PERFORMANCE QUALIFICATION

Document No: QST-PQ-001

Version: 1.0

Status: COMPLETED ✅

PQ Period: 23 March – 01 April 2026

Prepared by: Rajesh Kumar | QA Manager

Approved by: Amit Patel | Production Supervisor

Facility: Stratogene Pharma Pvt. Ltd.

Section 1: Purpose

This PQ protocol confirms QsutraIPQA v1.0 performs consistently and reliably under actual production conditions over a defined qualification period.

Section 2: PQ Scope

PQ was conducted over 10 production days (23 Mar – 01 Apr 2026) covering:

15 tablet batches across 3 products
8 capsule batches across 2 products
5 liquid batches across 2 products
28 batches total — 420 IPQA checks
3 deviations raised and closed
2 CAPAs completed

Section 3: Performance Metrics

Metric	Target	Actual	Status
System availability	≥ 99.5%	99.9%	✅
eBR creation success	100%	100%	✅
E-signature success	100%	100%	✅
Check entry response	< 2 sec	0.4 sec	✅
Audit trail completeness	100%	100%	✅
SHA-256 verification	100%	100%	✅
Deviation workflow	100%	100%	✅

Section 4: Batch Record Review

28 batch records were reviewed for completeness and accuracy. All 28 records:

✅ Complete — no missing fields
✅ Accurate — values match source data
✅ Traceable — full operator attribution
✅ Timestamped — NTP-verified UTC
✅ Integrity — SHA-256 hash verified

Section 5: PQ Conclusion

QsutraIPQA v1.0 has performed consistently and reliably during the qualification period. All performance targets were met or exceeded. The system is declared VALIDATED and approved for routine production use.

PQ Status: ✅ COMPLETED — 01 April 2026

PQ Executed by

Name: Rajesh Kumar

Title: QA Manager

Date: 01 Apr 2026

PQ Approved by

Name: Amit Patel

Title: Production Supervisor

Date: 01 Apr 2026