Procedure for Maintaining Records of Utility Validation

Department	Quality Assurance (QA)/Validation/Engineering
SOP No.	SOP/Ointment/148
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define a structured process for maintaining records related to utility validation. Proper documentation ensures compliance with regulatory standards, facilitates audits, and allows continuous monitoring of utilities such as HVAC, water systems, compressed air, and electrical supply.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Validation, and Engineering departments responsible for maintaining and managing records of utility validation.

3. Responsibilities

• QA Officer: Ensures compliance with documentation protocols.
• Validation Team: Collects and archives validation records.
• Engineering Team: Ensures accurate logging of utility performance data.
• QA Manager: Reviews and approves validation records.

4. Accountability

The QA and Engineering Managers are accountable for ensuring that all records related to utility validation are maintained as per GMP, FDA, ICH, and WHO guidelines.

5. Procedure

5.1 Types of Records to be Maintained

The following records must be maintained for utility validation:

• Validation Protocols: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Utility Performance Logs: Daily, weekly, and monthly performance records of utilities.
• Trend Analysis Reports: Periodic assessments of utility performance over time.
• Deviation and CAPA Reports: Documentation of any deviations and associated corrective actions.
• Calibration Records: Logs of calibration and maintenance of monitoring instruments.

5.2 Documentation Format and Storage

• All records should be maintained in both physical and digital formats.
• Each document must have:
  • Title and document number
  • Issue and revision date
  • Authorized signatures
• Storage locations must be secure and accessible to authorized personnel only.

5.3 Data Entry and Record Keeping

• Data must be recorded in real-time.
• Entries must be legible, signed, and dated.
• Corrections should follow ALCOA+ principles:
  • Attributable
  • Legible
  • Contemporaneous
  • Original
  • Accurate

5.4 Retention and Archival of Records

• Utility validation records should be retained for a minimum of five years or as per regulatory requirements.
• Archived records should be:
  • Indexed properly for easy retrieval.
  • Protected from environmental damage (e.g., moisture, heat).
• Digital records should have backup copies stored in secure locations.

5.5 Review and Approval Process

• All records should be reviewed by the QA Manager.
• Deviations and corrective actions should be assessed and approved before final documentation.
• Periodic audits should be conducted to verify record integrity.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• HVAC – Heating, Ventilation, and Air Conditioning
• CAPA – Corrective and Preventive Actions
• OOS – Out of Specification

7. Documents

• Utility Validation Log (Annexure-1)
• Document Control Register (Annexure-2)

8. References

• ICH Q7 – Good Manufacturing Practice Guide
• WHO Guidelines for Utility Validation
• US FDA Guidance on Documentation Practices

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Utility Validation Log

Date	Utility Type	Parameter Monitored	Recorded Value	Acceptance Criteria	Reviewed By
01/02/2025	HVAC	Room Temperature	22°C	20-24°C	QA Manager
02/02/2025	Water System	Conductivity	1.2 µS/cm	≤ 1.3 µS/cm	QA Manager

Annexure-2: Document Control Register

Document ID	Document Name	Version	Issue Date	Retention Period	Reviewed By
UV-001	HVAC Validation Report	2.0	01/01/2025	5 Years	QA Manager
UV-002	Compressed Air Validation Log	2.0	02/01/2025	5 Years	QA Manager