Visual Inspection Procedures for Raw Materials
1) Purpose
The purpose of this SOP is to establish a standardized procedure for the visual inspection of incoming raw materials to identify signs of contamination, damage, or inconsistencies before their use in production.
2) Scope
This SOP applies to all incoming raw materials received at the pharmaceutical manufacturing facility.
3) Responsibilities
– QC personnel are responsible for conducting the visual inspection of raw materials.
– Warehouse personnel are responsible for notifying QC of incoming raw materials.
– QA personnel are responsible for reviewing and approving the inspection results.
4) Procedure
1. Preparation for Inspection
1.1. Ensure that the inspection area is clean and well-lit.
1.2. Gather necessary inspection tools, such as magnifying glasses, gloves, and documentation forms.
1.3. Wear appropriate personal protective equipment (PPE) as per safety guidelines.
2. Receiving Raw Materials
2.1. Upon arrival, check that the raw material containers are properly labeled with the supplier name, material name, batch number, and other relevant information.
2.2. Inspect the condition of the containers for any signs
3. Visual Inspection Criteria
3.1. Open the containers and inspect the raw materials for:
3.1.1. Signs of contamination (e.g., foreign particles, discoloration)
3.1.2. Physical damage (e.g., cracks, tears)
3.1.3. Consistency in appearance (e.g., color, texture)
3.2. Compare the raw materials against reference samples or specifications provided by the supplier.
4. Documentation
4.1. Record the results of the inspection on the raw material inspection form.
4.2. Include details such as batch number, supplier name, date of inspection, and any observations or anomalies.
4.3. Sign and date the inspection form.
5. Acceptance and Rejection
5.1. Accept the raw materials if they meet all specified criteria.
5.2. Reject the raw materials if they show signs of contamination, damage, or inconsistencies.
5.3. Notify the supplier of any rejected materials and document the rejection.
6. Storage of Accepted Materials
6.1. Store accepted raw materials in designated storage areas under appropriate conditions.
6.2. Ensure that all storage areas are labeled and organized to prevent mix-ups.
7. Corrective Actions
7.1. If raw materials are rejected, initiate a corrective action report.
7.2. Document all actions taken to address issues identified during the inspection.
5) Abbreviations, if any
– QC: Quality Control
– QA: Quality Assurance
– PPE: Personal Protective Equipment
6) Documents, if any
– Raw Material Inspection Form
– Corrective Action Report Form
7) Reference, if any
– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0