|
LIFESCIENCE ENGINEERING: the way it should be
Regulation
FDA and other regulators are pursuing risk-based regulatory strategies derived from a number of emerging guidances and initiatives. From an FDA perspective, this is occurring in conjunction with the drive towards systems-based inspections aimed at the following aspects of manufacture:
Facilities & Equipment
Materials
Production
Packaging & Labeling
Laboratory Controls
Quality-by-Design and Process Understanding have also been identified as key constituents of 21st Century GMP.
Manufacturing
In addition to regulatory compliance, speed-to-market, continuous improvement and cost-effectiveness are key issues for pharmaceutical manufacture. In spite of these drivers, inefficient manual techniques remain the norm within the Commissioning & Qualification (C&Q) and aftercare lifecycle. There has to be a better way.
Modularity
Modularity provides a simple but powerful mechanism for lean C&Q. This involves the structured acquisition & reutilization of technical knowledge, regardless of scale. Relevant aspects of modularity include:
Systems are assemblies of interconnected technical components
Components can be physical, functional or parametric
Tasks can be prioritized based on system component risk
Protocols are transient, but data endures
Single inputs drive multiple outputs
Our Offering
Working in collaboration with an established manufacturing clientele and based on a 20-year track record within the industry, Campbell Informatics has developed a rapid C&Q framework utilizing the above principles. The framework is delivered as a technical support service in combination with software licenses as appropriate, and is aimed at organizations seeking standardization and economy within the C&Q and aftercare lifecycle.
Our Mission
Intrinsic compliance.
|
