SOP for Performance Qualification (PQ) of Filling Machines – V 2.0

Procedure for Performance Qualification (PQ) of Filling Machines

Department	Quality Assurance (QA)/Validation/Engineering/Production
SOP No.	SOP/Ointment/134
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 conducting Performance Qualification (PQ) of filling machines used in ointment manufacturing. This ensures that the machines consistently operate within specified parameters and meet quality and regulatory requirements.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Validation, Engineering, and Production departments responsible for performing and documenting Performance Qualification (PQ) of filling machines.

3. Responsibilities

QA Officer: Ensures compliance with PQ protocols.
Validation Team: Develops and executes PQ protocols.
Engineering Team: Supports calibration and performance verification of filling machines.
Production Supervisor: Ensures adherence to qualification testing procedures.
QA Manager: Approves PQ reports and maintains documentation.

4. Accountability

The QA and Validation Managers are accountable for ensuring that Performance Qualification (PQ) is conducted as per GMP, FDA, ICH, and WHO guidelines.

5. Procedure

5.1 Preparation for Performance Qualification (PQ)

Ensure that Operational Qualification (OQ) has been successfully completed.
Review and approve the Performance Qualification Protocol.
Verify the availability of calibrated measuring instruments.
Assign trained personnel to conduct the PQ tests.
Ensure that machine settings align with

manufacturing specifications.

5.2 Execution of Performance Qualification (PQ)

5.2.1 Functional Testing

Verify startup and shutdown sequences of the filling machine.
Ensure that control panel indicators, alarms, and emergency stop functions operate correctly.
Confirm that conveyor, nozzles, and filling mechanisms function as intended.

5.2.2 Performance Testing

Conduct test runs using placebo or product batches.
Evaluate the following parameters:
- Filling accuracy and weight variation
- Speed and efficiency of the filling process
- Seal integrity and cap placement
- Container alignment and rejection rate
Document results for each test run.

5.2.3 Repeatability and Consistency Testing

Perform three consecutive successful test runs.
Verify that results remain within acceptable limits.
Identify and document any performance deviations.

5.3 Documentation and Approval

Record all PQ data in the Performance Qualification Log.
QA must review and approve PQ results before releasing the machine for production.
Maintain all records for regulatory audits.

6. Abbreviations

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

7. Documents

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

8. References

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

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Performance Qualification Protocol

Equipment Type	Test Parameter	Acceptance Criteria
Filling Machine	Filling Accuracy	± 1% of target weight
Filling Machine	Seal Integrity	No leakage, firm seal

Annexure-2: Performance Qualification Log

Date	Equipment ID	Test Performed	Result	Reviewed By
01/02/2025	FILL-1001	Filling Accuracy Test	Pass	QA Manager
02/02/2025	FILL-1002	Seal Integrity Test	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