GOOD PRACTICES FOR DATA MANAGEMENT AND …

PI 041-1 (Draft 3) 1 of 52 30 November 2018 PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME 1 PI 041-1 (Draft 3) 2 30 November 2018 3 4 5 6 7 8 9 PIC/S GUIDANCE 10 11 12 13 14 good PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS 15 16 17 18 19 20 21 PIC/S November 2018 Reproduction prohibited for commercial purposes. Reproduction for internal use is authorised, provided that the source is acknowledged. 22 23 24 25 26 Editor: PIC/S Secretariat e-mail: web site: 27 28 PI 041-1 (Draft 3) 2 of 52 30 November 2018 TABLE OF CONTENTS 29 Page 30 31 1. Document history .. 3 32 2. Introduction .. 3 33 3. Purpose .. 4 34 4. Scope .. 5 35 5. Data governance system .. 5 36 What is data governance? .. 5 37 Data governance systems .. 5 38 Risk MANAGEMENT approach to data 6 39 Data criticality.

manufacturing (GMP) and distribution (GDP) activities, although this will be limited 2. PIC/S PE 009 Guide to Good Manufacturing Practice for Medicinal Products, specifically Part I chapters 4, 5, 6, Part II chapters 5, 6 & Annex 11 3. PIC/S PE 011 Guide to Good Distribution Practice for Medicinal Products, specifically sections 3, 4, 5 & 6

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