PDF-Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics

Submit electronic comments to httpwwwregulationsgov Submit written comments to the Division of Dockets Management HFA305 Food and Drug Administration 5630 Fishers Lane rm 1061 Rockville MD 20852 All comments should be identified with the docket num. Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit written comments to the Di vision of Dockets Mana Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic com ments to httpwwwregulationsgov Su Comments and suggestions regarding this draft document should be submitted within 60 calendar days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Mana Comments and suggestions regarding this draft document should be submitted within 60 calendar days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Mana Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub omments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Subm Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to th e Division of Dockets Management H Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Subm Comments and suggestions regarding this draft docu ment should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Management H a Virtual Biologics Clinic. Dr Ben Parker PhD, MRCP. Consultant Rheumatologist, Manchester Royal Infirmary. Honorary Senior Lecturer, University of Manchester. To cover. Why the need for innovation in biologics services?. BY . Dr. . Alka. N . Choudhary. Division of Pharmaceutical Sciences. S.G.R.R.I.T.S., Patel Nagar, Dehradun (UK). “. Validation of an analytical procedure is the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for its intended use.”. BY . Dr. . Alka. N . Choudhary. Division of Pharmaceutical Sciences. S.G.R.R.I.T.S., Patel Nagar, Dehradun (UK). “. Validation of an analytical procedure is the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for its intended use.”. What does personalisation . mean . for you?. Ian N Bruce. Kellgren. Centre for Rheumatology. NIHR . Manchester Biomedical Research . Centre University of Manchester . @. Lupusdoc. Manchester University Hospitals NHS Trust and University of Manchester.