http://www.campbellinformatics.com/blog life science quality engineering data management - Facilities - Processes - People -Product Fri, 09 Nov 2007 09:20:40 +0000 http://backend.userland.com/rss092 en Intrinsic Safety is a protection technique for safe operation of electronic equipment in hazardous atmospheres. The underlying principle is to ensure that the available electrical and thermal energy in the system is always low enough that ignition of such hazardous atmosphere cannot occur. Note that no single component or circuit ... http://www.campbellinformatics.com/blog/intrinsic-quality/ The design of the ‘Biopharma Quality Engineering Data Management’ program in the Avenio engine facilitates the portrayal of plant processes in producing safe, pure and efficacious products. The process streams are supported by plant, facilities and systems whose attributes are all individually risk assessed by virtue of their inclusion based ... http://www.campbellinformatics.com/blog/quality-risk-management/ This recently published ASTM guide defines a risk-based and science-based approach to the specification, design and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment. It is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: facility equipment, process equipment, supporting utilities, monitoring & control systems and automation ... http://www.campbellinformatics.com/blog/astm-e2500-standard-guide/ UCC's School of Pharmacy and Campbell Informatics have entered into a 2-year E.I. sponsored Innovative Partnership Project, effective August 2007. The project – ‘BioPharma Quality Engineering Data Management’ - involves the compilation of interdisciplinary datacentric standards within the Avenio engine. The project is targeted towards the heavily regulated and paper dependent ... http://www.campbellinformatics.com/blog/biopharma-quality-engineering-data-management/ There are a number of interpretations of the term ‘lifecycle’, ranging from NIPTE’s all-encompassing Design-Development-Manufacturing on the one hand, to ISPE’s more focused Commissioning & Qualification on the other. My contention is that within the transition state, Lifecycle Unification principles can be applied to simple and complex situations alike; complex lifecycles ... http://www.campbellinformatics.com/blog/18/ Your filter may have a different pore size to mine, your column a different resin, and your temperature control sequence a different ramp rate; but filters are filters, columns are columns and controllers are controllers, in the overall scheme of things.  So long as we can nominate context-specific target values for ... http://www.campbellinformatics.com/blog/classes-are-classy/ There is a longstanding Lifecycle Unification problem relating to Bills of Material, known in Industrial Engineering circles as the multiple BOM reconciliation problem. The difficulty is this: any reasonably complex system has not one, but several BOMs, each representing a distinct configuration of the system across its lifecycle (e.g. as-required, as-specified, ... http://www.campbellinformatics.com/blog/multiple-bills-of-material/ In this message I want to introduce the concept of Quality by Design (QbD) arrays. Since I want to accentuate the positive here, I won’t dwell too long on ‘disarray’, other than to say that it’s a fair description of the current state. We’ve already introduced the concept of System ... http://www.campbellinformatics.com/blog/array-vs-disarray/ MIT has identified the field of Engineering Systems as a missing-link discipline which precedes and facilitates traditional engineering, particularly when dealing with complex implementations and infrastructures. Given the intricacies of pharmaceutical technology and the emergence of PAT etc., their monograph on The Influence of Architecting in Engineering Systems is a very ... http://www.campbellinformatics.com/blog/the-ilities/ Following on from my previous message in support of standardization, I cannot understand why each phase and sub-phase of the lifecycle deserves its own data/documentation format. The way I see it, each and every ‘regulated technical element’ needs to be explicitly (i) identified, (ii) specified and (iii) supported by a ... http://www.campbellinformatics.com/blog/formats/