SOP for Raw Material Receipt, Identification, and Storage for Lyophilized Products

Standard Operating Procedure for Handling Raw Materials for Lyophilized Products

1) Purpose

The purpose of this SOP is to define the procedure for the receipt, identification, and storage of raw materials required for lyophilized products. This SOP ensures the quality and integrity of the raw materials during storage and prior to usage in production, adhering to Good Manufacturing Practices (GMP).

2) Scope

This SOP applies to all personnel involved in receiving, identifying, and storing raw materials used in the manufacturing of lyophilized pharmaceutical products, including operators, warehouse staff, and quality assurance teams.

3) Responsibilities

Operators: Responsible for proper receipt and storage of materials according to the guidelines.
Quality Assurance (QA): Ensures that raw materials meet quality standards and verifies documentation.
Maintenance Team: Maintains storage conditions and equipment functionality for material handling.

4) Procedure

4.1 Receipt of Raw Materials

Upon receipt of raw materials, the following steps must be followed:

4.1.1 Inspection of Delivery

4.1.1.1 Inspect the delivery vehicle for cleanliness and integrity of packaging.
4.1.1.2 Check the accompanying documentation, such as Certificates of Analysis (CoA) and delivery notes.
4.1.1.3 Ensure that materials are not damaged or compromised during transit.

4.1.2 Verification and Identification

4.1.2.1 Verify the quantity and quality of the materials against the purchase order.
4.1.2.2 Label all incoming materials with a unique identification code that includes batch number, material name, and receipt date.
4.1.2.3 Record all relevant details in the raw material logbook.

4.2 Storage of Raw Materials

4.2.1 Storage Conditions

4.2.1.1 Store raw materials in designated areas, separated by type and status (quarantine, approved, rejected).
4.2.1.2 Maintain storage conditions as per the manufacturer’s recommendations (e.g., temperature and humidity).
4.2.1.3 Ensure that sensitive materials such as lyophilization agents are stored in temperature-controlled environments.

4.2.2 Inventory Control

4.2.2.1 Use a first-expiry-first-out (FEFO) system to manage inventory.
4.2.2.2 Keep a digital log of stock levels, including material receipt dates and batch numbers.
4.2.2.3 Regularly audit and reconcile inventory to avoid stock discrepancies.

4.3 Handling and Movement of Raw Materials

4.3.1 Handling Procedures

4.3.1.1 Use appropriate personal protective equipment (PPE) when handling materials to avoid contamination.
4.3.1.2 Minimize material handling and transfer materials with appropriate tools (e.g., forklifts or pallet jacks).

4.3.2 Quarantine and Sampling

4.3.2.1 Place all incoming raw materials into quarantine storage until they are sampled and approved by the quality control team.
4.3.2.2 Sample materials as per the sampling plan and transfer samples to the quality control laboratory for testing.
4.3.2.3 Release or reject materials based on the results of quality control testing.

4.4 Documentation

All steps must be documented meticulously. The following documents should be filled out and verified at each stage:

4.4.1 Raw Material Receipt Log
4.4.2 Material Identification and Labeling Records
4.4.3 Storage Condition Monitoring Logs

5) Abbreviations, if any

GMP: Good Manufacturing Practices
CoA: Certificate of Analysis
QA: Quality Assurance

6) Documents, if any

Raw Material Receipt Log
Material Identification and Labeling Record
Storage Condition Monitoring Log

7) References, if any

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
World Health Organization (WHO) Good Manufacturing Practices for Pharmaceutical Products.

8) SOP Version

Version 1.0

Annexure

Raw Material Receipt Logbook Template


  
    Date
    Material Name
    Batch No.
    Supplier
    Quantity
    Receipt Condition
    Operator Initials
    QA Approval
  
  
    DD/MM/YYYY
    Material Name
    Batch Number
    Supplier Name
    Quantity in kg/liters
    Good/Damaged
    Operator Name
    QA Initials

Date	Material Name	Batch No.	Supplier	Quantity	Receipt Condition	Operator Initials	QA Approval
DD/MM/YYYY	Material Name	Batch Number	Supplier Name	Quantity in kg/liters	Good/Damaged	Operator Name	QA Initials

Material Identification and Labeling Record Template


  
    Material Name
    Batch No.
    Receipt Date
    Label Generated
    Label Approved by QA
    Remarks
  
  
    Material Name
    Batch Number
    DD/MM/YYYY
    Yes/No
    Yes/No
    Comments, if any