Standard Operating Procedure for Regulatory Compliance System in Ocular Dosage Form Manufacturing
1) Purpose
The purpose of this SOP is to establish a Regulatory Compliance System (RCS) to ensure that all activities related to the manufacturing, testing, and distribution of ocular dosage forms comply with applicable regulatory requirements. This SOP aims to maintain adherence to regulatory guidelines, standards, and legal obligations.
2) Scope
This SOP applies to all personnel involved in regulatory affairs, quality assurance, production, and distribution of ocular dosage forms, including eye drops, ointments, gels, and inserts. It encompasses regulatory submissions, registrations, licenses, approvals, and ongoing compliance activities.
3) Responsibilities
The Regulatory Affairs department is responsible for implementing and maintaining the RCS. QA personnel ensure that all processes and documentation comply with current regulatory requirements and facilitate interactions with regulatory authorities. All personnel are accountable for following established procedures and contributing to compliance objectives.
4) Procedure
4.1 Regulatory Submissions
- Prepare and submit applications for regulatory approvals, registrations, and licenses required for the manufacturing and distribution of ocular dosage forms.
- Ensure submissions are complete, accurate, and submitted within specified timelines.
- Maintain records of regulatory submissions, correspondence with regulatory authorities, and approval statuses.
4.2 Regulatory Compliance Monitoring
- Monitor regulatory changes, updates, and guidelines relevant to ocular dosage forms and
4.3 Regulatory Audits and Inspections
- Prepare for and participate in regulatory audits and inspections conducted by health authorities or external auditors.
- Coordinate responses to audit findings and observations, including corrective and preventive actions (CAPAs).
- Ensure timely closure of audit findings and follow-up activities.
4.4 Regulatory Documentation Control
- Establish a Documentation Control System to manage regulatory filings, submissions, approvals, and compliance documentation.
- Maintain document version control, archival, and retrieval systems for regulatory documents.
- Ensure all regulatory documents are current, approved, and accessible to authorized personnel.
4.5 Compliance Reporting
- Prepare and submit periodic compliance reports to regulatory authorities as required by regulations and license agreements.
- Document compliance metrics, deviations, and corrective actions taken to address non-compliance issues.
- Ensure accuracy and completeness of compliance reports and records.
5) Abbreviations, if any
SOP: Standard Operating Procedure
RCS: Regulatory Compliance System
QA: Quality Assurance
CAPA: Corrective and Preventive Action
6) Documents, if any
- Regulatory Submissions and Approvals
- Regulatory Audit Reports
- Regulatory Compliance Reports
- Correspondence with Regulatory Authorities
- Documentation Control Records
7) Reference, if any
Good Manufacturing Practices (GMP) guidelines
International Conference on Harmonization (ICH) guidelines
Local regulatory requirements and guidelines
8) SOP Version
Version 1.0