Standard Operating Procedure for Inspection and Testing of Incoming Raw Materials
1) Purpose
The purpose of this SOP is to establish procedures for the inspection and testing of incoming raw materials used in the manufacturing of dental dosage forms to ensure they meet quality standards and specifications.
2) Scope
This SOP applies to all incoming raw materials received for use in the production of dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Quality Assurance (QA) Department is responsible for executing inspection and testing procedures. The Purchasing Department is responsible for coordinating with suppliers and ensuring compliance with this SOP.
4) Procedure
4.1 Receipt and Identification
4.1.1 Receive incoming raw materials in designated receiving areas and inspect accompanying documentation (e.g., packing list, certificates of analysis).
4.1.2 Verify material identification and quantity against purchase orders and specifications.
4.2 Visual Inspection
4.2.1 Conduct visual inspection of raw materials for any signs of damage, contamination, or discrepancies.
4.2.2 Reject any materials that do not meet visual inspection criteria or show signs of damage or tampering.
4.3 Sampling and Testing
4.3.1 Collect representative samples of raw materials for testing according to sampling plans and procedures.
4.3.2 Perform testing of samples using approved analytical methods and equipment to verify quality parameters (e.g., identity, purity, potency).
4.3.3 Compare test results against established acceptance criteria and specifications.
4.4 Approval or Rejection
4.4.1 Record inspection and test results in designated quality control documents (e.g., batch records, testing logs).
4.4.2 Release approved materials for use in production or reject materials that do not meet specifications.
4.5 Storage and Handling
4.5.1 Store approved materials in designated storage areas under appropriate conditions (e.g., temperature, humidity).
4.5.2 Label materials with necessary identification and handling instructions.
4.6 Documentation
4.6.1 Maintain accurate records of all inspection, testing, and acceptance/rejection activities.
4.6.2 Archive documentation according to retention policies and regulatory requirements.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QA – Quality Assurance
6) Documents, if any
Material Inspection and Testing Records
Supplier Certificates of Analysis
Batch Records
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
Pharmacopeial standards (e.g., USP, EP)
8) SOP Version
Version 1.0
