critical process parameters are followed and documented.
Quality Assurance (QA): Ensures that the compression process is validated in compliance with this SOP and regulatory requirements. QA is also responsible for reviewing and approving all validation documentation and reports.
Production Supervisors: Oversee the compression process and ensure that it is conducted according to the approved protocol, with operators following all required procedures.
Validation Team: Develops the tablet compression process validation protocol, executes the validation runs, and analyzes the results.
Maintenance Personnel: Ensures that the tablet compression equipment is properly calibrated, maintained, and functioning before and during the validation process.

4) Procedure

The following steps should be followed for the validation of the tablet compression process:

1. Preparation for Validation:
1.1 Review batch records to identify critical process parameters (CPPs) for the tablet compression process, such as tablet weight, hardness, and friability.
1.2 Develop a process validation protocol, including objectives, scope, equipment, and personnel involved in the validation process.
1.3 Ensure that all tablet compression equipment, such as rotary tablet presses and single-station presses, 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 tablet formulation and the specific tablet compression equipment used.
2.2 Defining Acceptance Criteria: Establish acceptance criteria for critical parameters such as tablet weight uniformity, hardness, friability, disintegration, and dissolution rate. The criteria should also include parameters such as compression force and speed.
2.3 Risk Assessment: Perform a risk assessment to identify critical quality attributes (CQAs) and corresponding critical process parameters (CPPs). This helps identify potential risks to tablet quality and establish mitigation strategies.

3. Execution of Validation:
3.1 Tablet Feeding: Validate the feeding process to ensure the correct amount of powder is consistently fed into the tablet press, ensuring uniformity in tablet weight.
3.2 Compression Force: Validate the compression force applied to the powder mixture. Ensure that the applied force produces tablets with the correct hardness while avoiding over-compression or under-compression.
3.3 Tablet Ejection: Ensure that the tablet ejection process does not cause damage to the tablets, such as chipping or cracking.
3.4 Tablet Hardness and Weight: Validate the tablet hardness and weight to ensure they meet the predefined specifications. Perform sampling at various time intervals to assess consistency.
3.5 Tablet Friability: Validate the friability of the tablets to ensure they are not overly brittle or prone to breakage.
3.6 Tablet Disintegration: Validate the disintegration time of the tablets to ensure they meet the specified disintegration criteria.
3.7 Tablet Dissolution: Conduct dissolution testing to ensure that the tablets release the active pharmaceutical ingredient (API) within the required time frame and that the release rate is consistent with the product 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 of the collected data to assess process consistency and capability. The analysis should confirm that the process is capable of producing tablets that meet all quality specifications.
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 compression process if there are significant changes to the formulation, equipment, or critical process parameters.
5.2 Periodically conduct revalidation to ensure continued compliance with regulatory requirements and confirm that the compression process remains capable of producing tablets that meet 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: Compression Process Record

Date	Time	Operator Initials	Compression Force	Tablet Weight
DD/MM/YYYY	HH:MM	Operator Name	Force in kN	Weight in mg

Template 2: Tablet Hardness Record

Batch No.	Tablet Hardness	Test Date	Operator Initials
Batch Number	Hardness in N	DD/MM/YYYY	Operator Name

Template 3: Tablet Disintegration Test Record

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

Template 4: Tablet Friability Record

Batch No.	Test Date	Friability (%)	Operator Initials
Batch Number	DD/MM/YYYY	Friability in %	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