Supplier Qualification Procedures for Raw Materials in MDI Production
1) Purpose
The purpose of this SOP is to establish procedures for qualifying suppliers of raw materials used in metered-dose inhaler (MDI) production to ensure quality, consistency, and compliance with regulatory requirements.
2) Scope
This SOP applies to all raw materials suppliers providing components such as active pharmaceutical ingredients (APIs), excipients, propellants, stabilizers, and packaging materials for MDI production.
3) Responsibilities
The responsibilities for this SOP include assessing supplier capabilities, conducting audits or assessments, and maintaining supplier qualification records.
4) Procedure
4.1 Supplier Evaluation and Selection
4.1.1 Identify potential suppliers based on product requirements, quality standards, and regulatory compliance.
4.1.2 Evaluate supplier capabilities, including manufacturing practices, quality management systems, and compliance with relevant standards.
4.2 Supplier Qualification Audit
4.2.1 Conduct on-site audits or assessments of potential suppliers to verify compliance with specifications and quality requirements.
4.2.2 Assess supplier facilities, processes, documentation, and adherence to Good Manufacturing Practices (GMP).
4.3 Qualification Criteria
4.3.1 Establish qualification criteria for suppliers, including quality standards, regulatory compliance, reliability, and continuity of supply.
4.3.2 Define acceptance criteria based on risk assessment and criticality of raw materials to MDI production.
4.4 Qualification Approval
4.4.1 Review audit findings and supplier qualification documentation for approval or rejection.
4.4.2 Obtain necessary approvals from quality assurance or procurement departments before initiating supply agreements.
4.5 Ongoing Supplier Performance Monitoring
4.5.1 Monitor supplier performance through periodic reviews, quality metrics, and feedback from internal stakeholders.
4.5.2 Address any non-conformances or deviations promptly through corrective actions and continuous improvement initiatives.
4.6 Documentation and Records
4.6.1 Maintain comprehensive records of supplier evaluations, audits, qualification decisions, and ongoing performance assessments.
4.6.2 Document supplier agreements, specifications, quality agreements, and any changes or updates to supplier status.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
GMP: Good Manufacturing Practices
6) Documents, if any
Supplier audit reports, qualification records, performance metrics, quality agreements, and correspondence with suppliers should be maintained as part of the supplier management system.
7) Reference, if any
Refer to supplier qualification guidelines from regulatory agencies, industry standards (e.g., ICH Q7), and internal quality management procedures.
8) SOP Version
Version 1.0
