Standard Operating Procedure for Regulatory Document Control
Purpose:
The purpose of this SOP is to establish a systematic approach for the control, management, and maintenance of regulatory documents within the organization, ensuring accuracy, version control, and accessibility for regulatory compliance.
Scope:
This SOP applies to all regulatory documents generated, received, or utilized by the organization, including but not limited to regulatory submissions, regulatory correspondence, standard operating procedures, protocols, and regulatory guidelines.
Responsibilities:
3.1 Regulatory Affairs Department:
Oversee the implementation and maintenance of the document control process.
Designate personnel responsible for document control activities.
Provide training and guidance to employees on document control procedures.
Ensure compliance with regulatory requirements related to document control.
3.2 Document Control Personnel:
Establish and maintain a central repository for regulatory documents.
Assign unique identification numbers or codes to all regulatory documents.
Ensure controlled copies of documents are available and accessible to authorized personnel.
Monitor document revisions, updates, and obsolescence.
Maintain an accurate and up-to-date document register or database.
Facilitate document review, approval, and distribution processes.
Securely store and protect documents from unauthorized access, loss, or damage.
Implement document retention and archiving procedures as per regulatory requirements.
Conduct periodic audits to verify compliance with document control procedures.
3.3 Employees:
Follow document control procedures when creating, reviewing, and using regulatory documents.
Report any document control issues or discrepancies to the Document Control Personnel.
Procedure:
4.1 Document Creation and Review:
4.1.1 Determine the need for a new document or a revision of an existing document.
4.1.2 Assign a unique identification number or code to the document.
4.1.3 Create or revise the document using approved templates and formats.
4.1.4 Include necessary content, such as document title, purpose, scope, and version control information.
4.1.5 Submit the document for review and approval following the organization’s review process.
4.2 Document Approval and Distribution:
4.2.1 Obtain necessary approvals from designated personnel.
4.2.2 Ensure proper version control and identification of approved documents.
4.2.3 Distribute controlled copies of the document to authorized personnel.
4.2.4 Update the document register or database to reflect the latest version and distribution information.
4.3 Document Storage and Access:
4.3.1 Store controlled documents in a secure and organized manner.
4.3.2 Implement access controls to ensure only authorized personnel can access and use the documents.
4.3.3 Maintain backups of electronic documents to prevent loss or damage.
4.4 Document Revision and Obsolescence:
4.4.1 Track document revisions and maintain a clear record of changes made.
4.4.2 Implement a version control system to prevent the use of outdated documents.
4.4.3 Communicate document revisions to relevant personnel.
4.4.4 Identify and remove obsolete documents from circulation.
4.5 Document Retention and Archiving:
4.5.1 Establish a document retention period based on regulatory requirements and organizational policies.
4.5.2 Archive documents according to the approved retention schedule.
4.5.3 Maintain a documented procedure for document retrieval from the archives.
Abbreviations Used (if any):
SOP: Standard Operating Procedure
Documents:
Document Control Policy
Document Register or Database
Document Templates
Reference (if any):
Regulatory guidelines related to document control (e.g., ICH Q10, FDA 21 CFR Part 11)
Organizational quality management system documentation.
SOP Version: [Specify SOP version number and date of the latest revision]
Note: This SOP should be periodically reviewed and updated as necessary to align with changes in regulations, industry best practices, or organizational requirements. Any deviations from this SOP should be documented, reviewed, and approved by the appropriate personnel.
