Standard Operating Procedure for Documentation Control in Aerosol Production
1) Purpose
The purpose of this SOP is to establish a standardized procedure for controlling documentation in aerosol production. This ensures that all documents are accurately maintained, easily retrievable, and protected against unauthorized changes, ensuring compliance with regulatory requirements and quality standards.
2) Scope
This SOP applies to all types of documentation used in aerosol production at [Company Name], including but not limited to SOPs, batch records, logbooks, validation protocols, and quality control records.
3) Responsibilities
Quality Assurance (QA) Manager: Oversee the documentation control process and ensure compliance.
Document Control Coordinator: Manage the distribution, storage, and retrieval of documents.
Department Managers: Ensure that their teams comply with documentation control procedures.
All Personnel: Follow documentation control procedures and ensure proper handling of documents.
4) Procedure
4.1 Document Creation and Approval:
4.1.1 Develop new documents or revise existing documents as necessary.
4.1.2 Ensure all documents are reviewed and approved by relevant stakeholders, including the QA Manager.
4.1.3 Assign a unique document number, version number, and effective date to each document.
4.2 Document Distribution:
4.2.1 Distribute approved documents to relevant departments and personnel.
4.2.2 Maintain a master list of all controlled documents, including their version numbers and distribution locations.
4.2.3 Ensure that obsolete documents are removed from use and replaced with the updated versions.
4.3 Document Storage and Retrieval:
4.3.1 Store all controlled documents in a secure, accessible location, such as a document control room or electronic document management system.
4.3.2 Implement a tracking system for document retrieval, ensuring that documents can be easily located when needed.
4.3.3 Regularly back up electronic documents to prevent data loss.
4.4 Document Review and Revision:
4.4.1 Periodically review documents to ensure they remain current and accurate.
4.4.2 Initiate revisions as necessary, following the same approval process as for new documents.
4.4.3 Update the master list and notify relevant personnel of any changes to documents.
4.5 Document Archiving:
4.5.1 Archive obsolete documents in a designated storage area, ensuring they are clearly marked as archived.
4.5.2 Retain archived documents for a specified period, in accordance with regulatory and company requirements.
4.5.3 Dispose of archived documents securely once the retention period has expired.
4.6 Document Security:
4.6.1 Implement access controls to ensure that only authorized personnel can view or modify controlled documents.
4.6.2 Regularly audit the documentation control system to ensure compliance with security protocols.
4.6.3 Report any security breaches or document discrepancies to the QA Manager immediately.
5) Abbreviations, if any
QA: Quality Assurance
SOP: Standard Operating Procedure
6) Documents, if any
Master List of Controlled Documents
Document Control Forms
Document Revision History Logs
Audit Reports
7) Reference, if any
GMP Guidelines
ISO 9001: Quality Management Systems
FDA Guidance for Industry: Documentation Practices
8) SOP Version
Version 1.0
