facility must be subjected to thorough inspection and documentation. This includes verifying the quantity, integrity of packaging, and cross-referencing with purchase orders and supplier documentation.

4.1.1 Delivery and Unloading

• 4.1.1.1 Ensure that delivery trucks are properly sealed and intact before unloading. If seals are broken or appear tampered with, report immediately to the QA department.
• 4.1.1.2 Unload materials with care to avoid damage to packaging, ensuring that forklifts and other handling equipment are used appropriately.
• 4.1.1.3 Transfer materials to the designated quarantine area for further inspection.

4.1.2 Inspection of Raw Materials

Once materials are in the quarantine area, they must be inspected before being moved to approved storage areas. The inspection process ensures the material’s physical integrity and alignment with the accompanying documentation.

• 4.1.2.1 Verify that all packages are undamaged, clean, and dry. Damaged materials should be isolated and reported to the QA team.
• 4.1.2.2 Cross-check the supplier documentation, including the Certificate of Analysis (COA), material name, batch number, and expiration date, against internal records and the purchase order.
• 4.1.2.3 Ensure that each package is labeled with the appropriate identification code, batch number, and storage conditions (e.g., “store in a cool, dry place”).
• 4.1.2.4 Record the receipt and inspection details in the Raw Material Receipt Log (Annexure 1).

4.1.3 Quality Control Testing

Before any raw material is approved for production use, it must undergo testing by the QC department. The QC team is responsible for verifying the identity, purity, and potency of the raw material.

• 4.1.3.1 Select samples from each batch of material and submit them to the QC laboratory for analysis.
• 4.1.3.2 The QC team will perform tests in accordance with the relevant pharmacopoeial or in-house specifications.
• 4.1.3.3 Once testing is complete, the QC team will either approve or reject the material based on compliance with the required standards. Approved materials will be labeled accordingly and moved to the approved storage area, while rejected materials must be quarantined and returned to the supplier or disposed of as per SOP.

4.2 Storage of Raw Materials

Proper storage of raw materials is critical to maintaining their quality and ensuring they are suitable for use in liposome and emulsion formulations. Different materials may have different storage requirements, including temperature, humidity, and protection from light. These must be adhered to rigorously.

4.2.1 Environmental Controls

• 4.2.1.1 Storage conditions must be continuously monitored. Materials that require cold storage should be kept in temperature-controlled rooms or refrigerators, with daily temperature logs maintained.
• 4.2.1.2 Temperature-sensitive materials should be stored at 2°C-8°C, or as specified by the supplier. Non-temperature-sensitive materials should be stored at room temperature, typically 15°C-25°C, with humidity controls where necessary.
• 4.2.1.3 Ensure materials are stored in clean, dry areas to avoid contamination from dust, pests, or moisture.

4.2.2 Material Segregation

• 4.2.2.1 Raw materials should be segregated based on their chemical and physical properties. For instance, volatile materials should be stored separately from hygroscopic (moisture-sensitive) materials.
• 4.2.2.2 Store materials that are incompatible with each other in separate areas to prevent cross-contamination or reactive incidents.
• 4.2.2.3 Label shelves and storage areas clearly to avoid mix-ups and misidentification.

4.2.3 Inventory Management

• 4.2.3.1 Use a First In, First Out (FIFO) or First Expired, First Out (FEFO) system to manage inventory and ensure that materials are used before their expiration dates.
• 4.2.3.2 Perform regular stock checks to ensure that all materials are accounted for and in good condition.
• 4.2.3.3 Document storage conditions and inventory movements in the Raw Material Storage Log (Annexure 2).

5) Abbreviations, if any

• COA: Certificate of Analysis
• FIFO: First In, First Out
• QC: Quality Control
• FEFO: First Expired, First Out
• MSDS: Material Safety Data Sheet

6) Documents, if any

• Raw Material Receipt Log (Annexure 1)
• Raw Material Storage Log (Annexure 2)
• Certificate of Analysis (COA)

7) References, if any

• International Conference on Harmonisation (ICH) Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• FDA Code of Federal Regulations (CFR) 21 Part 211

8) SOP Version

Version 1.0

Annexure

Annexure 1: Raw Material Receipt Log Template

  

    
Date
    
Material Name
    
Batch No.
    
Supplier
    
Condition
    
Operator Initials
  
  

    
DD/MM/YYYY
    
Material Name
    
Batch Number
    
Supplier Name
    
Good/Damaged
    
Operator Initials
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Annexure 2: Raw Material Storage Log Template

  

    
Date
    
Material Name
    
Batch No.
    
Storage Condition
    
Location
    
Operator Initials
  
  

    
DD/MM/YYYY
    
Material Name
    
Batch Number
    
Temperature/Humidity
    
Storage Area
    
Operator Initials