SOP for Equipment Qualification in Ointment Manufacturing – V 2.0

Procedure for Equipment Qualification in Ointment Manufacturing

Department	Quality Assurance (QA)/Validation/Engineering/Production
SOP No.	SOP/Ointment/131
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 the process for equipment qualification in ointment manufacturing. This ensures that all equipment used in production meets predefined operational, performance, and compliance requirements before use.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Validation, Engineering, and Production departments responsible for the qualification of new, modified, or relocated equipment in ointment manufacturing.

3. Responsibilities

QA Officer: Ensures compliance with equipment qualification protocols.
Validation Team: Develops qualification protocols and executes validation studies.
Engineering Team: Supports installation and calibration of equipment.
Production Supervisor: Ensures adherence to equipment qualification requirements.
QA Manager: Approves final qualification reports and maintains documentation.

4. Accountability

The QA and Validation Managers are accountable for ensuring that all equipment used in ointment manufacturing undergoes proper qualification as per GMP, FDA, ICH, and WHO guidelines.

5. Procedure

5.1 Phases of Equipment Qualification

Equipment qualification follows four key phases:

Design Qualification (DQ): Verification that the equipment design meets process requirements.
Installation Qualification (IQ): Ensures the equipment is installed according to manufacturer specifications.
Operational Qualification (OQ): Confirms the equipment functions

as intended under operating conditions.

Performance Qualification (PQ): Validates that the equipment consistently performs under real production conditions.

5.2 Design Qualification (DQ)

Ensure equipment design meets GMP and process requirements.
Review manufacturer specifications and functional requirements.
Document risk assessments and compliance evaluations.
Approve DQ report before proceeding to installation.

5.3 Installation Qualification (IQ)

Verify that the equipment is installed in accordance with manufacturer guidelines.
Ensure proper electrical, mechanical, and environmental setup.
Confirm calibration and alignment with other production systems.
Document all installation parameters in the IQ report.

5.4 Operational Qualification (OQ)

Conduct test runs to confirm equipment operates within set parameters.
Verify process variables, including:
- Temperature control
- Mixing speeds
- Homogenization efficiency
- Heating and cooling rates
Document operational test results and corrective actions.
Obtain approval for the OQ report before proceeding to performance qualification.

5.5 Performance Qualification (PQ)

Perform test production batches using qualified equipment.
Ensure consistency in:
- Batch uniformity
- Product viscosity and spreadability
- Filling precision and sealing integrity
Document performance results and approve final qualification.

5.6 Requalification and Maintenance

Conduct periodic requalification based on equipment usage and performance trends.
Initiate requalification after major repairs or modifications.
Ensure proper documentation of maintenance and calibration activities.

5.7 Documentation and Review

Maintain all qualification reports in the Equipment Qualification Log.
QA must review and approve all qualification records.
Ensure data is available for regulatory audits.

6. Abbreviations

GMP – Good Manufacturing Practices
QA – Quality Assurance
IQ – Installation Qualification
OQ – Operational Qualification
PQ – Performance Qualification
DQ – Design Qualification

7. Documents

Equipment Qualification Protocol (Annexure-1)
Equipment Qualification Log (Annexure-2)

8. References

ICH Q7 – Good Manufacturing Practice Guide
WHO Guidelines for Equipment Qualification
US FDA Guidance on Equipment Validation

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Equipment Qualification Protocol

Equipment Type	Qualification Phase	Test Parameter	Acceptance Criteria
Mixing Tank	OQ	Agitation Speed	± 5% of set value
Filling Machine	PQ	Fill Volume Accuracy	± 1% of target

Annexure-2: Equipment Qualification Log

Date	Equipment ID	Qualification Phase	Test Performed	Result	Reviewed By
01/02/2025	MIX-1001	IQ	Installation Verification	Pass	QA Manager
02/02/2025	FILL-2002	PQ	Batch Performance	Pass	QA Manager

12. Revision History:

Revision Date	Revision No.	Details of Revision	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated SOP Format	Standardization of Document	QA Head