the validation process, ensuring that all tasks are carried out accurately and efficiently.
Validation Team: Composed of technical personnel who design the validation protocol, execute the validation runs, and analyze the results.
Maintenance Personnel: Ensures that all equipment used in the manufacturing process is properly calibrated and functioning correctly.

4) Procedure

The following steps should be followed for the process validation of modified-release tablet manufacturing:

1. Preparation for Validation:
1.1 Review batch records to identify critical process parameters (CPPs) for each stage of the modified-release tablet manufacturing process.
1.2 Develop a process validation protocol that includes objectives, scope, equipment, and personnel involved in the validation process.
1.3 Ensure that all equipment used, including mixing machines, tablet presses, coating machines, and release testing apparatus, are properly calibrated and operational.

2. Validation Protocol:
2.1 Protocol Design: The validation protocol should be based on the formulation of the modified-release tablet and the specific manufacturing process.
2.2 Defining Acceptance Criteria: Establish acceptance criteria for critical parameters such as tablet hardness, weight uniformity, content uniformity, release rate, and coating integrity.
2.3 Risk Assessment: Conduct a risk assessment to identify critical quality attributes (CQAs) and critical process parameters (CPPs) for the modified-release tablet. This ensures that the process is robust and capable of producing consistent and reliable results.

3. Execution of Validation:
3.1 Mixing: Validate the mixing process to ensure uniform distribution of active ingredients and excipients. Control mixing time, speed, and temperature to achieve the desired homogeneity.
3.2 Granulation: For modified-release tablets requiring granulation, validate the granulation process, ensuring the granule size, moisture content, and uniformity are within specifications.
3.3 Compression: Validate the tablet compression process, ensuring tablet weight, thickness, and hardness are consistent with predetermined specifications.
3.4 Coating: Validate the tablet coating process to ensure uniform film thickness and proper adhesion of the coating. Validate both immediate-release and modified-release coatings as applicable.
3.5 Release Testing: Perform in vitro dissolution testing to validate the modified-release profile. Ensure the tablet releases the active ingredient at the prescribed rate over the appropriate time period according to the drug release specification.

4. Documentation and Reporting:
4.1 Record all data during the validation process, including batch records, equipment logs, process parameters, and testing results.
4.2 Ensure all forms, reports, and certificates are completed and signed by the responsible personnel.
4.3 Perform statistical analysis on the collected data to assess the process capability and confirm that the process meets the acceptance criteria.
4.4 Prepare a final validation report summarizing the results, including any deviations from the acceptance criteria and corrective actions taken, if necessary.

5. Revalidation:
5.1 Revalidate the process if there are any changes to the formulation, raw materials, equipment, or critical process parameters.
5.2 Periodically revalidate the process to ensure continued compliance with regulatory requirements and consistent product quality.

5) Abbreviations

• QA: Quality Assurance
• CPP: Critical Process Parameter
• CQA: Critical Quality Attribute
• SOP: Standard Operating Procedure

6) Documents

• Process Validation Protocol
• Batch Production Records
• Equipment Calibration Logs
• Process Validation Reports
• Raw Material Certificates of Analysis
• Statistical Analysis Data

7) Reference

• International Council for Harmonisation (ICH) Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Process Validation
• ISO 9001: Quality Management Systems – Requirements

8) SOP Version

Version 1.0 – Effective Date: DD/MM/YYYY

Annexure

Template 1: Mixing Process Record

Date	Time	Operator Initials	Mixing Duration	Remarks
DD/MM/YYYY	HH:MM	Operator Name	Duration in minutes	Process completed as per SOP

Template 2: Compression Process Record

Batch No.	Compression Date	Tablet Weight	Tablet Thickness	Operator Initials	Supervisor Signature
Batch Number	DD/MM/YYYY	Weight in mg	Thickness in mm	Operator Name	Supervisor Name

Template 3: Coating Process Record

Batch No.	Coating Date	Coating Thickness	Coating Uniformity	Operator Initials	Supervisor Signature
Batch Number	DD/MM/YYYY	Thickness in microns	Pass/Fail	Operator Name	Supervisor Name

Template 4: Dissolution Testing Record

Batch No.	Test Date	Time Point	Cumulative Release (%)	Operator Initials
Batch Number	DD/MM/YYYY	Time (minutes)	Release in %	Operator Name

Template 5: Raw Material Certificate of Analysis

Material ID	Supplier	Batch No.	Test Result	Approved By
Material Number	Supplier Name	Batch Number	Test Result	QC Name

Template 6: Statistical Analysis Data

Sample ID	Test Type	Mean	Standard Deviation	Result
Sample Number	Test Name	Mean Value	Standard Deviation	Pass/Fail