Annexure III · Finished product
Bleomycin for Injection
The same road as Annexure I, after the campaign has been filled and tested.
pH
4.5 – 6.0
empty road
Water content
NMT 6%
empty road
Uniformity of dosage units
NMT 15.0
empty road
Assay
90 – 110%
empty road
Bleomycin A2
55 – 70%
empty road
Bleomycin B2
25 – 32%
empty road
Bleomycin B4
NMT 1.0%
empty road
A2 + B2
NLT 85%
empty road
Sub-visible 10 µm
NMT 6000
empty road
Sub-visible 25 µm
NMT 600
empty road
Enter a lot · Annexure III
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