Raw Material Inspection Procedures for MDIs
1) Purpose
The purpose of this SOP is to establish procedures for the inspection and acceptance of raw materials used in the manufacturing of metered-dose inhalers (MDIs) to ensure quality, safety, and compliance with specifications.
2) Scope
This SOP applies to all personnel involved in the inspection and sampling of raw materials at the MDI production facility, including quality control personnel, procurement officers, and production supervisors.
3) Responsibilities
The responsibilities for this SOP include conducting inspections, sampling raw materials, performing tests as required, and documenting inspection results. Specific roles include:
Quality Control Personnel: Perform inspections and tests according to approved procedures.
Procurement Officers: Ensure raw materials meet specifications before acceptance.
Production Supervisors: Monitor raw material storage and handling to prevent mix-ups or contamination.
4) Procedure
4.1 Receipt and Sampling
4.1.1 Receive raw materials in designated receiving areas and verify accompanying documentation.
4.1.2 Sample raw materials according to sampling plans or sampling procedures.
4.2 Visual Inspection
4.2.1 Inspect raw materials for visible defects, damage, or discrepancies with accompanying documentation.
4.2.2 Record inspection findings and document any deviations observed.
4.3 Physical and Chemical Testing
4.3.1 Perform physical tests (e.g., appearance, weight) and chemical tests (e.g., identity, purity) as per specifications.
4.3.2 Use validated test methods and equipment for testing raw materials.
4.4 Acceptance Criteria
4.4.1 Compare test results against established acceptance criteria and specifications.
4.4.2 Determine acceptance or rejection of raw materials based on test results and quality standards.
4.5 Documentation and Release
4.5.1 Document inspection and test results in raw material inspection records or batch records.
4.5.2 Release accepted raw materials for use in production upon completion of inspection and testing.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
6) Documents, if any
Raw material specifications, sampling plans, test methods, inspection records, and release certificates should be maintained.
7) Reference, if any
Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for raw material testing and acceptance criteria in pharmaceutical manufacturing.
8) SOP Version
Version 1.0
