Non Conformities raised during HSA GMP Audit 2013: Level 2: Level 4: Level 5: Level 6: Approved Packaging Material

Approved Packaging Material Area Seal of floor gap Clean status label: Validity of clean status before re-cleaning Digital Platform Balance: Level of balance? Firm? Air Bubble? Require maintenance Suggestion: Caps for Weighing Drums (where to place during dispensing), roller on the weighing balance safety concern Mixing Tank 1: Vent filter any filtering element, installation (control panel etc) not stable Air conditioner and shield for lighting source of contamination and safety issue Accuracy of pouring of raw materials weighed into the tank Additional headcount minimise error in weighing (Mr. Sim to perform the dispensing and recording at the same time Suggestion: Use of pipeline to introduce liquid raw materials, with calibrated flowmeter to indicate flow and verify amount dispense using load cell Mixing Tank 2: too low safety concern Cleaning form: Indicate area where cleaning is done; Mr. Sim to specify date where verify cleaning 2 IBC drums of Liquid Paraffin without QC Approved labels 1 cap for Levomenthol spoilt and is pasted onto the drum with tape Baits? Date of changes? CUNO filter 2 boxes; one opened and exposed; placed next to raw materials lavender oil Fan/ exhaust in store: dusty, cleaning not done? Temperature excursion Storage of Reference Materials better location? Sampling labels for B2(TW)-13-01 not indicated on pallet Baits only 1 and is discarded without replacement Wooden block and door strap for glass doors Pipes dusty and not cleaned contract to external cleaners? Cleaning sheet sign but no indication of activities for 3 dates Cleaning sheet for 1 store (2nd store?) Connecting door bet 2 stores should be locked Dirty plastic pallets/ floor and wooden pallets in approved packaging materials area Paint peeling off from walls (approved packaging materials area) Packaging for SGD bottles protection from contamination? Temperature excursion

 QC:

Gate valve for Mixing tank 1 is rusty Preventive maintenance: Teflon seal, Ferrule Gasket Door to mixing room out of alignment Master Formula: extra decimal place for weighing of raw material balance not able for such accuracy Wooden handle of equipment to open drum? Filling of holes at Filling/ Packaging Room? Rusty ferrule at Filling Tank A and pipe at Filling Tank B Suggestion: Control on label pasting, parafilm

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