approved protocol and procedures.
Validation Team: Responsible for creating the validation protocol, executing the validation runs, and analyzing the results.
Maintenance Personnel: Ensures that all equipment used in the manufacturing process is properly calibrated and maintained.

4) Procedure

The following steps should be followed for the process validation of sustained-release capsule manufacturing:

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

2. Validation Protocol:
2.1 Protocol Design: The validation protocol should be based on the formulation of the sustained-release capsules and the specific manufacturing process.
2.2 Defining Acceptance Criteria: Establish acceptance criteria for critical parameters such as capsule weight, content uniformity, release rate, and coating integrity.
2.3 Risk Assessment: Conduct a risk assessment to identify critical quality attributes (CQAs) and corresponding critical process parameters (CPPs), ensuring that potential risks to product quality are identified and mitigated.

3. Execution of Validation:
3.1 Mixing: Validate the mixing process to ensure the uniform distribution of active ingredients and excipients. Control the mixing time, speed, and temperature to achieve homogeneity.
3.2 Granulation (if applicable): Validate the granulation process by ensuring the proper size and uniformity of granules for sustained-release formulations.
3.3 Capsule Filling: Validate the capsule filling process, ensuring that the correct weight of the active ingredient and excipients are filled into each capsule.
3.4 Coating: If applicable, validate the coating process to ensure the proper coating thickness and uniformity, which is essential for controlling the drug release rate.
3.5 Release Testing: Perform in vitro dissolution testing to validate the sustained-release profile. Ensure that the capsules release the active ingredient over the intended time period in compliance with the drug release specifications.

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 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 Conduct periodic revalidation 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: Capsule Filling Record

Batch No.	Filling Date	Capsule Weight	Operator Initials	Supervisor Signature
Batch Number	DD/MM/YYYY	Weight in mg	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