Standard Operating Procedure for Raw Material Inspection for Transdermal Patches
1) Purpose
The purpose of this SOP is to establish procedures for the inspection and testing of raw materials used in the manufacturing of transdermal patches to ensure they meet quality specifications and regulatory requirements.
2) Scope
This SOP applies to all raw materials received and used in the production of transdermal patches within the facility.
3) Responsibilities
The Quality Control (QC) Department is responsible for implementing and overseeing raw material inspection activities outlined in this SOP. Purchasing and Production Departments collaborate in the process as needed.
4) Procedure
4.1 Receipt and Sampling
- 4.1.1 Receive raw materials in designated receiving areas and verify against accompanying documentation (e.g., purchase orders, certificates of analysis).
- 4.1.2 Sample raw materials according to sampling plans based on regulatory requirements and supplier agreements.
4.2 Visual Inspection
- 4.2.1 Perform visual inspection of raw materials for damage, contamination, or discrepancies in labeling or packaging.
- 4.2.2 Document any observed deviations or issues and communicate with the supplier or Quality Assurance (QA) for resolution.
4.3 Testing and Analysis
- 4.3.1 Conduct identity testing using appropriate analytical methods (e.g., spectroscopy, chromatography) to verify the composition and purity of raw materials.
- 4.3.2 Perform physical and chemical tests to determine characteristics such as particle size, viscosity, moisture content, and pH.
4.4 Acceptance Criteria
- 4.4.1 Compare test results against established acceptance criteria based on pharmacopeial standards, internal specifications, or regulatory guidelines.
- 4.4.2 Reject raw materials that do not meet acceptance criteria and initiate supplier notification and corrective action processes.
4.5 Documentation
- 4.5.1 Record all inspection and testing activities in batch records, laboratory notebooks, or electronic systems.
- 4.5.2 Maintain documentation of raw material inspection results, including test reports, certificates of analysis, and any deviations or corrective actions taken.
4.6 Quarantine and Release
- 4.6.1 Place approved raw materials in designated quarantine areas pending final release by Quality Assurance (QA).
- 4.6.2 Ensure proper labeling and segregation of quarantined materials to prevent unintended use.
- 4.6.3 Release raw materials for production use only after QA approval and verification of all required documentation.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Batch Records
Certificates of Analysis
7) Reference, if any
USP General Chapter 1078: Good Manufacturing Practices for Bulk Pharmaceutical Excipients
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0