Standard Operating Procedure for Ensuring Compliance with Regulatory Guidelines

Department	Tablet
SOP No.	SOP/TAB/198/2025
Supersedes	SOP/TAB/198/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To establish procedures for ensuring compliance with regulatory guidelines and ensuring that all manufacturing practices meet local and international standards, including FDA, ICH, and GMP regulations.

2. Scope

This SOP applies to all tablet manufacturing operations within the facility, including the review, implementation, and continuous monitoring of regulatory requirements that affect product quality and safety.

3. Responsibilities

• Quality Assurance (QA): Responsible for ensuring that the manufacturing processes, documentation, and products comply with applicable regulatory guidelines. QA is also responsible for conducting internal audits and monitoring compliance levels.
• Production Team: Responsible for following approved procedures and maintaining records as per regulatory requirements during the production process.
• Regulatory Affairs Team: Responsible for staying up to date with the latest regulatory guidelines and ensuring their effective integration into manufacturing practices.
• Quality Control (QC): Responsible for ensuring that quality control testing and documentation meet regulatory standards.

4. Accountability

The QA Manager is accountable for ensuring compliance with this SOP and regulatory guidelines across all departments. The Production Manager is accountable for implementing practices to comply with regulatory standards during the tablet manufacturing process.

5. Procedure

5.1 Regulatory Requirement Identification

1. Identify the applicable regulatory requirements that govern tablet manufacturing, such as FDA, ICH, and GMP guidelines, as well as any local or international standards that apply to the production of tablets.
2. Ensure that all necessary regulatory updates are incorporated into internal SOPs, batch records, and process documentation to reflect the most current guidelines.
3. Review and assess any new or revised guidelines issued by regulatory bodies and evaluate their impact on existing practices.

5.2 Integration of Regulatory Requirements into Manufacturing Practices

1. Incorporate regulatory requirements into the design, operation, and monitoring of tablet manufacturing processes, including raw material sourcing, production controls, and final product testing.
2. Ensure that all processes related to tablet manufacturing, including formulation, granulation, compression, coating, and packaging, comply with regulatory standards.
3. Ensure proper documentation practices are followed to meet regulatory requirements, including maintaining detailed batch records, quality control records, and stability testing reports.

5.3 Training and Awareness

1. Ensure that all personnel involved in tablet manufacturing are trained on the regulatory guidelines and their responsibilities in maintaining compliance.
2. Conduct periodic training sessions to update employees on any new or modified regulations, industry standards, or compliance procedures.
3. Ensure that training records are documented and retained in compliance with regulatory guidelines (Annexure-1).

5.4 Compliance Monitoring

1. Implement regular audits of tablet manufacturing processes, documentation, and records to assess compliance with regulatory requirements.
2. Monitor adherence to regulatory requirements during each stage of the production process, from raw material receipt to final product packaging.
3. Perform internal audits of manufacturing areas, equipment, and processes to ensure that they comply with GMP and other regulatory guidelines.
4. Document any deviations from regulatory guidelines and investigate the causes of non-compliance (Annexure-2).

5.5 Corrective and Preventive Actions (CAPA)

1. If any non-compliance or deviation from regulatory guidelines is identified during monitoring or audits, initiate corrective and preventive actions (CAPA) to resolve the issue and prevent recurrence.
2. Document all CAPA activities, including the identification of the issue, investigation, corrective action taken, and verification of the effectiveness of the action (Annexure-3).
3. Review CAPA records regularly to ensure that all corrective actions have been effectively implemented and that any issues identified are addressed comprehensively.

5.6 Compliance Documentation and Record Keeping

1. Maintain all relevant documentation and records to demonstrate compliance with regulatory guidelines. This includes batch records, quality control testing data, stability studies, and inspection reports (Annexure-4).
2. Ensure that all records are accurate, complete, and available for review during regulatory inspections and audits.
3. Ensure that all records are stored and retained for the required time period according to regulatory guidelines, typically five years or as per local regulations.

5.7 Regulatory Reporting

1. Ensure timely submission of required documentation and reports to regulatory authorities as per applicable regulations.
2. Submit product registration documents, regulatory filings, and post-market surveillance reports to the relevant authorities.
3. Maintain a log of regulatory submissions and approvals, ensuring that all required actions are documented and tracked (Annexure-5).

5.8 Periodic Review of Regulatory Compliance

1. Conduct periodic reviews of the manufacturing processes, SOPs, and records to ensure continued compliance with regulatory guidelines.
2. Implement any necessary changes or improvements to maintain compliance and ensure that all new or revised regulatory requirements are met.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• GMP: Good Manufacturing Practice
• CAPA: Corrective and Preventive Action
• FDA: Food and Drug Administration
• ICH: International Council for Harmonisation

7. Documents

1. Regulatory Guidelines Compliance Log (Annexure-1)
2. Deviation and Non-Compliance Report (Annexure-2)
3. CAPA Documentation (Annexure-3)
4. Compliance Documentation Log (Annexure-4)
5. Regulatory Reporting Log (Annexure-5)

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: Regulatory Guidelines Compliance Log

Guideline	Version	Effective Date	Compliance Status	Remarks
FDA 21 CFR Part 211	2025	01/01/2025	Compliant	All required actions completed

Annexure-2: Deviation and Non-Compliance Report

Deviation ID	Description	Corrective Action	Completion Date
DEV-001	Failure to follow batch record procedure	Re-trained production team	01/04/2026

Annexure-3: CAPA Documentation

Action ID	Action Description	Responsible Person	Completion Date
CAPA-001	Corrected non-compliance issue from last audit	Jane Smith	01/05/2026

Annexure-4: Compliance Documentation Log

Document	Version	Approval Date	Approved By
Batch Record	1.0	01/03/2026	QA Head

Annexure-5: Regulatory Reporting Log

Report	Submission Date	Authority	Status
Product Registration	01/01/2026	FDA	Submitted

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 monitoring process	Improved compliance checks	QA Head