Standard Operating Procedure for Raw Material Inspection for Lotions
1) Purpose
The purpose of this SOP is to establish procedures for the inspection and acceptance of raw materials used in the production of lotions to ensure they meet quality standards and specifications.
2) Scope
This SOP applies to all personnel involved in the receipt, inspection, and testing of raw materials intended for use in lotions production within the pharmaceutical manufacturing facility.
3) Responsibilities
The responsibilities for executing this SOP are as follows:
Receiving Personnel:
- Receive incoming raw materials and verify accompanying documentation.
- Ensure proper storage and handling of raw materials pending inspection.
Quality Control (QC) Personnel:
- Perform visual inspection and sampling of raw materials according to defined procedures and sampling plans.
- Conduct testing or coordinate testing by qualified personnel to verify material specifications.
Quality Assurance (QA) Personnel:
- Review inspection and testing results to determine acceptance or rejection of raw materials.
- Ensure compliance with SOPs, specifications, and regulatory requirements.
4) Procedure
4.1 Receipt of Raw Materials:
- Receive raw materials in designated receiving areas and verify quantities against accompanying documentation (e.g., packing list).
- Inspect packaging for integrity and check for any visible damage or contamination.
4.2 Documentation Review:
- Review accompanying documentation, including certificates of analysis (CoA), supplier qualification documents, and regulatory compliance certificates.
- Verify that documentation meets specified requirements and is complete and accurate.
4.3 Visual Inspection:
- Perform visual inspection of raw materials for physical appearance, color, odor, and any signs of contamination or deterioration.
- Reject materials with visible defects or discrepancies from specifications.
4.4 Sampling:
- Follow sampling procedures and sampling plans approved for each raw material type.
- Collect representative samples for testing based on batch size and sampling frequency.
4.5 Testing:
- Perform or coordinate testing of raw materials according to approved testing methods and specifications.
- Ensure testing is conducted by qualified personnel using calibrated equipment.
4.6 Acceptance Criteria:
- Evaluate inspection and testing results against established acceptance criteria.
- Accept or reject raw materials based on compliance with specifications and quality standards.
4.7 Rejection and Disposition:
- If raw materials do not meet acceptance criteria, initiate rejection procedures.
- Segregate rejected materials and arrange for disposal or return to supplier as per established procedures.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
- Raw Material Inspection Records
- Certificates of Analysis (CoA)
- Supplier Qualification Documents
7) Reference, if any
- ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- USP <1231>: Water for Pharmaceutical Purposes
8) SOP Version
Version 1.0
