Data Management for PAT, IT infrastructure, MVDA (online/offline, product lifecycle)

Data Collection, Processing and Use In-Process WATER 5 4 FROM WAREHOUSE 2 1 3 150 kG/h 20n MICRON 123°C 4 HOUR SP WASTE FS +15°C 7 Additive 1 130 MINUTES Additive 2 5 min. Additive 3 10 min. +5°C 9 100°C 155°C 180°C 145°C 165°C 150°C 12 min 30 3 min 15 0,6 m/min 10 11 13 12 14 S1 S2 B1 B2 F1 F2 B3 15°C - 10 MINUTES B5 P1 W1 ROLL Kg SECONDARY 0,8x40 mm PROCESSING S3 6 4 TRAYS : 8xx MICRON 6xx MICRON 4xx MICRON 8 2xx MICRON 61% 39%

Data Collection, Processing and Use In-Process WATER 5 4 FROM WAREHOUSE 2 1 3 150 kG/h 20n MICRON 123°C 4 HOUR SP WASTE FS +15°C 7 Additive 1 130 MINUTES Additive 2 5 min. Additive 3 10 min. +5°C 9 100°C 155°C 180°C 145°C 165°C 150°C 12 min 30 3 min 15 0,6 m/min 10 11 13 12 14 S1 S2 B1 B2 F1 F2 B3 15°C - 10 MINUTES B5 P1 W1 ROLL Kg SECONDARY 0,8x40 mm PROCESSING S3 6 4 TRAYS : 8xx MICRON 6xx MICRON 4xx MICRON 8 2xx MICRON 61% 39% CQA1 CQA2 CQA4 CQA3 CQA4

Data Collection, Processing and Use In-Process WATER 5 4 FROM WAREHOUSE 2 1 3 150 kG/h 20n MICRON 123°C 4 HOUR SP WASTE FS +15°C 7 Additive 1 130 MINUTES Additive 2 5 min. Additive 3 10 min. +5°C 9 100°C 155°C 180°C 145°C 165°C 150°C 12 min 30 3 min 15 0,6 m/min 10 11 13 12 14 S1 S2 B1 B2 F1 F2 B3 15°C - 10 MINUTES B5 P1 W1 ROLL Kg SECONDARY 0,8x40 mm PROCESSING S3 6 4 TRAYS : 8xx MICRON 6xx MICRON 4xx MICRON 8 2xx MICRON 61% 39% CQA5 CQA5 CQA4 (FF) CQA1 CQA6 CQA2 CQA3 CQA4

Data Management – The Key Questions 1. How much data do we collect from the process ? (Sampling Strategy ?, Process Speed ?, Control Requirements?, Instrument Limitations? …..) 2. At what speed do we process the data ? (Real-Time?, In-Process?, Off-Line? …. What is ‘real-time’ for the process? How complex is the processing? …..) 3. What data do we store ? (Raw?, Reference?, Intermediate?, CQA?, Batch?, Historical? …..) 4. How long do we keep the data ? (End of Batch?, Rolling pre-defined period?, 10 years?, After product removed from market?, …..)