Standard Operating Procedure for Mixing and Homogenization Techniques in Lyophilized Formulations

1) Purpose

This SOP describes the methods and techniques for mixing and homogenizing components in lyophilized formulations to ensure uniformity and proper dispersion of active ingredients and excipients.

2) Scope

This SOP applies to the formulation development team, production operators, and QA staff involved in the mixing and homogenization of raw materials in lyophilized formulations.

3) Responsibilities

• Operators: Responsible for following the mixing and homogenization procedures as outlined in the BMR.
• Formulation Scientists: Responsible for selecting appropriate mixing methods based on formulation characteristics.
• QA: Responsible for verifying process parameters and documenting results.

4) Procedure

4.1 Equipment Setup

• 4.1.1 Ensure that all equipment (e.g., mechanical mixers, homogenizers) is cleaned and calibrated before use.
• 4.1.2 Set up the equipment in the designated area following safety protocols.

4.2 Mixing Procedure

4.2.1 Weighing and Addition of Materials

• 4.2.1.1 Weigh all raw materials as per the formulation instructions and add them to the mixing vessel.

4.2.2 Mixing Process

• 4.2.2.1 Use the specified mixing speed and duration as per the formulation record.
• 4.2.2.2 Monitor the temperature during mixing to avoid overheating, which may affect the stability of the components.

4.3 Homogenization Process

4.3.1 Homogenization Settings

• 4.3.1.1 Homogenize the solution to achieve uniform particle size distribution as per the formulation requirements.
• 4.3.1.2 Verify the homogenization speed, pressure, and time based on the specific formulation needs.

4.3.2 Post-Homogenization Checks

• 4.3.2.1 After homogenization, verify the solution’s viscosity, clarity, and consistency.
• 4.3.2.2 Document the homogenization parameters and results.

4.4 Cleaning

• 4.4.1 After use, clean the mixing and homogenization equipment as per the cleaning SOP to avoid cross-contamination between batches.

5) Abbreviations

• BMR: Batch Manufacturing Record

6) Documents

• Mixing and Homogenization Logbook

7) References

• Industry guidelines for mixing and homogenization in pharmaceutical manufacturing.

8) SOP Version

Version 1.0

Annexure

Mixing and Homogenization Logbook Template

  

    
Date
    
Formulation Name
    
Batch No.
    
Mixing Time
    
Homogenization Settings
    
Operator Initials
    
QA Verification
  
  

    
DD/MM/YYYY
    
Formulation Name
    
Batch Number
    
Mixing Time in minutes
    
Homogenization Speed/Pressure
    
Operator Name
    
QA Initials
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Preparation of API Solutions for Lyophilization

1) Purpose

This SOP outlines the procedures for preparing Active Pharmaceutical Ingredient (API) solutions to be used in lyophilized formulations, ensuring accurate concentration and uniformity prior to lyophilization.

2) Scope

This SOP applies to formulation scientists, production operators, and quality assurance teams involved in the preparation of API solutions for lyophilized products.

3) Responsibilities

• Formulation Scientists: Responsible for specifying the concentration and composition of the API solution.
• Operators: Responsible for preparing the API solution according to the Batch Manufacturing Record (BMR).
• QA: Responsible for verifying solution preparation and documentation.

4) Procedure

4.1 Preparation of API Solution

4.1.1 Equipment Setup

• 4.1.1.1 Ensure that all equipment used for solution preparation (stirrers, balances, etc.) is cleaned, sanitized, and calibrated.
• 4.1.1.2 Use sterilized containers for API solution preparation.

4.1.2 API Weighing and Solution Preparation

• 4.1.2.1 Weigh the required amount of API using a calibrated balance according to the formulation instructions.
• 4.1.2.2 Slowly add the weighed API to a designated volume of solvent (e.g., water for injection, WFI).
• 4.1.2.3 Stir the solution using a mechanical stirrer until the API is completely dissolved, ensuring no visible particulates remain.

4.1.3 pH Adjustment (if applicable)

• 4.1.3.1 Measure the pH of the solution using a calibrated pH meter.
• 4.1.3.2 Adjust the pH by adding a small amount of acid or base if specified in the formulation instructions.

4.2 Filtration and Storage

4.2.1 Filtration

• 4.2.1.1 Filter the prepared API solution using a sterile filtration system (e.g., 0.22-micron filter) to remove any particulates.

4.2.2 Storage

• 4.2.2.1 Transfer the filtered solution into sterilized, labeled containers.
• 4.2.2.2 Store the solution under conditions specified by the formulation (e.g., refrigerated or ambient temperature).

4.3 Documentation

All steps involved in API solution preparation, including API weight, solvent used, and pH readings, must be documented in the API Solution Preparation Logbook.

5) Abbreviations

• API: Active Pharmaceutical Ingredient
• BMR: Batch Manufacturing Record
• WFI: Water for Injection

6) Documents

• API Solution Preparation Logbook

7) References

• Pharmacopoeial guidelines for API solution preparation (e.g., USP, EP)

8) SOP Version

Version 1.0

Annexure

API Solution Preparation Logbook Template

  

    
Date
    
API Name
    
Batch No.
    
Concentration
    
pH
    
Operator Initials
    
QA Verification
  
  

    
DD/MM/YYYY
    
API Name
    
Batch Number
    
Concentration (mg/mL)
    
pH Value
    
Operator Name
    
QA Initials
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Incorporation of Stabilizers in Lyophilized Formulations

1) Purpose

This SOP outlines the process for selecting and incorporating stabilizers into lyophilized formulations, ensuring product stability during and after lyophilization.

2) Scope

This SOP applies to the formulation team, production operators, and QA staff responsible for the incorporation of stabilizers in lyophilized formulations.

3) Responsibilities

• Formulation Scientists: Responsible for selecting the stabilizer appropriate for the formulation.
• Operators: Responsible for accurately incorporating the stabilizer as per the BMR.
• QA: Responsible for verifying stabilizer addition and related documentation.

4) Procedure

4.1 Selection of Stabilizers

4.1.1 Criteria for Selection

• 4.1.1.1 Stabilizers should protect the API and excipients during the drying process.
• 4.1.1.2 Stabilizers such as sugars (e.g., trehalose, sucrose), amino acids (e.g., glycine), and polymers are commonly used.

4.2 Incorporation of Stabilizers

4.2.1 Weighing and Dispensing

• 4.2.1.1 Weigh the stabilizer as per the formulation guidelines.
• 4.2.1.2 Dispense the stabilizer into the formulation solution before lyophilization.

4.2.2 Mixing

• 4.2.2.1 Ensure the stabilizer is completely dissolved by stirring the solution appropriately.

5) Abbreviations

• BMR: Batch Manufacturing Record

6) Documents

• Stabilizer Addition Logbook

7) References

• Research papers and articles on stabilizers used in lyophilization

8) SOP Version

Version 1.0

Annexure

Stabilizer Addition Logbook Template

  

    
Date
    
Stabilizer Name
    
Batch No.
    
Quantity
    
Operator Initials
    
QA Verification
  
  

    
DD/MM/YYYY
    
Stabilizer Name
    
Batch Number
    
Quantity in grams
    
Operator Name
    
QA Initials
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Use of Cryoprotectants in Lyophilized Products

1) Purpose

The purpose of this SOP is to establish the procedures for selecting and incorporating cryoprotectants into lyophilized formulations, ensuring the protection of active ingredients during the freezing and drying stages.

2) Scope

This SOP applies to all staff involved in the formulation and production of lyophilized products, including operators, formulation scientists, and QA teams.

3) Responsibilities

• Formulation Scientists: Responsible for selecting suitable cryoprotectants.
• Operators: Responsible for accurate incorporation of cryoprotectants as per the Batch Manufacturing Record (BMR).
• QA: Responsible for verifying cryoprotectant use and documentation.

4) Procedure

4.1 Selection of Cryoprotectants

Selection of cryoprotectants is based on the product’s stability and the sensitivity of the active pharmaceutical ingredient (API) during the freezing and lyophilization processes.

4.1.1 Criteria for Selection

• 4.1.1.1 Choose cryoprotectants that are compatible with the formulation and do not interfere with the API.
• 4.1.1.2 Typical cryoprotectants include sugars (e.g., sucrose, trehalose) and polyols (e.g., mannitol, glycerol).

4.2 Incorporation of Cryoprotectants

4.2.1 Weighing and Dispensing

• 4.2.1.1 Weigh the cryoprotectants as specified in the BMR using calibrated equipment.
• 4.2.1.2 Dispense the cryoprotectant into the formulation solution before the freezing step.

4.2.2 Mixing Procedure

• 4.2.2.1 Ensure complete dissolution of the cryoprotectant by stirring or using a homogenizer if necessary.
• 4.2.2.2 Ensure the solution is clear with no visible particulates.

4.3 Documentation

All cryoprotectant additions, including weights and batch numbers, must be recorded in the Cryoprotectant Logbook and verified by QA.

5) Abbreviations

• BMR: Batch Manufacturing Record
• QA: Quality Assurance

6) Documents

• Cryoprotectant Logbook

7) References

• Scientific literature on the use of cryoprotectants in lyophilized products

8) SOP Version

Version 1.0

Annexure

Cryoprotectant Logbook Template

  

    
Date
    
Cryoprotectant Name
    
Batch No.
    
Quantity
    
Operator Initials
    
QA Verification
  
  

    
DD/MM/YYYY
    
Cryoprotectant Name
    
Batch Number
    
Quantity in grams
    
Operator Name
    
QA Initials
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Preparation of Buffers for Lyophilized Formulations

1) Purpose

This SOP outlines the process for preparing buffers used in lyophilized formulations to ensure proper pH and composition for the stability of active ingredients throughout the lyophilization process.

2) Scope

This SOP applies to all staff involved in buffer preparation, including formulation scientists, production operators, and QA teams in the production of lyophilized products.

3) Responsibilities

• Operators: Responsible for buffer preparation according to the Batch Manufacturing Record (BMR).
• Quality Control (QC): Responsible for pH verification and ensuring buffer quality.
• QA: Responsible for monitoring and verifying all buffer preparation documentation.

4) Procedure

4.1 Buffer Preparation

4.1.1 Equipment Setup

• 4.1.1.1 Calibrate the pH meter before use.
• 4.1.1.2 Ensure that all equipment used for preparation is sanitized and verified as clean.
• 4.1.1.3 Prepare all required materials as outlined in the BMR.

4.1.2 Buffer Component Preparation

• 4.1.2.1 Measure out the required quantities of each component using a calibrated scale.
• 4.1.2.2 Transfer the components into deionized or distilled water, as per the formulation.
• 4.1.2.3 Stir the solution until all components are completely dissolved.

4.1.3 pH Adjustment

• 4.1.3.1 Measure the pH of the buffer using the calibrated pH meter.
• 4.1.3.2 Adjust the pH by adding small amounts of acid or base solutions, as required, to achieve the desired pH.
• 4.1.3.3 Recheck the pH until the specified range is achieved.

4.1.4 Filtration

• 4.1.4.1 Filter the buffer solution using a sterile filtration system to remove any particulate matter.
• 4.1.4.2 Store the buffer in clean, labeled containers, indicating the pH, batch number, and preparation date.

4.2 Documentation

All steps, including buffer component quantities, pH readings, and adjustments, must be documented in the Buffer Preparation Logbook.

5) Abbreviations, if any

• BMR: Batch Manufacturing Record
• QC: Quality Control
• QA: Quality Assurance

6) Documents, if any

• Buffer Preparation Logbook

7) References, if any

• USP Guidelines for Buffer Preparation

8) SOP Version

Version 1.0

Annexure

Buffer Preparation Logbook Template

  

    
Date
    
Buffer Name
    
Batch No.
    
pH
    
Operator Initials
    
QC Verification
  
  

    
DD/MM/YYYY
    
Buffer Name
    
Batch Number
    
pH Value
    
Operator Name
    
QC Initials
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Use of Cryoprotectants in Lyophilized Formulations

1) Purpose

The purpose of this SOP is to establish guidelines for selecting and incorporating cryoprotectants into lyophilized formulations to protect biological molecules during the freezing and drying processes.

2) Scope

This SOP applies to the formulation development team, production operators, and QA teams involved in lyophilized products that require the use of cryoprotectants.

3) Responsibilities

• Formulation Scientists: Responsible for selecting appropriate cryoprotectants based on product characteristics.
• Operators: Responsible for incorporating cryoprotectants into formulations as per the batch manufacturing record (BMR).
• QA: Responsible for verifying the incorporation process and ensuring the cryoprotectant addition is documented.

4) Procedure

4.1 Selection of Cryoprotectants

4.1.1 Criteria for Selection

• 4.1.1.1 Select cryoprotectants that are non-toxic and do not interfere with the lyophilization process.
• 4.1.1.2 Ensure that cryoprotectants provide adequate protection against freezing damage for sensitive molecules.
• 4.1.1.3 Common cryoprotectants include sugars like sucrose, trehalose, and amino acids like glycine.

4.2 Incorporation of Cryoprotectants

4.2.1 Weighing and Dispensing

• 4.2.1.1 Weigh the cryoprotectants accurately as per the formulation specifications in the BMR.
• 4.2.1.2 Dispense the cryoprotectant into the formulation solution prior to freezing.

4.2.2 Mixing Procedure

• 4.2.2.1 Stir the solution containing cryoprotectants until they are fully dissolved.
• 4.2.2.2 Ensure no particles are visible in the solution, which could indicate improper dissolution.

4.2.3 pH Adjustment

• 4.2.3.1 If necessary, adjust the pH of the solution after the addition of cryoprotectants to maintain product stability.

5) Abbreviations

• BMR: Batch Manufacturing Record

6) Documents

• Cryoprotectant Preparation Logbook

7) References

• Research articles and guidelines on cryoprotectants in lyophilization

8) SOP Version

Version 1.0

Annexure

Cryoprotectant Preparation Logbook Template

  

    
Date
    
Cryoprotectant
    
Batch No.
    
Quantity Used
    
Operator Initials
    
QA Verification
  
  

    
DD/MM/YYYY
    
Cryoprotectant Name
    
Batch Number
    
Quantity in Grams
    
Operator Name
    
QA Initials
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Buffer Preparation for Lyophilized Formulations

1) Purpose

This SOP outlines the steps for preparing buffers used in lyophilized formulations, ensuring the correct pH and composition to maintain the stability of active ingredients during lyophilization.

2) Scope

This SOP applies to all personnel involved in the preparation of buffers for lyophilized products, including production and quality teams.

3) Responsibilities

• Production Operators: Responsible for preparing the buffers according to the batch manufacturing record (BMR).
• QA: Responsible for verifying buffer composition and pH.

4) Procedure

4.1 Buffer Preparation

4.1.1 Raw Materials and Equipment

• 4.1.1.1 Ensure all raw materials for buffer preparation meet the specifications provided in the BMR.
• 4.1.1.2 Calibrate pH meters and other equipment.

4.1.2 Mixing Procedure

• 4.1.2.1 Measure out the required quantities of buffer components using calibrated equipment.
• 4.1.2.2 Add the components to deionized water and stir until dissolved.
• 4.1.2.3 Adjust the pH as required using acid or base solutions.

5) Abbreviations

• BMR: Batch Manufacturing Record

6) Documents

• Buffer Preparation Logbook

7) References

• Buffer preparation standards in pharmacopeia

8) SOP Version

Version 1.0

Annexure

Buffer Preparation Logbook Template

  

    
Date
    
Buffer Name
    
Batch No.
    
pH
    
Operator Initials
    
QA Verification
  
  

    
DD/MM/YYYY
    
Buffer Name
    
Batch Number
    
pH Value
    
Operator Name
    
QA Initials
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Solvent Selection and Preparation for Lyophilized Formulations

1) Purpose

This SOP defines the procedure for selecting and preparing solvents used in lyophilized formulations, ensuring the solvents meet the required specifications for product quality and stability.

2) Scope

This SOP applies to the selection and preparation of solvents by formulation scientists, operators, and QA teams involved in lyophilized product development.

3) Responsibilities

• Operators: Responsible for preparing solvents as per the procedure.
• Formulation Scientists: Responsible for selecting the appropriate solvent for each formulation.
• QA: Responsible for verifying solvent quality and process documentation.

4) Procedure

4.1 Solvent Selection

4.1.1 Criteria for Solvent Selection

• 4.1.1.1 The solvent should be non-reactive with active pharmaceutical ingredients (API).
• 4.1.1.2 The solvent should facilitate efficient lyophilization.
• 4.1.1.3 Ensure the solvent is compatible with the lyophilization equipment.
• 4.1.1.4 The solvent must meet pharmacopoeial standards (e.g., USP, EP).

4.2 Solvent Preparation

4.2.1 Equipment Preparation

• 4.2.1.1 Clean and calibrate measuring equipment such as volumetric flasks and graduated cylinders.
• 4.2.1.2 Ensure that containers are properly labeled and sanitized.

4.2.2 Solvent Measurement

• 4.2.2.1 Measure the required quantity of solvent as per the formulation guidelines.
• 4.2.2.2 Verify the measurements with a second operator for accuracy.

4.2.3 Mixing Procedure

• 4.2.3.1 If necessary, mix the solvent with other excipients or solvents in the appropriate ratio.
• 4.2.3.2 Use mechanical stirrers if the solvent requires agitation.

5) Abbreviations

• USP: United States Pharmacopeia
• EP: European Pharmacopeia
• API: Active Pharmaceutical Ingredient

6) Documents

• Solvent Preparation Logbook

7) References

• USP, EP standards for solvents

8) SOP Version

Version 1.0

Annexure

Solvent Preparation Logbook Template

  

    
Date
    
Solvent
    
Batch No.
    
Measured Quantity
    
Operator Initials
    
QA Verification
  
  

    
DD/MM/YYYY
    
Solvent Name
    
Batch Number
    
Quantity in Liters
    
Operator Name
    
QA Initials
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Weighing and Dispensing of Raw Materials for Lyophilization

1) Purpose

The purpose of this SOP is to establish the process for weighing and dispensing raw materials used in lyophilized product formulations, ensuring accuracy, consistency, and traceability of material usage as per Good Manufacturing Practices (GMP).

2) Scope

This SOP applies to the operators, quality control, and warehouse staff responsible for weighing and dispensing raw materials required in the lyophilization process, from receipt to production usage.

3) Responsibilities

• Operators: Responsible for accurate weighing and dispensing of raw materials according to batch records.
• Quality Assurance (QA): Responsible for verifying weights and ensuring the proper documentation.
• Warehouse Staff: Responsible for the safe storage and handling of raw materials before and after dispensing.

4) Procedure

4.1 Preparation for Weighing

The following steps are to be performed before the weighing process begins:

4.1.1 Material and Equipment Setup

• 4.1.1.1 Ensure all equipment, including balances, is calibrated and functional.
• 4.1.1.2 Check that the area is clean and ready for material dispensing.
• 4.1.1.3 Review the batch manufacturing record (BMR) for the required materials and quantities.
• 4.1.1.4 Wear appropriate personal protective equipment (PPE) before handling materials.

4.1.2 Raw Material Retrieval

• 4.1.2.1 Retrieve materials from storage based on the batch requirements.
• 4.1.2.2 Verify that the batch number and identification code match the batch manufacturing record (BMR).
• 4.1.2.3 Bring materials to the designated dispensing area in labeled containers.

4.2 Weighing Process

4.2.1 Weighing Procedure

• 4.2.1.1 Zero the balance before placing any material on it.
• 4.2.1.2 Place the material in a clean container and record the weight on the balance display.
• 4.2.1.3 Ensure that the weight matches the required quantity as per the BMR, considering acceptable tolerances.
• 4.2.1.4 For multiple components, weigh each material separately and record the weights in the Weighing Logbook.

4.2.2 Cross-Verification

• 4.2.2.1 After weighing, the operator must sign off on the recorded weight in the logbook.
• 4.2.2.2 A QA personnel should verify and countersign the weight documentation.
• 4.2.2.3 Any discrepancies must be reported immediately, and materials should be re-weighed if necessary.

4.3 Dispensing Process

4.3.1 Dispensing to Production

• 4.3.1.1 Once weighed, dispense the material into the production container, ensuring it is clearly labeled with the batch number and material name.
• 4.3.1.2 Ensure that no cross-contamination occurs during the transfer of materials.
• 4.3.1.3 If partial quantities of raw materials are required, ensure that remaining materials are resealed and stored appropriately.

4.3.2 Documentation and Labeling

• 4.3.2.1 Record the dispensed material, batch number, and weight in the Dispensing Logbook.
• 4.3.2.2 All containers should be clearly labeled with the material name, batch number, and quantity.
• 4.3.2.3 QA must verify the labels and documentation before the materials are transferred to the production area.

4.4 Cleaning and Storage Post-Dispensing

Following the dispensing process, the weighing and dispensing area should be cleaned and materials stored as follows:

• 4.4.1 Clean the weighing area and equipment after each use to prevent cross-contamination.
• 4.4.2 Return any unused raw materials to their designated storage location, ensuring they are sealed and labeled properly.
• 4.4.3 Document the cleaning activities in the cleaning logbook for the weighing area and equipment.

5) Abbreviations, if any

• BMR: Batch Manufacturing Record
• PPE: Personal Protective Equipment
• QA: Quality Assurance

6) Documents, if any

• Weighing Logbook
• Dispensing Logbook
• Cleaning Logbook

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

Weighing Logbook Template

  

    
Date
    
Material Name
    
Batch No.
    
Required Weight
    
Actual Weight
    
Operator Initials
    
QA Verification
  
  

    
DD/MM/YYYY
    
Material Name
    
Batch Number
    
Weight in grams/kg
    
Weight in grams/kg
    
Operator Name
    
QA Initials
  
  

    
 
    
 
    
 
    
 
    
 
    
 
    
 
  

Dispensing Logbook Template

  

    
Date
    
Material Name
    
Batch No.
    
Dispensed Quantity
    
Production Batch No.
    
Operator Initials
    
QA Verification
  
  

    
DD/MM/YYYY
    
Material Name
    
Batch Number
    
Quantity in grams/kg
    
Production Batch Number
    
Operator Name
    
QA Initials
  
  

    
 
    
 
    
 
    
 
    
 
    
 
    
 
  

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
  
  

    
 
    
 
    
 
    
 
    
 
    
 
    
 
    
 
  

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