🔬 HPLC System Suitability (SST)
Why this is needed: Per FDA and USP <621> regulations, QC Analysts must mathematically prove the HPLC/GC machine is highly precise before testing actual medicine. If the RSD is too high, the test is legally invalid.
🧪 HPLC Analytical Assay %
Why this is needed: The core formula of a QC lab. Determines the exact concentration of raw APIs and finished tablets to ensure patients receive the correct medical dose.
Assumes equal dilution volumes for standard and sample.
📅 QC Stability Pull Scheduler
Why this is needed: FDA ICH Q1A guidelines require precise interval testing to prove a drug's expiry date. Missing a pull date by even a few days can invalidate millions of dollars of product.
- Month 1 to 3: strict ± 3 Days
- Month 6 to 12: allowed ± 7 Days
- Month 24+: allowed ± 14 Days
Mandatory Pull Dates:
☑️ Master Batch Record (BMR) Release
Why this is needed: CFR 211.192 mandates that the Quality Assurance unit must independently review and sign off on all production and lab records before a drug can be legally sold.
📋 FDA Inspection Readiness Scorecard
Why this is needed: Unannounced FDA/EMA audits can result in factory shutdowns (Form 483 Warning Letters). QA evaluates these 5 primary compliance pillars weekly to ensure audit-readiness.
💊 AQL Sampling Standard (ISO 2859-1)
Why this is needed: You cannot physically test 50,000 tablets. ISO 2859-1 dictates the mathematically minimum sample size required to statistically prove the entire batch is safe, providing legal Accept/Reject thresholds.
📊 USP Content Uniformity (AV)
Why this is needed: USP <905> mandates that tablets in a batch must be uniformly mixed. The "Acceptance Value" proves consistency using a rigorous statistical k-factor.
📈 Six Sigma Cpk Process Capability
Why this is needed: QA uses Cpk during process validation to mathematically prove that a tablet press or filling machine will consistently produce drugs within FDA limits without producing defects.
💧 LOD % Moisture Calculation
Why this is needed: If wet powder is compressed into tablets, the batch will literally crumble or stick to the machine punches. Loss on Drying proves the moisture was safely evaporated.