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Pharma ref guide EUROTHERM FLEXIBLE SOLUTIONS Pharma Reference Guide CEUROTHERM FLEXIBLE SOLUTIONS Life Sciences ? Global expertise and experience in providing Pharmaceutical and Biotech solutions ? Proven track record in rapidly delivering solutions with

EUROTHERM FLEXIBLE SOLUTIONS Pharma Reference Guide CEUROTHERM FLEXIBLE SOLUTIONS Life Sciences ? Global expertise and experience in providing Pharmaceutical and Biotech solutions ? Proven track record in rapidly delivering solutions with optimum ROI ? More than years experience in control data management and scalable automation solutions ? Cost-e ?ective solutions to improve the reliability and e ?ciency 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 ? Series Brochure ? Series Recorders and CFR Part ? Series Brochure ? Series Brochure Visit www eurotherm co uk products to download CEUROTHERM Pharma Reference Guide Introduction Introduction FOR EUROTHERM the de ?nition of Life Sciences covers the following market areas Pharmaceutical Medical Devices Healthcare Cosmetics 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 signi ?cant 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 ?nd it a useful digest of the pharmaceutical business and that you will consider Eurotherm for future projects within your company HA Issue Sept CEUROTHERM Pharma Reference Guide Jargon Buster CFR Part ABPI Annex API CFR CTD EMEA FDA GAMP GCP GDP GHTF GLP GMP GxP cGxP HC-SC HVAC ICH IQ MCC MedDRA MHLW MKT NIHS OQ PAT PhRMA PIC S PQ SOP TGA URS VMP WFI FDA ? s regulation on Electronic Records and Electronic Signatures Association of the British Pharmaceutical Industry Good Manufacturing Practice for Computerised Systems Europe Active Pharmaceutical Ingredient Code of Federal Regulations FDA regulations are all in CFR Common Technical Document international format for new drug submissions European Medicines Evaluation Agency EEC Regulator Food and Drug Administration US Regulator Good Automated Manufacturing Practice as described in GAMP A Risk-Based Approach to Compliant GxP Computerised Systems Good Clinical Practice Good Distribution Practice Global Harmonisation Task Force Good Laboratory Practice Good Manufacturing Practice Current Good Practice Health Canada ?? Santé Canada canadian Regulator Heating Ventilation and Air Conditioning Systems International Conference on Harmonisation Installation Quali ?cation Medicine Dictionary for Regulatory Activities MedDRA Medicines and Healthcare Products Regulatory Agency UK Regulator ?? formerly the MCA and the MDA Ministry of Health