against the purchase order to ensure the correct quantities and materials are received.

4.1.2 Documentation of Receipt

• 4.1.2.1 Record the details of the received materials in the raw materials receipt and inspection logbook, noting the date, time of receipt, material name, batch number, and supplier details.
• 4.1.2.2 Ensure that any discrepancies between the received materials and the purchase order are documented and communicated to QA for further investigation.

4.2 Material Identification

4.2.1 Labeling

• 4.2.1.1 Once materials are received, ensure that each container is labeled with the material name, batch number, and the date of receipt.
• 4.2.1.2 Labels should be resistant to smudging and should be clearly visible on each container.

4.2.2 Sampling

• 4.2.2.1 Prior to use, samples of raw materials should be taken for quality control (QC) testing to ensure compliance with specifications.
• 4.2.2.2 Sampling should be conducted in a controlled environment to avoid contamination. Follow the company’s sampling SOP for nanoparticle raw materials.

4.3 Storage of Raw Materials

4.3.1 Storage Conditions

• 4.3.1.1 Store all raw materials in designated storage areas that are maintained at the required environmental conditions, such as temperature and humidity.
• 4.3.1.2 Temperature-sensitive materials should be stored in refrigerated or frozen storage as per their specific requirements. Monitor storage conditions regularly.

4.3.2 Stock Rotation

• 4.3.2.1 Implement a First-In-First-Out (FIFO) system to ensure older stock is used before newer stock.
• 4.3.2.2 Regularly inspect the stored materials for any signs of degradation, contamination, or expiration. Dispose of any materials that do not meet quality standards in accordance with company disposal procedures.

4.4 Safety Considerations

4.4.1 Personal Protective Equipment (PPE)

• 4.4.1.1 Operators handling raw materials must wear appropriate PPE, including gloves, masks, and protective clothing, to prevent contamination of the materials and ensure personal safety.
• 4.4.1.2 Follow all safety guidelines for handling hazardous or sensitive materials as per the material safety data sheet (MSDS) associated with each raw material.

4.4.2 Handling Procedures

• 4.4.2.1 Use appropriate equipment to handle large or heavy containers to prevent injury and spillage. Ensure that all raw materials are handled with care to avoid damage to the packaging or contamination of the product.
• 4.4.2.2 If any raw material spills occur, follow the company’s spill management SOP to contain and clean the spill immediately.

5) Abbreviations, if any

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• PPE: Personal Protective Equipment

6) Documents, if any

• Raw Material Receipt and Inspection Logbook

7) References, if any

• Good Manufacturing Practice (GMP) Guidelines for Pharmaceuticals
• ISO 9001:2015 Quality Management Systems Requirements

8) SOP Version

Version 1.0

Annexure

Raw Material Receipt and Inspection Logbook Template

  

    
Date
    
Material Name
    
Batch Number
    
Quantity Received
    
Supplier
    
Inspector Initials
    
Remarks
  
  

    
DD/MM/YYYY
    
Material Name
    
Batch Number
    
Quantity in kg
    
Supplier Name
    
Inspector Name
    
Inspection results and remarks