are met and documented.
Quality Assurance (QA): Ensures that the encapsulation process validation is conducted in compliance with this SOP and meets all regulatory requirements. QA is also responsible for reviewing and approving all validation documentation and reports.
Production Supervisors: Oversee the encapsulation process and ensure that operators follow all required procedures and that the process is conducted according to the approved protocol.
Validation Team: Responsible for designing the encapsulation process validation protocol, executing validation runs, and analyzing results.
Maintenance Personnel: Ensures that encapsulation equipment, such as capsule filling machines and sealing equipment, is calibrated, maintained, and functioning during the validation process.

4) Procedure

The following steps should be followed for the validation of the encapsulation process for capsules:

1. Preparation for Validation:
1.1 Review batch records and product specifications to identify critical process parameters (CPPs) for the encapsulation process, such as capsule weight, fill weight, and capsule integrity.
1.2 Develop a process validation protocol that includes the objectives, scope, equipment, process flow, and personnel involved in the validation process.
1.3 Ensure that all encapsulation equipment, including capsule filling machines, capsule-sealing machines, and capsule inspection stations, are calibrated and operational before initiating the validation process.

2. Validation Protocol:
2.1 Protocol Design: The validation protocol should be designed based on the formulation of the capsules and the specific encapsulation equipment used.
2.2 Defining Acceptance Criteria: Establish acceptance criteria for critical parameters such as capsule fill weight, capsule uniformity, hardness, seal integrity, and visual appearance.
2.3 Risk Assessment: Conduct a risk assessment to identify critical quality attributes (CQAs) and corresponding critical process parameters (CPPs). This helps ensure that all potential risks to product quality are identified and controlled.

3. Execution of Validation:
3.1 Encapsulation Machine Setup: Validate the setup of the encapsulation machine, ensuring that it is properly adjusted to handle the specified fill material, capsule size, and operating conditions.
3.2 Capsule Filling: Validate the filling process to ensure that the correct amount of fill material is delivered into each capsule. This includes verifying the fill weight for each capsule to ensure consistency across the batch.
3.3 Capsule Sealing: Validate the sealing process to ensure that capsules are properly sealed and that there is no leakage. This includes checking for proper capsule closure and assessing seal integrity.
3.4 Capsule Weight and Fill Uniformity: Validate the uniformity of the capsule weight and content fill. This involves checking both individual capsule weights and fill distribution to ensure that they meet the predefined specifications.
3.5 Capsule Integrity: Validate capsule integrity by assessing the capsules for any defects such as cracks, leakage, or improper sealing. Inspect the capsules visually and perform mechanical tests to ensure they are intact.
3.6 Capsule Inspection: Perform routine visual inspections to detect any defects, such as broken or damaged capsules, and to ensure the final product meets all appearance specifications.
3.7 Moisture Content: Check the moisture content of the capsules to ensure that they are within the specified limits, as excessive moisture could affect the stability and quality of the capsules.

4. Documentation and Reporting:
4.1 Record all data during the validation process, including batch records, equipment logs, process parameters, and inspection results.
4.2 Ensure that all forms, reports, and certificates are completed and signed by the responsible personnel.
4.3 Perform statistical analysis of the collected data to assess process consistency and capability. This analysis should confirm that the encapsulation process is capable of producing capsules that meet the acceptance criteria.
4.4 Prepare a final validation report summarizing the results of the validation, including any deviations, corrective actions, and conclusions regarding the encapsulation process.

5. Revalidation:
5.1 Revalidate the encapsulation process if there are significant changes to the formulation, equipment, or critical process parameters.
5.2 Conduct periodic revalidation to ensure continued compliance with regulatory requirements and to confirm that the encapsulation process remains capable of producing capsules that meet all quality specifications.

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: Encapsulation Process Record

Date	Time	Operator Initials	Fill Weight	Capsule Integrity
DD/MM/YYYY	HH:MM	Operator Name	Weight in mg	Pass/Fail

Template 2: Capsule Inspection Record

Batch No.	Inspection Date	Visual Defects	Operator Initials
Batch Number	DD/MM/YYYY	Pass/Fail	Operator Name

Template 3: Capsule Moisture Content Record

Batch No.	Moisture Content	Test Date	Operator Initials
Batch Number	Moisture in %	DD/MM/YYYY	Operator Name

Template 4: Statistical Analysis Data

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