All about Pharmaceuticals & Medical Devices
Management of Operations & Quality through Statistical Tools
Operational Excellence in Sterile Manufacturing | OEE & Line Productivity Every sterile manufacturing site eventually hits the same wall. Demand rises, the filling line is already booked solid, and the obvious levers (more shifts, more speed) either aren’t available or put sterility assurance at risk. Yet when we study where time actually goes on an …
Continue reading “Faster Without Compromise: Reclaiming Capacity on Sterile Fill-Finish Lines”
1. 🧪 Quality & Compliance (Critical for Injectable Sites) KPIDefinitionTargetFrequencyOwnerBatch Rejection Rate% of batches rejected vs total manufactured≤ 0.5%MonthlyQA HeadOOS (Out of Specification)No. of OOS per 1000 tests↓ TrendWeeklyQC HeadOOS Closure TATAvg. days to close OOS≤ 30 daysWeeklyQARight First Time (RFT)% batches released without deviation≥ 98%MonthlyProductionSterility Failure RateFailures in sterility tests0MonthlyMicrobiologyAudit ObservationsNo. of critical/major findings0 …
Continue reading “đź’‰ Injectable Site – Operational Excellence KPI Dashboard”
OE Perspective with Real Case Study 1. The Strategic Context: Why QC & QA Need Transformation In leading pharmaceutical organizations, QC and QA are often the longest poles in the tent when it comes to product release. Despite high investments in systems like LIMS, TrackWise, and SAP, many companies still face: Batch release cycles of …
Continue reading “How Value Stream Mapping (VSM) Transforms QC and QA Efficiency in Pharma”
In most pharmaceutical QC and analytical laboratories, HPLC systems are the backbone of release, stability, and development testing. Yet, when it comes to maintaining these critical assets, organizations often default to a simplistic decision: AMC or CMC? That approach is outdated—and expensive. A modern Operational Excellence (OE) perspective reframes the question entirely. The real decision …
In most pharmaceutical QC laboratories, HPLC systems are treated as critical but constrained assets. Despite heavy investments in instrumentation, labs continue to struggle with delayed sample release, long queues, and reactive firefighting. The root problem isn’t always capacity—it’s lack of visibility into losses. This is where HPLC Overall Equipment Effectiveness (OEE) becomes a powerful Operational …
“If I had an hour to solve a problem, I’d spend 55 minutesthinking about the problem and 5 minutes thinking about solutions.” -Albert Einstein We know lot of tools used for root cause analysis and Kepner and Fourie is one of most powerful tool when we don’t know the real cause of a problem. The …
Continue reading “The KEPNER and FOURIE™ Thinking Processes”
If you are unable to understand the cause of a problem it is impossible to solve itNaoto Kan Now a days pharmaceutical and medical devices industries are getting more number of form-483 from USFDA, due to inadequate investigation of the problems and some time lead to voluntary action(import alert,warning letter) to the manufacturing sites. “The …
