Standard Operating Procedure for Raw Material Inspection for Aerosols

1) Purpose

The purpose of this SOP is to establish procedures for the inspection and acceptance of raw materials used in the production of aerosols in the pharmaceutical industry. This ensures that only quality raw materials meeting specified requirements are used in manufacturing processes.

2) Scope

This SOP applies to all raw materials procured and used in aerosol production at [Company Name], including active pharmaceutical ingredients (APIs), propellants, stabilizers, solvents, and packaging components.

3) Responsibilities

Quality Control (QC) Personnel: Responsible for conducting raw material inspections and approvals.
Purchasing Department: Procures raw materials from approved suppliers and provides necessary documentation.
Production Supervisors: Coordinate with QC for sampling and testing of raw materials.

4) Procedure

4.1 Receipt and Sampling:
4.1.1 Receive raw materials in designated receiving area and verify against accompanying documents (e.g., purchase orders, certificates of analysis).
4.1.2 Collect representative samples as per sampling plan and procedures.

4.2 Visual Inspection:
4.2.1 Inspect raw materials visually for any physical defects, contamination, or discrepancies with specifications.
4.2.2 Document observations and take appropriate action if any discrepancies are found.

4.3 Testing and Analysis:
4.3.1 Perform testing and analysis of raw materials according to approved test methods and specifications.
4.3.2 Include tests for identity, purity, potency, and other critical quality attributes as applicable.

4.4 Acceptance Criteria:
4.4.1 Compare test results against established acceptance criteria and specifications.
4.4.2 Reject or quarantine raw materials that do not meet acceptance criteria and initiate supplier notification and investigation.

4.5 Release or Rejection:
4.5.1 Release approved raw materials for use in production after completion of inspection and testing.
4.5.2 Document final disposition of raw materials and update inventory records accordingly.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control

6) Documents, if any

Raw Material Inspection Records
Certificates of Analysis
Supplier Qualification Documents

7) Reference, if any

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Pharmacopeial standards (e.g., USP, EP)

8) SOP Version

Version 1.0