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EUROTHERM® FLEXIBLE SOLUTIONS Pharma Reference Guide ■Global expertise and expe

EUROTHERM® FLEXIBLE SOLUTIONS Pharma Reference Guide ■Global expertise and experience in providing Pharmaceutical and Biotech solutions ■Proven track record in rapidly delivering solutions with optimum ROI ■More than 40 years experience in control, data management and scalable automation solutions ■Cost-effective solutions to improve the reliability and efficiency of your processes throughout their life cycle ■Proven experience in working and integrating with multiple suppliers and platform ■Specialist teams with comprehensive experience in validating systems ■Global expertise, local supply and support ■A team to work with your team, a partnership for success Documentation ■Life Sciences Catalogue ■Life Sciences Brochure ■Building Management Systems & Environmental Monitoring Systems Brochure ■Eycon Brochure ■6000 Series Brochure ■6000 Series Recorders and 21 CFR Part 11 ■3000 Series Brochure ■2000 Series Brochure Visit www.eurotherm.co.uk/products to download EUROTHERM® FLEXIBLE SOLUTIONS Life Sciences EUROTHERM Pharma Reference Guide Introduction HA029969 Issue 1 Sept 08 1 Introduction FOR EUROTHERM the definition of Life Sciences covers the following market areas: We have been active within all of these industries for many years and together they constitute a complete global business unit. The purpose of the ‘Pharma Reference Guide’ is to provide our customers categorised within all the sectors above with a broad overview of the business and legislative issues that we consider significant and which play a major role in governing the marketing input and subsequent R&D activities within our company. The ‘Pharma Reference Guide’ was originally published for use as an internal training document within our business unit but we have also used it for customer training and it is because of the feedback from our customers that we decided to publish the document. We hope that you will find it a useful digest of the pharmaceutical business and that you will consider Eurotherm for future projects within your company. Pharmaceutical Medical Devices Healthcare Cosmetics EUROTHERM Pharma Reference Guide 2 HA029969 Issue 1 Sept 08 Jargon Buster 21 CFR Part 11 FDA’s regulation on Electronic Records and Electronic Signatures ABPI Association of the British Pharmaceutical Industry Annex 11 Good Manufacturing Practice for Computerised Systems (Europe) API Active Pharmaceutical Ingredient CFR Code of Federal Regulations (FDA regulations are all in 21 CFR) CTD Common Technical Document (international format for new drug submissions) EMEA European Medicines Evaluation Agency (EEC Regulator) FDA Food and Drug Administration (US Regulator) GAMP Good Automated Manufacturing Practice as described in GAMP5: A Risk-Based Approach to Compliant GxP Computerised Systems GCP Good Clinical Practice GDP Good Distribution Practice GHTF Global Harmonisation Task Force GLP Good Laboratory Practice GMP Good Manufacturing Practice GxP/cGxP Current Good Practice HC-SC Health Canada – Santé Canada (canadian Regulator) HVAC Heating, Ventilation and Air Conditioning Systems ICH International Conference on Harmonisation IQ Installation Qualification MCC Medicine Dictionary for Regulatory Activities (MedDRA) MedDRA Medicines and Healthcare Products Regulatory Agency (UK Regulator – formerly the MCA and the MDA) MHLW Ministry of Health, Labour and Welfare (Japanese Regulator) MKT Mean Kinetic Temperature NIHS National Institute of Health Science (Japanese Regulator) OQ Operational Qualification PAT Process Analytical Technology PhRMA Pharmaceutical Research and Manufacturers of America PIC/S Pharmaceutical Inspection Convention/ Pharmaceutical Inspection Co-operation Scheme PQ PQ Performance Qualification SOP Standard Operating Procedure TGA Therapeutic Goods Administration ( Australian Regulator) URS User Requirements Specification VMP Validation Master Plan WFI Water For Injection EUROTHERM Pharma Reference Guide Introduction HA029969 Issue 1 Sept 08 3 Contents 1 Healthcare Industries Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 2 Regulators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 3 Life-cycle of a Drug “Test Tube to Tablet” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 4 Manufacturing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 4.1 Active Pharmaceutical Ingredients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 4.2 Secondary Manufacture. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 4.3 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 4.4 Biotechnology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 4.5 Services. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 4.6 Stability Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 5 The FDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 5.1 ‘Predicate Rules’. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 5.2 21CFR part 11 and electronic records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 5.3 21 CFR part 11 and electronic signatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 5.4 The ‘PAT’ initiative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 6 The EMEA and ‘Annex 11’ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 7 GAMP5 . . . . . . . . . . . . . . . . . . . . uploads/Industriel/ pharma-ref-guide.pdf