Standard Operating Procedure for Validating Tablet Manufacturing Process
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to provide clear guidelines for the process validation of tablet manufacturing. This SOP ensures that the manufacturing process consistently yields tablets that meet predetermined quality specifications. It outlines the validation steps to confirm that the tablet manufacturing process is robust, reproducible, and compliant with regulatory standards, guaranteeing product quality and safety.
2) Scope
This SOP is applicable to all tablet manufacturing processes within the facility, including formulation, mixing, granulation, drying, compression, and coating. It covers process validation for both new tablet formulations and those undergoing significant changes. The SOP is designed for use by quality assurance (QA), production teams, and technical personnel involved in the validation process.
3) Responsibilities
Operators: Responsible for executing the process validation steps in accordance with the approved protocol.
Quality Assurance (QA): Oversees and ensures that the process validation complies with this SOP and regulatory standards. QA verifies the documentation and approves the validation reports.
Production Supervisors: Supervises the validation process, ensuring its proper execution and providing necessary support to the operators.
Validation Team: A group of technical personnel responsible for designing
Maintenance Personnel: Ensures that the equipment used during validation is functioning properly and that all calibration procedures are in place.
4) Procedure
The following steps should be followed for the process validation of tablet manufacturing:
1. Preparation for Validation:
1.1 Review the batch records to identify the critical process parameters (CPPs) for each manufacturing step.
1.2 Develop a process validation protocol outlining objectives, scope, involved equipment, and personnel.
1.3 Ensure that all equipment is calibrated and operational before beginning the validation process.
2. Validation Protocol:
2.1 Protocol Design: The validation protocol should be based on the tablet formulation and process flow.
2.2 Defining Acceptance Criteria: Establish acceptance criteria for each stage of manufacturing, including blending, compression, and coating.
2.3 Risk Assessment: Conduct a risk assessment to determine critical quality attributes (CQAs) and corresponding critical process parameters (CPPs).
3. Execution of Validation:
3.1 Blending: Ensure uniformity in the powder blend using equipment like the V-blender or Ribbon blender. Control the blending time, speed, and temperature.
3.2 Granulation: For wet granulation, confirm the appropriate granulation fluid volume, granulation time, and moisture content.
3.3 Drying: Validate the drying parameters such as time, temperature, and humidity to achieve the target moisture content.
3.4 Compression: Perform tablet compression runs to ensure tablet uniformity in weight, hardness, and thickness. Validate that the tablet press is properly calibrated.
3.5 Coating: Validate the coating process by ensuring uniformity in film thickness and coating weight.
4. Documentation and Reporting:
4.1 Record all data during the validation process, including batch records, equipment logs, and relevant process parameters.
4.2 Ensure that all forms and reports are completed and signed by the responsible personnel.
4.3 Perform statistical analysis on the collected data to assess process capability.
4.4 Prepare a final validation report summarizing the results, including any deviations from the acceptance criteria.
5. Revalidation:
5.1 Revalidate the process if there are significant changes to the equipment, raw materials, or process parameters.
5.2 Periodically revalidate the process to ensure consistent product quality and compliance with regulatory standards.
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: Blending Process Record
| Date | Time | Operator Initials | Blending Duration | Remarks |
|---|---|---|---|---|
| DD/MM/YYYY | HH:MM | Operator Name | Duration in minutes | Process completed as per SOP |
Template 2: Batch Manufacturing Record
| Batch No. | Start Date | End Date | Blending Equipment | Operator Initials | Supervisor Signature |
|---|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | DD/MM/YYYY | Equipment Name | Operator Name | Supervisor Name |
Template 3: Equipment Calibration Log
| Equipment ID | Calibration Date | Next Calibration Due | Calibration Result | Calibrated By |
|---|---|---|---|---|
| Equipment Number | DD/MM/YYYY | DD/MM/YYYY | Pass/Fail | Technician Name |
Template 4: Process Validation Report
| Report ID | Batch No. | Validation Date | Validation Results | Verified By |
|---|---|---|---|---|
| Report Number | Batch Number | DD/MM/YYYY | Pass/Fail | QA 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 |