Decoding the Methodology Minefield

Methodologies are certainly a minefield of regulations, acronyms and terminology; and that’s even before you get into what it all means, how to implement them or how to manage change.

Let’s start with the regulations. Whether you are talking about manufacturing or shipping, there are certain regulations that apply. In terms of labeling, the US FDA regulations are the most onerous, so if you can meet these you are generally equipped to meet any others you come across (including EU and MHRA regulations).

Acronyms can add a layer of complexity, since they can be very similar with only slight variations on each other, such as cGMP, GMP, GAMP and GxP. Fortunately, there are some standard letters that are used, which makes deciphering some of these acronyms a bit easier. For example, ‘G’ is often used for Good and ‘P’ for Practice or Practices. Another commonly featured letter is the lowercase ‘c’ which stands for Current if it’s at the beginning of the acronym. When ‘A’, is found in the middle of the acronym it’s for Automated, followed by the area that is represented, such as ‘M’ for Manufacturing, ‘C’ for Clinical and ‘L’ for Laboratory. Collectively these are all known as GxP, where the ‘x’ in the middle indicates there are many different unique areas the overriding methodology can be implemented into.

When you get further into your project you will likely need to enforce control and manage change by utilizing either Software Development Implementation and Maintenance (SDIM) or Systems/Software Development Lifecycle (SDLC). They both include a detailed Computer Systems Validation and a Change Control process to ensure safe and efficient management. Both SDIM and SDLC cover the full project lifecycle from the initial idea through design, test, deployment, (including any iteration for change) and the final phase. The change management process has its own set of relevant terms, starting with Continuous Improvement, Kaizen or Six Sigma, all of which aim at long term improvements in an operational or manufacturing process. If an issue is uncovered, a different set of tools and techniques can be used to investigate and remove or rectify the issue. These include Root Cause Analysis, Corrective and Preventative Action (CAPA), and Poke-Yoke (Japanese technique also called Error Proofing).

A Quality Assurance and/or a Quality Management System will help you deal with the overall aspects of planning and control and should incorporate the relevant GxP methodologies as well as some tools and techniques used within the change management process. Relevant accreditations, for example ISO, will fall into this area.