Standard Operating Procedure for Validating Oral Film and Strip Manufacturing Process
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for the process validation of oral films and strips. This SOP ensures that the manufacturing process consistently produces oral films and strips that meet the required quality specifications. It provides a structured approach to validate the critical steps in the manufacturing process, ensuring that the final product is safe, effective, and compliant with regulatory standards.
2) Scope
This SOP is applicable to the production of all oral films and strips within the facility, including both medicated and non-medicated films. The SOP covers process validation activities for both new formulations and those undergoing significant process changes. This SOP is intended for use by quality assurance (QA), production teams, and technical personnel involved in the manufacturing, validation, and quality control of oral films and strips.
3) Responsibilities
Operators: Responsible for performing the process validation tasks according to the approved protocol.
Quality Assurance (QA): Ensures that the process validation is carried out in accordance with this SOP and meets regulatory requirements. QA verifies all documentation and approves the validation reports.
Production
Validation Team: Responsible for creating the validation protocol, executing the validation runs, and analyzing the results.
Maintenance Personnel: Ensures that the equipment used in the manufacturing process is properly calibrated and maintained.
4) Procedure
The following steps should be followed for the process validation of oral film and strip manufacturing:
1. Preparation for Validation:
1.1 Review the batch records to identify critical process parameters (CPPs) for each step in the oral film and strip manufacturing process.
1.2 Prepare the process validation protocol, which should include objectives, scope, process flow, equipment used, and personnel involved.
1.3 Ensure that all equipment, such as mixing vessels, film casting machines, and drying equipment, is calibrated and operational before initiating the validation process.
2. Validation Protocol:
2.1 Protocol Design: The validation protocol should be designed based on the oral film or strip formulation and the manufacturing process flow.
2.2 Defining Acceptance Criteria: Establish acceptance criteria for critical parameters such as film uniformity, disintegration time, thickness, mechanical strength, and active ingredient content.
2.3 Risk Assessment: Perform a risk assessment to identify critical quality attributes (CQAs) and corresponding critical process parameters (CPPs), ensuring that potential risks to product quality are mitigated.
3. Execution of Validation:
3.1 Mixing: Ensure that the active ingredients, excipients, and solvents are uniformly mixed by controlling mixing time, speed, and temperature.
3.2 Film Formation: Validate the film formation process by controlling casting, drying time, and temperature to ensure uniformity and consistency of the final product.
3.3 Coating: If applicable, validate the coating process to ensure uniformity and proper adhesion of any coating applied to the oral films.
3.4 Thickness and Weight Testing: Perform tests to ensure that the thickness and weight of the oral films or strips are consistent with the predetermined specifications.
3.5 Disintegration and Release Testing: Validate the disintegration time of the oral films and strips, ensuring they meet the predefined release profile and therapeutic requirements.
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 that 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 ensure 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 significant changes to the formulation, raw materials, or critical process parameters.
5.2 Conduct periodic revalidation to ensure consistent product quality and regulatory compliance over time.
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: Film Casting Record
| Batch No. | Casting Date | Coating Type | Operator Initials | Supervisor Signature |
|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Coating Type | Operator Name | Supervisor Name |
Template 3: Thickness and Weight Testing Record
| Batch No. | Thickness (mm) | Weight (mg) | Test Date | Operator Initials |
|---|---|---|---|---|
| Batch Number | Measured Thickness | Measured Weight | DD/MM/YYYY | Operator 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 |