Standard Operating Procedure for Raw Material Inspection for Creams
1) Purpose
The purpose of this SOP is to define the procedures for the inspection and acceptance of raw materials used in creams production to ensure they meet quality specifications and comply with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the receipt, inspection, sampling, and testing of raw materials used in creams production within the pharmaceutical manufacturing facility. It covers procedures from receipt of materials to their release for use in production.
3) Responsibilities
It is the responsibility of the quality control (QC) department, procurement personnel, and production supervisors to follow this SOP. QC personnel conduct inspections and testing, procurement ensures proper documentation and handling of materials, and production supervisors verify material acceptance for use.
4) Procedure
4.1 Receipt of Raw Materials
4.1.1 Receive raw materials in designated receiving areas with controlled environmental conditions.
4.1.2 Verify received quantities against purchase orders and shipping documents.
4.1.3 Notify procurement of any discrepancies in quantity or condition of received materials.
4.2 Initial Inspection
4.2.1 Perform initial visual inspection of raw materials for signs of damage, contamination, or packaging integrity issues.
4.2.2 Check for compliance with labeling requirements, including batch numbers, expiration dates, and supplier information.
4.2.3 Reject materials that do not meet visual inspection criteria and initiate rejection procedures.
4.3 Sampling
4.3.1 Collect representative samples from each received lot based on sampling plans and procedures.
4.3.2 Use appropriate sampling tools and techniques to ensure sample integrity and representativeness.
4.3.3 Label samples accurately with identification information and transfer them to the QC laboratory for testing.
4.4 Testing
4.4.1 Perform quality control tests on raw materials according to approved test methods and specifications.
4.4.2 Conduct tests such as identity testing, assay, impurities, microbial limits, and any other relevant tests based on material specifications.
4.4.3 Record test results accurately in designated test records or electronic systems.
4.5 Material Acceptance or Rejection
4.5.1 Evaluate test results against acceptance criteria defined in material specifications.
4.5.2 Accept materials that meet all specifications and release them for use in production.
4.5.3 Reject materials that fail to meet specifications and initiate rejection procedures, including notification to suppliers.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
6) Documents, if any
Raw Material Specifications
Purchase Orders and Shipping Documents
Inspection and Testing Records
7) Reference, if any
USP (United States Pharmacopeia) Chapter on Pharmaceutical Excipients
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0
