Standard Operating Procedure for Raw Material Testing and Approval
1) Purpose
The purpose of this SOP is to establish procedures for the testing and approval of raw materials to ensure they meet specified quality standards before use in the manufacturing process.
2) Scope
This SOP applies to all personnel involved in the testing and approval of raw materials for the production of intramuscular, subcutaneous, and intravenous injection products.
3) Responsibilities
The responsibilities of this SOP include:
– Quality Control (QC) Department: Conducting tests and ensuring raw materials meet quality standards.
– Quality Assurance (QA) Department: Reviewing and approving test results and ensuring compliance with SOP.
– Warehouse Personnel: Holding materials in quarantine until approval.
4) Procedure
4.1 Sampling of Raw Materials
4.1.1 Collect samples from each batch of raw materials according to the sampling plan.
4.1.2 Label samples with unique identification numbers and log them in the sample record.
4.2 Testing of Raw Materials
4.2.1 Perform tests according to the specified methods and standards for each type of raw material.
4.2.2 Record test results in the raw material testing log and ensure they are reviewed by QC.
4.3 Approval of Raw Materials
4.3.1 Submit test results to QA for review and approval.
4.3.2 If materials meet all quality specifications, QA will approve them for use and update the status in the inventory system.
4.3.3 If materials do not meet specifications, they will be rejected and segregated from approved materials.
4.4 Documentation
4.4.1 Maintain records of all tests, results, and approvals.
4.4.2 Ensure all documentation is signed and dated by the responsible personnel.
4.5 Handling of Approved and Rejected Materials
4.5.1 Move approved materials to the designated storage area for use in manufacturing.
4.5.2 Store rejected materials in a separate area and follow procedures for their disposal or return.
5) Abbreviations, if any
– QA: Quality Assurance
– QC: Quality Control
6) Documents, if any
– Sampling Records
– Raw Material Testing Log
– Approval Records
7) Reference, if any
– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards
8) SOP Version
Version 1.0
