CENTRAL COMMAND CENTREKarachi Manufacturing Plant • Batch Release Qualified Person (QP) / QA Director

Unified Pharmaceutical Enterprise Workstation

Consolidating manufacturing batch execution (eBMR), laboratory quality control (LIMS), deviations & CAPA (eQMS), regulatory market authorizations (RIMS), and simulated audit ledger into one coordinated system.

Facility Scope: Karachi Manufacturing Plant•WIP Valuation: PKR 639.92B•Risk Profile: ELEVATED (Score: 55.0)
100% CLIENT ENGINE • STATIC EXPORT SAFE • ZERO BACKEND
Active Manufacturing & Quality Exceptions Requiring Disposition5 Critical Dev • 8 Batches On Hold • 3 OOS Sample

Batch release invariant active: batches with open critical deviations or uninvestigated OOS samples cannot be released by Qualified Person until resolved.

Manufacturing
39
Active eBMR Batches
52 In Active Scope
QA Batch Holds
8
Batches Under Hold
QA Clearance Required
QC Laboratory
53
Samples in Testing
3 OOS Flagged
eQMS Quality
26
Open Deviations
5 Critical • 6 Major
Yield Performance
97.9%
Mean Facility Yield
Mass Balance Valid
QP Release
5
Batches Released
BX-2026-0891 Golden

Active eBMR Manufacturing Batch Pipeline

52 Batches
Batch NoFinished ProductCurrent StageYieldStatusDossier
BX-2026-0891Amoxicillin Trihydrate BP 500mgPackaging99.4%Released
BMR-2026-0892Syntamatic Metformin XR 1000mgCompression97.7%In Progress
BMR-2026-0893Ceftriaxone Sodium IV 1000mgCompression93.5%On Hold
BMR-2026-0894Paracetamol BP 500mgPackaging97.4%In Progress
BMR-2026-0895Omeprazole Pellets 20mgQC_Testing99.6%In Progress

Active Batch Hold & QA Disposition Queue

13 Pending
BMR-2026-0893Ceftriaxone Sodium IV 1000mgQA HOLD

Site: Karachi Manufacturing Plant • Lot Size: 100,000 vials • Valuation: PKR 3.24B

BMR-2026-0896Ibuprofen BP 400mgQA_Review

Site: Karachi Manufacturing Plant • Lot Size: 400,000 tablets • Valuation: PKR 9.24B

BMR-2026-0897Amoxicillin Trihydrate BP 500mgQA HOLD

Site: Karachi Manufacturing Plant • Lot Size: 250,000 capsules • Valuation: PKR 6.4B

BMR-2026-0899Ceftriaxone Sodium IV 1000mgQA HOLD

Site: Karachi Manufacturing Plant • Lot Size: 100,000 vials • Valuation: PKR 2.36B

BMR-2026-0904Syntamatic Metformin XR 1000mgQA HOLD

Site: Karachi Manufacturing Plant • Lot Size: 500,000 tablets • Valuation: PKR 17.24B

BMR-2026-0911Ceftriaxone Sodium IV 1000mgQA HOLD

Site: Karachi Manufacturing Plant • Lot Size: 100,000 vials • Valuation: PKR 2.7B

BMR-2026-0912Paracetamol BP 500mgQA_Review

Site: Karachi Manufacturing Plant • Lot Size: 1,000,000 tablets • Valuation: PKR 39.04B

BMR-2026-0913Omeprazole Pellets 20mgQA HOLD

Site: Karachi Manufacturing Plant • Lot Size: 300,000 capsules • Valuation: PKR 9.92B

BMR-2026-0920Ibuprofen BP 400mgQA_Review

Site: Karachi Manufacturing Plant • Lot Size: 400,000 tablets • Valuation: PKR 14.69B

BMR-2026-0927Amoxicillin Trihydrate BP 500mgQA HOLD

Site: Karachi Manufacturing Plant • Lot Size: 250,000 capsules • Valuation: PKR 9.05B

BMR-2026-0928Syntamatic Metformin XR 1000mgQA_Review

Site: Karachi Manufacturing Plant • Lot Size: 500,000 tablets • Valuation: PKR 14.22B

BMR-2026-0936Paracetamol BP 500mgQA_Review

Site: Karachi Manufacturing Plant • Lot Size: 1,000,000 tablets • Valuation: PKR 29.68B

BMR-2026-0939Amoxicillin Trihydrate BP 500mgQA HOLD

Site: Karachi Manufacturing Plant • Lot Size: 250,000 capsules • Valuation: PKR 10.44B

Laboratory Workload & Analytical Exceptions (LIMS)

160 Samples
QC-2026-0891-01(Batch: BX-2026-0891)Approved
Assay by HPLC (Amoxicillin) • Method: Finished Product
99.8% (Pass)
Spec: 95.0% – 105.0% of labeled claim
QC-2026-0891-02(Batch: BX-2026-0891)Approved
Dissolution Test (Apparatus 1, 100 RPM, 45 min) • Method: Finished Product
88.4% (Pass)
Spec: Q ≥ 80% dissolved in 45 min
QC-2026-0891-03(Batch: BX-2026-0891)Approved
Related Substances / Degradation Products • Method: Finished Product
0.28% Total (Pass)
Spec: Individual ≤ 1.0%, Total ≤ 3.0%
QC-2026-0894-02(Batch: BMR-2026-0899)Approved
Water Content by Karl Fischer • Method: Raw Material
3.2% (Pass)
Spec: ≤ 5.0% w/w
QC-2026-0895-03(Batch: BMR-2026-0901)In Testing
Hardness & Friability Test • Method: Finished Product
110 N / 0.12% (Pass)
Spec: Hardness ≥ 80 N, Friability < 0.8%

My Work & Assigned Approvals

13 Assigned
Dr. Ayesha Khan
QA Release Review: Batch BMR-2026-0893HIGH

Ceftriaxone Sodium IV 1000mg awaiting final QP disposition and Certificate of Analysis sign-off

QA Release Review: Batch BMR-2026-0896NORMAL

Ibuprofen BP 400mg awaiting final QP disposition and Certificate of Analysis sign-off

QA Release Review: Batch BMR-2026-0897HIGH

Amoxicillin Trihydrate BP 500mg awaiting final QP disposition and Certificate of Analysis sign-off

QA Release Review: Batch BMR-2026-0899HIGH

Ceftriaxone Sodium IV 1000mg awaiting final QP disposition and Certificate of Analysis sign-off

Quality Deviations & CAPA (eQMS)

26 Open
DEV-2026-0039Critical

Acid resistance failure during enteric capsule dissolution testing

Batch: BMR-2026-0893Investigator: Sana Iqbal
DEV-2026-0043Critical

Environmental particle count exceedance in Cleanroom ISO Class 7 corridor

Batch: BMR-2026-0897Investigator: Syed Ali Raza
DEV-2026-0044Major

Tablet friability excursion (>1.0%) on Rotary Press Suite B

Batch: BMR-2026-0904Investigator: Fatima Noor
DEV-2026-0045Minor

Packaging barcode verification camera intermittent scanning lag

Batch: BMR-2026-0908Investigator: Sana Iqbal
DEV-2026-0046Critical

Autoclave cycle #12 thermal probe temperature discrepancy

Batch: BMR-2026-0911Investigator: Fatima Noor

Market Authorizations & RIMS Commitments

28 Dossiers
DRAP-REG-004921-VAR-04
DRAP Pakistan • Variation (Major)
Approved
DRAP-REG-005112-REN
DRAP Pakistan • Renewal
Under Review
MHRA-CTD-2026-018
UK MHRA • eCTD Module 3
Query Response

Simulated SHA-256 Audit Trail Stream

Demo Ledger
2026-10-14 11:30:007f83b1657ff1fc...
QP Final Regulatory Release Disposition
Actor: Dr. Ayesha Khan • Target: BX-2026-0891
2026-09-20 16:00:003a88c392c0bdf0...
Deviation Investigation Closure Sign-Off
Actor: Dr. Ayesha Khan • Target: DEV-2026-0042
2026-09-15 10:15:0082a98fbd9265f8...
Deviation Logged & Temporary QA Hold Initiated
Actor: Fatima Noor • Target: DEV-2026-0042
2026-10-05 12:15:00hash_00004988_...
QC Result Verification
Actor: Hina Tariq • Target: BMR-2026-0911