Standard Operating Procedure for Raw Material Inspection for Gels
1) Purpose
The purpose of this SOP is to establish procedures for the inspection and acceptance of raw materials used in the production of gels to ensure quality, safety, and compliance with specifications.
2) Scope
This SOP applies to all personnel involved in the receiving, inspection, and approval of raw materials for gel production within the pharmaceutical manufacturing facility.
3) Responsibilities
Quality Control (QC) Inspector: Perform raw material inspections as per this SOP.
Purchasing Officer: Coordinate with suppliers for timely delivery and documentation of raw materials.
Production Supervisor: Ensure availability of approved raw materials for production activities.
4) Procedure
4.1 Receipt of Raw Materials
4.1.1 Receive raw materials in designated receiving areas.
4.1.2 Verify shipment documents (e.g., packing list, certificate of analysis) against purchase orders.
4.2 Initial Visual Inspection
4.2.1 Inspect containers or packaging for integrity, cleanliness, and labeling.
4.2.2 Check for any visible damage, contamination, or discrepancies with supplier specifications.
4.3 Sampling and Testing
4.3.1 Take representative samples from each lot according to sampling plans and procedures.
4.3.2 Perform required tests (e.g., identity, purity, potency) based on approved test methods and specifications.
4.4 Quality Assessment
4.4.1 Evaluate test results against acceptance criteria specified in the material specifications.
4.4.2 Record inspection and test results accurately in batch records or electronic systems.
4.5 Release or Rejection Decision
4.5.1 Make release or rejection decisions based on inspection findings and test results.
4.5.2 Obtain necessary approvals from QC Supervisor or authorized personnel for material disposition.
4.6 Storage and Handling
4.6.1 Store approved materials in designated areas with appropriate labeling and segregation.
4.6.2 Ensure proper handling to prevent contamination, degradation, or mix-up during storage.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
6) Documents, if any
– Certificate of Analysis (CoA) from Suppliers
– Raw Material Inspection Reports
– SOP for Raw Material Sampling and Testing
7) Reference, if any
– USP <1078> Good Manufacturing Practices for Bulk Pharmaceutical Excipients
– ICH Q9: Quality Risk Management
– Supplier Quality Agreements and Contracts
8) SOP Version
Version 1.0
