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CYTOWELL SDN BHD (CTSB)

CYTO-11 — Balakong Jaya

EQUIPMENT MAINTENANCE & CALIBRATION RECORDS (8.2)

Doc NoCTSB-ENG-REG-8.2
Rev02
Effective2026-01-02
Page1 of 2

Period 2026-01-01 → 2026-07-07 · Site CYTO-11 · printed 2026-07-07 by Leo Lim

Date Ref # Type Asset Details Result By Verified
2026-07-07 CAL-26-078 Calibration CP-01 Capsule Filler NJP-1200 6-monthly dosing disc calibration — was due 2026-06-25 (12 d overdue), done inside today's PM Partial — pending QC check Faizal (ENG)
2026-07-07 CAL-26-077 Calibration QC-01 Checkweigher Daily weight verification vs standard weights — within ±0.1 g Pass Ahmad (OP) Lee (QC)
2026-07-06 MWO-26-034 Breakdown FL-02 Sachet Filling Line 2 Dosing pump failure — part ordered ETA 2026-07-08; machine Down, 2 MOs blocked Waiting part Faizal (ENG) Sarah (FM)
2026-07-01 CL-26-0890 Cleaning FL-01 Sachet Filling Line 1 Allergen changeover clean milk → allergen-free; swab test pass Pass Lee (QC) Farah (QA)
2026-06-14 PM-26-102 Preventive MX-01 Ribbon Blender 300L Monthly PM — lubrication + belt check; next due 2026-07-14 Done Faizal (ENG)

Prepared by — system print, Leo Lim 2026-07-07

Reviewed by ENG — Faizal (wet-ink)

Approved by QA — Farah (wet-ink)

Wet-ink signatures required — paper-parallel.

CYTOWELL SDN BHD (CTSB)

CYTO-11 — Balakong Jaya

PREMISES RECORDS (10.2)

Doc NoCTSB-QA-REG-10.2
Rev02
Effective2026-01-02
Page2 of 2

Period 2026-01-01 → 2026-07-07 · Site CYTO-11 · printed 2026-07-07 by Leo Lim

Date Ref # Type Asset Details Result By Verified
2026-07-07 TH-26-1188 Temp-Humidity Packing Room PM 29.2 °C / 71 % RH above limits (18–28 / 40–65) — MWO-26-031 linked Alert Ahmad (OP)
2026-07-07 CL-26-0912 Cleaning Mixing Room Routine AM clean — all items pass Done Ahmad
2026-07-05 SAN-26-031 Sanitation Production drains Fogging, QuatSan 2% — QA verified Done Ahmad Farah (QA)
2026-07-04 INS-26-027 Inspection CYTO-11 whole site Weekly GMP walk-down — 2 minor findings (→ MWO-26-032, FG Store pallet spacing) Partial Farah (QA)
2026-07-03 PEST-26-066 Pest Bait stations ×12 Internal round — no activity Clear Ahmad
2026-07-02 CL-26-0894 Cleaning Mixing Room Weekly deep clean + drain sanitization — wet-ink QA sign kept Done Ahmad Farah (QA)
2026-06-30 INS-26-026 Inspection CYTO-11 Monthly GMP inspection, 7-category checklist — all pass Pass Farah (QA)
2026-06-28 PEST-26-064 Pest Rentokil service visit Bait refresh, trend report + SDS filed Clear Faizal (ENG)
2026-06-27 CL-26-0871 Cleaning FG Store & raw mat rooms Weekly clean + spillage check Done Ahmad
2026-06-20 SAN-26-027 Sanitation RO water system Sanitization + micro sampling — lab result within limits Pass Lee (QC)

Prepared by — system print, Leo Lim 2026-07-07

Reviewed by ENG — Faizal (wet-ink)

Approved by QA — Farah (wet-ink)

Wet-ink signatures required — paper-parallel.