Documentation Procedures for MDI Production
1) Purpose
The purpose of this SOP is to establish procedures for the documentation of activities, processes, and events related to the production of metered-dose inhalers (MDIs) to ensure traceability, data integrity, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in documenting activities within the MDI production facility, including production operators, quality assurance personnel, and documentation control staff.
3) Responsibilities
The responsibilities for this SOP include maintaining accurate and up-to-date documentation, ensuring completeness of records, and adhering to Good Documentation Practices (GDP). Specific roles include:
Production Operators: Document production activities, including batch records and process deviations.
Quality Assurance Personnel: Review and approve documentation to ensure compliance with quality standards.
Documentation Control Staff: Manage document control processes, including version control and distribution.
4) Procedure
4.1 Document Preparation
4.1.1 Prepare document templates for batch records, SOPs, and other relevant documents.
4.1.2 Include necessary sections such as title, purpose, scope, responsibilities, procedures, and references.
4.2 Document Creation and Review
4.2.1 Create documents using approved templates and ensure all required information is documented accurately.
4.2.2 Review documents for completeness, accuracy,
4.3 Document Approval and Distribution
4.3.1 Obtain approval from authorized personnel (e.g., production manager, quality assurance manager).
4.3.2 Distribute approved documents to relevant personnel and departments as per distribution list.
4.4 Document Control and Revision
4.4.1 Maintain a document control system to track document versions, revisions, and obsolescence.
4.4.2 Ensure controlled documents are accessible only to authorized personnel and are updated as necessary.
4.5 Document Retrieval and Archiving
4.5.1 Establish procedures for document retrieval during audits, inspections, or as needed.
4.5.2 Archive documents in accordance with retention schedules and regulatory requirements.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
GDP: Good Documentation Practices
SOP: Standard Operating Procedure
6) Documents, if any
Document templates, document control procedures, distribution lists, and document retention schedules should be maintained.
7) Reference, if any
Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for documentation requirements in pharmaceutical manufacturing.
8) SOP Version
Version 1.0
