Raw Material Handling for Liposome and Emulsion Formulations

1) Purpose

The purpose of this SOP is to outline the process for the receipt, identification, and storage of raw materials used in the preparation of liposome and emulsion formulations to ensure quality and compliance with regulatory guidelines.

2) Scope

This SOP applies to all personnel involved in the receipt, identification, and storage of raw materials used in liposome and emulsion formulation manufacturing at the facility.

3) Responsibilities

• Operators: Responsible for receiving, identifying, and storing raw materials following this SOP.
• QA Team: Responsible for verifying raw material identification and ensuring proper documentation.
• Maintenance Team: Responsible for ensuring storage areas are maintained at appropriate conditions for raw material storage.

4) Procedure

4.1 Receipt of Raw Materials

All raw materials arriving at the facility must be properly logged, inspected, and documented.

4.1.1 Inspection

Upon receipt, raw material packages must be inspected for integrity, damage, and compliance with the supplier’s specifications. The following steps outline the inspection process:

• 4.1.1.1 Check for any damage to the exterior packaging.
• 4.1.1.2 Verify that the supplier information and batch number match the purchase order.
• 4.1.1.3 Ensure that the material is stored under appropriate conditions (e.g., temperature-controlled, moisture-sensitive) as per the material safety data sheet (MSDS).
• 4.1.1.4 Record the condition of the materials in the raw material logbook (Annexure 1).

4.2 Identification of Raw Materials

Each raw material must be accurately identified before use in the formulation process:

• 4.2.1 Cross-check the Certificate of Analysis (COA) provided by the supplier against internal specifications.
• 4.2.2 Each raw material container must be labeled with the appropriate identification number, batch number, and expiration date.
• 4.2.3 Samples of each batch of raw material must be sent to the quality control (QC) department for further analysis and approval before use.

4.3 Storage of Raw Materials

Once identified and approved, raw materials should be stored according to the following guidelines:

• 4.3.1 Ensure that all storage conditions meet the specified temperature, humidity, and light requirements for each material.
• 4.3.2 Use a First In, First Out (FIFO) system to rotate stock, ensuring older materials are used before newer ones.
• 4.3.3 Any materials that do not meet specifications should be quarantined and labeled accordingly.
• 4.3.4 Ensure that material-specific storage areas are clearly labeled and separated to avoid cross-contamination.
• 4.3.5 Conduct regular audits of storage conditions and material stock to ensure compliance with standard procedures.

5) Abbreviations, if any

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

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