ALL DOCUMENTS ARE WRITTEN USING MS WORD OR EXCEL. THEY CARRY NO ADVERTS AND ARE 100% EDITABLE. WHEN YOU PURCHASE A DOCUMENT FROM THIS SITE YOU WILL AUTOMATICALLY BE SENT A URL LINK TO DOWNLOAD YOUR DOCUMENT. THESE URL LINKS ARE AROUND 130 CHARACTERS LONG AND IT IS ESSENTIAL THEY ARE NOT BROKEN.
Validation Online; is part of the AKC group which has over fifty years experience of QA & QC Implementation tasks and ten years of direct internet documentation sales.
503B Outsourcing Facility validation package of protocols.
Validation Online has been supplying interactive validation protocol templates for over sixteen years. These templates are widely used throughout the Bio-Med industries and carry our unconditional guarantee of being fit-for-purpose.
From 2013 the FDA designated 503B Dispensing Pharmacies as “Outsourcing Facilities” that may produce large batches of regulated product with or without prescriptions to be sold to healthcare facilities. 503B approved facilities are required to maintain full compliance with current good manufacturing practices (CGMP), I.E. the ensuing steps for dispensing, mixing or blending, filtration, compression or filling, container closure system (CCS) filling, coating, polishing, device filling, and packaging of a drug product must occur under a strict CGMP systems of controls.
This document contains a generic Design Qualification (DQ) (Pages 4 to 28) along with instructions, in the form of an SOP (pages 1 to 3), on how, using the SOP sheets, to change this generic DQ into a bespoke DQ for the equipment you require to validate. Once these instructions are completed and the generic DQ has been fully populated, the SOP pages 1 to 4 are deleted and the DQ becomes a stand-alone bespoke document.