Standard Operating Procedure for Compliance with cGMP Guidelines in Tablet Production

Department	Tablet
SOP No.	SOP/TAB/179/2025
Supersedes	SOP/TAB/179/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the procedures for ensuring compliance with current Good Manufacturing Practice (cGMP) guidelines in tablet production, ensuring the production of safe, effective, and high-quality tablets.

2. Scope

This SOP applies to all aspects of tablet production, including raw material handling, formulation, tablet compression, coating, packaging, and final product inspection, ensuring that all activities meet cGMP standards.

3. Responsibilities

• Quality Assurance (QA): Responsible for overseeing compliance with cGMP guidelines, performing audits, and reviewing documents related to production processes.
• Production Supervisors: Ensure that all production activities follow established cGMP guidelines and SOPs, and that employees are properly trained in cGMP procedures.
• Maintenance Team: Responsible for ensuring that equipment is properly calibrated, maintained, and functioning according to cGMP standards.
• All Personnel: Follow all cGMP guidelines, report deviations or non-compliance, and ensure that personal hygiene and protective clothing requirements are met.

4. Accountability

The QA Manager is accountable for ensuring that the tablet production process adheres to cGMP guidelines and that all records and documentation are maintained in compliance with regulatory requirements.

5. Procedure

5.1 Training and Awareness

1. Ensure that all personnel involved in tablet production receive initial and periodic training on cGMP guidelines, company policies, and specific SOPs related to their roles.
2. Training should include cGMP requirements for raw material handling, equipment operation, sanitation practices, documentation, and safety protocols.
3. Keep records of all training sessions, including attendee names, training dates, and materials covered (Annexure-1).

5.2 Documentation and Record Keeping

1. Ensure that all production activities are documented, including batch records, cleaning logs, calibration logs, and any other records required by cGMP.
2. Ensure that records are accurate, legible, and complete, and that they are retained for the required period as per regulatory guidelines (Annexure-2).
3. Review and approve documents as necessary to ensure compliance with cGMP requirements before use in production.

5.3 Raw Material Control

1. Verify that all raw materials used in tablet production are approved for use, stored, and handled in compliance with cGMP guidelines.
2. Ensure that raw materials are received from approved vendors, and that Certificates of Analysis (CoA) are reviewed for each batch (Annexure-3).
3. Maintain a system for tracking raw materials from receipt through production to final product release.

5.4 Equipment and Facility Control

1. Ensure that all equipment used in tablet production is properly calibrated, maintained, and cleaned according to the required cGMP standards.
2. Monitor environmental conditions in production areas, including temperature, humidity, and cleanliness, to meet cGMP specifications.
3. Maintain and review records of equipment calibration and maintenance (Annexure-4).

5.5 In-Process Controls

1. Implement in-process controls to monitor key production parameters such as weight variation, tablet hardness, dissolution, and coating thickness during tablet manufacturing.
2. Use statistical process control methods to track variations and ensure that all in-process parameters remain within defined limits.
3. Document all in-process control data and take corrective actions as necessary to ensure the product meets specifications (Annexure-5).

5.6 Final Product Testing

1. Ensure that all final tablet products undergo testing for quality attributes, including but not limited to weight uniformity, hardness, dissolution, and friability, in compliance with cGMP standards.
2. Review and approve all testing results before release, ensuring that they meet the required specifications.
3. Document all final product test results and release forms (Annexure-6).

5.7 Sanitation and Hygiene

1. Implement strict sanitation procedures for the tablet production area, including regular cleaning and disinfecting of equipment and surfaces to prevent contamination.
2. Ensure that all personnel adhere to hygiene protocols, including wearing appropriate personal protective equipment (PPE), following handwashing protocols, and using cleanroom garments as required.
3. Maintain records of cleaning and sanitization activities (Annexure-7).

5.8 Corrective and Preventive Actions (CAPA)

1. Establish a CAPA process to investigate any deviations from cGMP guidelines or non-compliance issues that arise during tablet production.
2. Implement corrective actions to address root causes and preventive actions to avoid recurrence of issues.
3. Document all CAPA activities and monitor the effectiveness of the implemented actions (Annexure-8).

5.9 Internal Audits

1. Conduct regular internal audits to ensure ongoing compliance with cGMP guidelines. Audits should cover all areas of tablet production, including raw material handling, equipment calibration, in-process controls, and documentation.
2. Audit findings should be documented and corrective actions should be taken for any non-conformities.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• CAPA: Corrective and Preventive Action

7. Documents

1. Training Records (Annexure-1)
2. Production Records (Annexure-2)
3. Certificate of Analysis (CoA) Records (Annexure-3)
4. Equipment Maintenance and Calibration Logs (Annexure-4)
5. In-Process Control Data (Annexure-5)
6. Final Product Testing Records (Annexure-6)
7. Cleaning and Sanitation Records (Annexure-7)
8. CAPA Records (Annexure-8)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 9001 – Quality Management Systems
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Training Records

Employee Name	Training Date	Training Topic	Trainer Name	Score
John Doe	01/01/2026	cGMP Compliance	Jane Smith	90%

Annexure-2: Production Records

Batch Number	Production Date	Material Used	Quantity Produced	Signature
Batch-12345	01/01/2026	Material A	5000 Tablets	John Doe

Annexure-3: Certificate of Analysis (CoA) Records

Raw Material	CoA Number	Testing Date	Test Results
Excipient A	CoA-123	01/01/2026	Pass

Annexure-4: Equipment Maintenance and Calibration Logs

Equipment ID	Calibration Date	Next Calibration Date	Maintenance Performed
Tablet Press-001	01/01/2026	01/01/2027	Recalibrated and serviced

Annexure-5: In-Process Control Data

Batch Number	Test Parameter	Specification	Measured Value	Corrective Action
Batch-12345	Tablet Hardness	15-25 N	20 N	None

Annexure-6: Final Product Testing Records

Batch Number	Test Parameter	Specification	Test Result	Release Status
Batch-12345	Weight Uniformity	±5%	Pass	Released

Annexure-7: Cleaning and Sanitation Records

Area Cleaned	Cleaning Date	Cleaning Personnel	Cleaning Agent Used
Compression Area	01/01/2026	Jane Smith	Disinfectant A

Annexure-8: CAPA Records

CAPA ID	Issue Description	Corrective Action	Preventive Action	Completion Date
CAPA-001	Deviation in tablet hardness	Adjusted compression force	Reviewed process parameters	01/02/2026

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated documentation and CAPA procedures	Improved clarity and compliance measures	QA Head