Transcription of GMPの概要、文書化及び教育訓練 - pref.kyoto.jp
1 GMP GMP 2 GMP GMP administrativeGMP 31 (production) (manufacturing and packaging operations) (control) (storage) (shipment) GMP 41 GMP GMP QMS ISO14001 GQP GVP GMP 5 GMP 6 GMP ISO GMP 7 GMP ISO GMP 8 GMP 1.
2 2. 3. GMP 9 GMP GMP 1117 GMP 12 GMP 1317 GMP QMS 90 3 GQP 5 GMP (procedure) (instruction) (specification) (protocol) (report) (method) (record)
3 GMP a) b) c) d) e) f) GMP a) b) c) d) GMP GMP 18 D-16-004-001 ( .. ) ( .. ) ( .. ) GMP GMP 20 GMP 21 (5W1H)
4 3 GMP GMP Top management GMP GMP GMP GMP top management GMP top management Top Management QMS GMP 27 Top Management GMP GMP ICH Q10 GMP 28 Top Management GMP Top Management QMS 10 ( ISO9001) GMP 29 QMS Top Management 1.
5 2. 3. (=Management Review)4. 5. GMP 30 Management ReviewQMS 18 1. 2. Top Management Top Management GMP GMP 31 Management Review Input 1. 2. 3. 4. 5. 6. 7. 8. GMP 32 Management Review Output 1. 2. 3.
6 GMP GMP 34 GMP 35 GMP a) b) c) d) e) f) GMP 38 GMP 39 GMP GMP 40 GMP Management Review Top Management Top Management
7 GMP GMP GMP GMP GMP GMP GMP 47 GMP 48 GMP 49 GMP 51 GMP 52 GMP GMP 53 OJT GMP GMP 54
8 GMP 55 1. GMP GMP 2. 3. OJT GMP 56 1. 2. 3. GMP 57 GMP 58
