Documentation Control Procedures in MDI Production
1) Purpose
The purpose of this SOP is to establish procedures for the control, issuance, revision, and archival of documents in metered-dose inhaler (MDI) production to ensure accuracy, traceability, and compliance with regulatory requirements.
2) Scope
This SOP applies to all documents and records generated, used, or maintained within MDI production facilities, including but not limited to batch records, standard operating procedures (SOPs), specifications, and validation documents.
3) Responsibilities
The responsibilities for this SOP include document creation, approval, distribution, retrieval, revision, and archival to maintain document control throughout its lifecycle.
4) Procedure
4.1 Document Creation and Approval
4.1.1 Identify the need for new documents or revisions based on changes in processes, equipment, or regulatory requirements.
4.1.2 Draft documents using approved templates and formats, ensuring clarity, accuracy, and compliance with relevant standards.
4.1.3 Obtain approval from designated personnel, including quality assurance, production, and regulatory affairs, as applicable.
4.2 Document Distribution
4.2.1 Distribute approved documents to authorized personnel or departments electronically or in hard copy as per distribution lists.
4.2.2 Ensure controlled copies are clearly labeled with document status (e.g., draft, approved) and revision number/date.
4.3 Document Retrieval and Use
4.3.1 Maintain a master document index or database to facilitate document retrieval and access control.
4.3.2 Ensure personnel use only the most current and approved versions of documents during operations.
4.4 Document Revision
4.4.1 Establish procedures for document revision, including revision tracking, review, and approval processes.
4.4.2 Implement change control procedures to assess the impact of document revisions and obtain necessary approvals before implementation.
4.5 Document Archival and Retention
4.5.1 Define document retention periods based on regulatory requirements, business needs, and archival policies.
4.5.2 Archive obsolete or superseded documents in a secure location with controlled access and ensure traceability for retrieval purposes.
4.6 Document Control Logs and Records
4.6.1 Maintain document control logs or electronic records to track document status, distribution history, revisions, and approvals.
4.6.2 Document any deviations from SOPs related to document control and implement corrective actions as necessary.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
6) Documents, if any
Document templates, distribution lists, change control forms, document retention schedules, and document control logs should be maintained as part of the quality management system.
7) Reference, if any
Refer to document control guidelines from regulatory agencies, pharmacopeial standards (e.g., ICH Q7), and internal quality management procedures.
8) SOP Version
Version 1.0
