Diagnosis: Acronymitis... Janice Bennett-Livingston Published: May 2, 2014 Industrial Manufacturing and Processes Industrial Measurements Life Science AKA: Acute Swelling of the Acronyms. Acronyms are rampant. In our language, our companies, our governmental and non-governmental agencies, acronyms abound. And let's be honest, we love them. At Vaisala we each have our own derived from our first and last names. I am JABE, from Janice Bennett. It doesn't really match my name since I married, but, I'm still JABE. When someone calls me JABE, I know it's a colleague and we can easily speak in acronyms and understand each other, e.g.: "What's the ETA on the LSC FAQ for IT?" Another example, our Senior CMS product manager is JALD. JALD rhymes with BALD, which he is... mostly. (We don't think the assigners of acronyms did that on purpose, but...one never knows. Surely then Paul Daniel should be PALD. We cannot be certain. Note that my acronym just happens to rhyme with BABE.) People use acronyms because they allow us to fit a lot of meaning into very few letters. They also demarcate a discourse community, making us feel like insiders. HOWEVER, it's not unknown to mix up one's acronyms, or even (dare we admit) have a somewhat fuzzy understanding of the acronyms we are surrounded by. Plus, in a global economy, we often have to understand acronyms from multiple regions. The letters may be from a different language than English, making it tough to remember for the mono-linguistic among us. (Bonus Pop Quiz: What is BIPM?) How to Use GAMP to Validate a Continuous Monitoring System Infographic3.57 MB
European Medicines Agency This glossary gives definitions for the main regulatory terms used on this website and in European Medicines Agency (EMA) documents. Glossary
This week, Paul Daniel comes to the rescue! In his most endearingly pedantic way, Paul gives us a quick OV (that is: overview) of some acronyms and terms that are crucial for those in life science industries: Paul writes: GAMP = Good Automated Manufacturing Practice. This is not just another version of GMP, or GxP, etc. GAMP is a trademarked acronym of the ISPE – International Society of Pharmaceutical Engineers. There is a lot of stuff in this large and dense body of work. The part we know best (because of what we offer) is the recommended practices for the management of the life cycle of an automated system, including validation/qualification. Since we at provide systems to those who manufacture pharmaceuticals, we must understand what's required. Our most heavily regulated customers prefer to implement our CMS along these lines. Our goal, I think, is to help them do this by having a well-designed system. For in-depth information on GAMP as it applies to our systems, we have an infographic describing GAMP guidelines for installation/validation (see below) as well as an eBook outlining GAMP applied to system selection and validation. GxP = Good (Insert Term) Practice. Simply insert your industry's function, I.E.: Manufacturing, Documentation, Distribution, Clinical Data Management. Find a list here. Note that it's Good Practice - not Best Practice. The term "Best Practice" has fallen out of use lately, especially with Quality concerned folk, simply because of the principle of seeking continuous improvement. If something is 'best' it can never be improved upon, but technology changes and industry standards change to embrace innovation. Mike Myatt has a fun article on this topic "Best Practices... Aren't" in Forbes magazine. CFR 21 = The Code of Federal Regulations in the US. It is a collection of "administrative laws" made by organizations that have been empowered by Congress. In this case, the FDA was created and given authority by the legislature. The FDA, with this authority, created several the regulations in Title 21 which apply to Food and Drugs. Part 11 = 21 CFR Part 11. This governs Electronic Records and Electronic Signatures when used in the production of Food and Drugs. Find the entire thing here.
GAMP = Good Automated Manufacturing Practice. This is not just another version of GMP, or GxP, etc. GAMP is a trademarked acronym of the ISPE – International Society of Pharmaceutical Engineers. There is a lot of stuff in this large and dense body of work. The part we know best (because of what we offer) is the recommended practices for the management of the life cycle of an automated system, including validation/qualification. Since we at provide systems to those who manufacture pharmaceuticals, we must understand what's required. Our most heavily regulated customers prefer to implement our CMS along these lines. Our goal, I think, is to help them do this by having a well-designed system. For in-depth information on GAMP as it applies to our systems, we have an infographic describing GAMP guidelines for installation/validation (see below) as well as an eBook outlining GAMP applied to system selection and validation.
GxP = Good (Insert Term) Practice. Simply insert your industry's function, I.E.: Manufacturing, Documentation, Distribution, Clinical Data Management. Find a list here. Note that it's Good Practice - not Best Practice. The term "Best Practice" has fallen out of use lately, especially with Quality concerned folk, simply because of the principle of seeking continuous improvement. If something is 'best' it can never be improved upon, but technology changes and industry standards change to embrace innovation. Mike Myatt has a fun article on this topic "Best Practices... Aren't" in Forbes magazine.
CFR 21 = The Code of Federal Regulations in the US. It is a collection of "administrative laws" made by organizations that have been empowered by Congress. In this case, the FDA was created and given authority by the legislature. The FDA, with this authority, created several the regulations in Title 21 which apply to Food and Drugs.
Part 11 = 21 CFR Part 11. This governs Electronic Records and Electronic Signatures when used in the production of Food and Drugs. Find the entire thing here.
Contributors Paul Daniel, Vaisala Senior GxP Regulatory Compliance Expert Paul Daniel has worked in the GMP-regulated industries for over 25 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems. At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications. Paul is a graduate of University of California, Berkeley, with a bachelor’s degree in biology. Connect on LinkedIn Janice Bennett-Livingston Marketing Manager Email [email protected] In addition to editing the Vaisala Life Science blog, Janice Bennett-Livingston is the Global Life Science Marketing Manager for Vaisala's Industrial Measurements business area. Pre-Vaisala writing credits include a monthly column called "Research Watch" for Canada's award-winning magazine alive, as well as articles in Canadian Living and other periodicals. Other past work: copywriting for DDB Canada, technical writing at Business Objects, and communications specialist for the British Columbia Child & Family Research Institute.
Paul Daniel, Vaisala Senior GxP Regulatory Compliance Expert Paul Daniel has worked in the GMP-regulated industries for over 25 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems. At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications. Paul is a graduate of University of California, Berkeley, with a bachelor’s degree in biology. Connect on LinkedIn
Janice Bennett-Livingston Marketing Manager Email [email protected] In addition to editing the Vaisala Life Science blog, Janice Bennett-Livingston is the Global Life Science Marketing Manager for Vaisala's Industrial Measurements business area. Pre-Vaisala writing credits include a monthly column called "Research Watch" for Canada's award-winning magazine alive, as well as articles in Canadian Living and other periodicals. Other past work: copywriting for DDB Canada, technical writing at Business Objects, and communications specialist for the British Columbia Child & Family Research Institute.
