP Version

Version 1.0