Annexure II · Critical process parameters
Bleomycin for Injection
Min and max of the run. Each lot is a span. Footer is Mean / Min / Max / Limit — no Cpk.
Tunnel temperature
300 – 350°C
empty road
Fill volume
1.0 – 1.2 ML
empty road
Filling room temperature
22.0 – 28.0°C
empty road
Relative humidity
NMT 60%
empty road
∆P filling LAF
10 – 20 MM OF WATER
empty road
Enter a lot · Annexure II
You may walk this road but not drive it. Ask a QA Recorder to enter the lot.
How to read the road
Each mark is a lot. The painted lines are the specification — a solid line is a limit you must not cross, a broken line is open ground.
Smear is rate of room change — the road’s sustained trend, never lot-to-lot noise. Red is room being spent, or a line already crossed. A still road is crisp and countable.
Acceptance lives in the footer, never typed: Cpk greater than 1.33 and Sigma greater than 3.0. If every lot is identical, SD is stillness and the figures read NA.
The GMP table is the record, and it is always one toggle away. This drawing is the world of the annex.
Without leaving the keyboard: 1–5 open the annexures by their own numerals, t opens the trail, and h returns to the house. They are deliberately written down rather than left to be found: an undocumented interaction in a record system is a finding waiting to happen.
Gati · the road of the campaign · footer computed at draw time, never stored