and documented.
Quality Assurance (QA): Ensures that the coating process validation is performed in compliance with this SOP and meets regulatory requirements. QA also reviews and approves all validation reports and documentation.
Production Supervisors: Oversee the coating process, ensuring it is performed according to the approved protocol and that operators follow all required procedures.
Validation Team: Responsible for developing the validation protocol, executing the validation runs, and analyzing the results.
Maintenance Personnel: Ensures that the coating equipment is properly calibrated, maintained, and functioning during the validation process.

4) Procedure

The following steps should be followed for the validation of the coating process for tablets:

1. Preparation for Validation:
1.1 Review batch records and product specifications to identify critical process parameters (CPPs) for the coating process, such as coating weight, coating uniformity, and drying time.
1.2 Develop a process validation protocol that includes the objectives, scope, equipment, and process flow, along with the personnel involved in the validation process.
1.3 Ensure that all coating equipment, such as pan coaters, fluidized bed coaters, and spray guns, are calibrated and operational before initiating the validation process.

2. Validation Protocol:
2.1 Protocol Design: The validation protocol should be based on the formulation of the tablets and the type of coating process used (e.g., film coating, sugar coating).
2.2 Defining Acceptance Criteria: Establish acceptance criteria for critical parameters such as coating weight, coating uniformity, drying time, tablet appearance, and dissolution rate. These criteria ensure that the coating process consistently meets the specified requirements.
2.3 Risk Assessment: Conduct a risk assessment to identify critical quality attributes (CQAs) and corresponding critical process parameters (CPPs) for the coating process. The goal is to ensure that any risks to product quality are identified and controlled.

3. Execution of Validation:
3.1 Coating Solution Preparation: Validate the preparation of the coating solution to ensure that it is uniformly mixed and that the correct concentration of coating materials (e.g., polymers, colorants, and plasticizers) is used.
3.2 Tablet Loading: Validate the loading of tablets into the coating pan to ensure that the correct number of tablets are loaded and that they are evenly distributed throughout the process.
3.3 Spraying: Validate the spraying process to ensure that the coating solution is uniformly applied to the tablets. This involves monitoring spray rate, spray pressure, and the distance between the spray nozzle and the tablets.
3.4 Drying: Validate the drying process to ensure that the tablets are dried to the required residual moisture content without over-drying or under-drying, which could affect the quality of the coating.
3.5 Coating Thickness: Validate the coating thickness by taking representative samples and measuring the thickness of the coating on individual tablets. The coating should be uniform and meet the predefined specifications.
3.6 Tablet Appearance: Inspect the tablets for any visual defects such as chipping, cracking, or incomplete coating. Tablets should have a smooth, uniform appearance.
3.7 Coating Uniformity: Validate coating uniformity by sampling tablets from different locations within the batch and testing for uniformity in weight and thickness of the coating.

4. Documentation and Reporting:
4.1 Record all data throughout the validation process, including batch records, equipment logs, process parameters, and sampling 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 consistency and capability. This analysis should confirm that the coating process is capable of producing tablets that meet all quality specifications.
4.4 Prepare a final validation report summarizing the results of the validation, including any deviations, corrective actions, and conclusions regarding the validity of the coating process.

5. Revalidation:
5.1 Revalidate the coating 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 coating process remains capable of producing tablets 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: Coating Process Record

Date	Time	Operator Initials	Spray Rate	Coating Solution Volume
DD/MM/YYYY	HH:MM	Operator Name	Rate in mL/min	Volume in mL

Template 2: Tablet Coating Thickness Record

Batch No.	Test Date	Tablet Location	Coating Thickness	Operator Initials
Batch Number	DD/MM/YYYY	Tablet Position	Thickness in mm	Operator Name

Template 3: Tablet Appearance and Inspection Record

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

Template 4: Tablet Disintegration Test Record

Batch No.	Test Date	Disintegration Time	Operator Initials
Batch Number	DD/MM/YYYY	Time in minutes	Operator Name

Template 5: Statistical Analysis Data

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