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,