QA

Quality Management (QM) & cGMP Lab Dashboard

ECC T-Codes: QA32 / QE51N / QA03

Analytical release testing, Certificates of Analysis (CoA), In-Process Quality Control (IPQC), and stability chambers.

PIC/S Lab Status:Zero Critical Deviations
CoA Turnaround
18.4 Hours-2.2h
Sample to signoff<24h
Right First Time
99.2%+0.4%
Assays passed 1st run>98.5%
Active OOS Incidents
0 Open0
Zero deviationsLimit: 0
Stability Chambers
48 Batches+3
ICH zone conditions100% On-Time
In-Process Lots
14 Lots+1
IPQC testing queueActive
Micro Testing Passed
100%0
Bioburden & endotoxinSterile
HPLC/GC Uptime
98.6%+0.8%
Chromatography systems>95%
cGMP Audit Score
Grade A0
Regulatory compliancePIC/S / FDA

Inspection Lot Disposition & Release Breakdown

Real-time status of commercial batch release dossiers

100% Compliant
Released (CoA Ready): 76%
In-Process Testing: 14%
Stability 3M/6M: 8%
Pending Review: 2%

Inspection Lots & Analytical Testing Queue

(5 Inspection Lots)
Inspection LotSample Material DescriptionBatch NumberQC StageAssay ProgressTATLead AnalystCoA StatusLot Disposition
QL-09941Paracetamol 500mg (Batch BMR-2610-A14)BMR-2610-A14In-Process QC6 / 6 Tests8.5 hrsDr. M. Santos, RChPending SignoffCompliant
QL-09938Sterile Water for Injection (Batch BMR-2610-S01)BMR-2610-S01Finished Product Release8 / 8 Tests48 hrsK. Villanueva, Micro Lead Signed & IssuedReleased (CoA Ready)
QL-09945Amoxicillin Trihydrate Compacted BP Raw APILOT-INSP-AMX-99Raw Material Testing4 / 5 Tests14.2 hrsR. Tan, Analytical ChemistPending SignoffPending Review
QL-09920Ascorbic Acid + Zinc Tablet 500mgBMR-2609-V12Stability Chamber 3M7 / 7 Tests72 hrsA. De Leon, Stability Head Signed & IssuedCompliant
QL-09950Hard Blister Foil Lot 25mc PrintedLOT-ALU-089Raw Material Testing2 / 3 Tests6 hrsJ. Corpuz, Packaging QAPending SignoffPending Review