Standard Operating Procedure for Ensuring Compliance with FDA Guidelines

Department	Tablet
SOP No.	SOP/TAB/209/2025
Supersedes	SOP/TAB/209/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

This SOP outlines the procedure for ensuring compliance with the FDA guidelines in tablet manufacturing. It ensures that all tablet production activities adhere to FDA regulations, including Good Manufacturing Practices (GMP), to ensure product safety, efficacy, and quality.

2. Scope

This SOP applies to all tablet manufacturing activities within the department, including raw material procurement, manufacturing processes, testing, packaging, and documentation, ensuring all activities comply with FDA guidelines.

3. Responsibilities

• Quality Assurance (QA) Manager: Responsible for overseeing compliance with FDA guidelines and ensuring that all tablet production processes meet regulatory requirements.
• Production Team: Responsible for adhering to FDA-compliant manufacturing procedures and reporting deviations to the QA team.
• Regulatory Affairs Team: Ensures that all manufacturing practices are in line with current FDA regulations and guidelines.
• Quality Control (QC) Team: Ensures that all quality control processes, including testing and inspections, comply with FDA standards.

4. Accountability

The QA Manager is accountable for ensuring that the tablet manufacturing process complies with FDA guidelines. All team members involved in production, testing, and regulatory affairs are responsible for adhering to these standards.

5. Procedure

5.1 FDA Guidelines Awareness and Training

1. Ensure that all personnel involved in tablet manufacturing are trained on FDA guidelines, including GMP, safety regulations, and regulatory requirements (Annexure-1).
2. Conduct regular training sessions and refresher courses to ensure employees remain updated on FDA regulations and guidelines.
3. Maintain training records and document the completion of training for all employees (Annexure-2).

5.2 Adherence to GMP Standards

1. Ensure that all manufacturing processes, including raw material handling, production, and packaging, follow FDA-approved GMP guidelines.
2. Verify that equipment used in manufacturing is properly calibrated and maintained according to FDA standards.
3. Ensure that facilities and environments are designed and maintained to meet FDA cleanliness and safety standards.
4. Conduct regular audits and inspections of the manufacturing processes to confirm adherence to GMP (Annexure-3).

5.3 Documentation and Record Keeping

1. Ensure that all records related to manufacturing, testing, and distribution are properly documented and maintained to meet FDA compliance standards.
2. Ensure that batch records, production logs, test results, and quality control records are accurately filled out and stored for a minimum of 5 years, as per FDA guidelines (Annexure-4).
3. Document any deviations from FDA guidelines or GMP standards and initiate corrective and preventive actions (CAPA) when necessary (Annexure-5).

5.4 Regulatory Compliance Inspections and Audits

1. Prepare for FDA inspections by ensuring that all documentation, procedures, and records are complete and compliant with current FDA regulations.
2. Conduct internal audits to ensure ongoing compliance with FDA guidelines, documenting any findings and corrective actions taken (Annexure-6).
3. Ensure that the Regulatory Affairs Team coordinates with the FDA during inspections, providing any requested documentation and responding to inquiries in a timely manner.

5.5 FDA Reporting and Communication

1. Ensure that any issues or deviations related to FDA compliance are reported immediately to the QA Manager and Regulatory Affairs Team.
2. Report any significant findings from FDA inspections, internal audits, or external audits to senior management, as well as any actions taken to resolve them.
3. Maintain a communication log detailing all correspondence with the FDA regarding compliance and corrective actions (Annexure-7).

5.6 Corrective and Preventive Actions (CAPA)

1. Implement CAPA for any non-compliance issues identified during audits or FDA inspections.
2. Document all CAPA activities, including root cause analysis, corrective actions taken, and effectiveness of the actions (Annexure-8).
3. Monitor the effectiveness of CAPA to prevent recurrence of non-compliance issues.

5.7 Continuous Improvement

1. Review FDA guidelines regularly to ensure that the tablet manufacturing process continues to comply with any new or updated regulations.
2. Implement a system for continuous improvement, incorporating feedback from audits, inspections, and employee suggestions to enhance compliance with FDA standards.

6. Abbreviations

• SOP: Standard Operating Procedure
• FDA: Food and Drug Administration
• GMP: Good Manufacturing Practice
• CAPA: Corrective and Preventive Action
• QC: Quality Control
• QA: Quality Assurance
• IPQC: In-Process Quality Control

7. Documents

1. FDA Compliance Training Records (Annexure-1)
2. FDA Compliance Training Log (Annexure-2)
3. Internal Audit Report (Annexure-3)
4. Batch Records and Production Logs (Annexure-4)
5. Deviation and CAPA Log (Annexure-5)
6. FDA Inspection and Communication Log (Annexure-6)
7. CAPA Records (Annexure-7)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• FDA Guidance for Industry – Current Good Manufacturing Practice
• ISO 9001 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: FDA Compliance Training Records

Employee Name	Training Date	Topic	Trainer
John Doe	01/02/2026	FDA GMP Regulations	Jane Smith

Annexure-2: FDA Compliance Training Log

Employee Name	Training Date	Certification Status
John Doe	01/02/2026	Certified

Annexure-3: Internal Audit Report

Audit Date	Auditor Name	Findings	Corrective Actions
01/03/2026	Jane Smith	No compliance with GMP standards	Implemented corrective measures

Annexure-4: Batch Records and Production Logs

Batch Number	Production Date	Product Name	Batch Size
Batch-12345	01/03/2026	Tablet A	5000 units

Annexure-5: Deviation and CAPA Log

Deviation ID	Description	Corrective Action	Action Taken By	Completion Date
DEV-001	Non-compliance with cleaning procedure	Reviewed and updated cleaning protocol	QA Manager	02/03/2026

Annexure-6: FDA Inspection and Communication Log

Inspection Date	Inspector Name	Inspection Findings	Action Required
15/02/2026	John Inspector	Minor discrepancies in labeling	Immediate corrective actions implemented

Annexure-7: CAPA Records

CAPA ID	Action	Responsible Person	Completion Date
CAPA-001	Updated training procedure	QA Head	03/03/2026

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 compliance process	Clarified regulatory requirements	QA Head