What's Coming Up in NCSLI's Recommended Practice 6... An Update from this year's Symposium
Vaisala is part of the NCSLI's Healthcare Metrology Committee and attended the committee discussions at this year's Workshop & Symposium in Lake Buena Vista, FL.
In this week's blog, Janice Bennett-Livingston interviews our calibration manager on the progress of an update the committee is currently working on:
"Recommended Practice 6 - Calibration Control Systems for the Biomedical and Pharmaceutical Industry."
|Janice||Calibration Manager Mike|
|So, how was NCSLI this year? Hot enough for you in Florida in July?||I thought we were going to talk about RP 6. Stop wasting my time. ;)|
|Fair enough! I did say this interview would cost you 15 or 20 minutes…||You lie.|
|This is true. So… What is RP 6?||
First off, RP 6 is not a prescriptive or regulatory document; the RP stands for "Recommended Practice." These practices are identified and described by professionals from NIST, drug, device and biotech companies, as well as technology suppliers. The recommendations are based on input from multiple disciplines with the goal of creating an agreed-upon understanding of how to align current practice with current regulatory expectations.
Essentially RP 6 was created to give a new lab manager in a life science company a description of how to run a calibration lab effectively. The document marries metrology with global regulations for GxP from the FDA and EC.
The original need for RP 6 came from the fact that many regulations have a different focus from metrology knowledge areas and practice. For instance, regulations are written from a legal and risk management standpoint that does not always match up easily to the science and technology behind calibration. RP 6 bridges the gap between what the regulations call for, and what metrology practice is.
|Can that new lab manager use RP 6 as a reference?||Definitely. It can be used as justification to an auditor because RP 6 clarifies recommended practices that are vetted by stakeholders in GxP-regulated industries from Europe, Canada, United States and Mexico.|
|Why is RP 6 being revised?||The committee decided to update RP 6 after a survey in 2013 to determine if any areas in RP 6 (2008) that needed more detail and clarification. There were, and those sections are clarified and expanded in this revision to be finalized and released next year.|
|Were there any points of contention on this revision?||Interestingly, there is some disagreement across industries on certain terms. Language is important when you are creating a document that is meant to clarify other documents, such as regulations or guidance. At the last meeting in July, we spent a great deal of time talking about the meaning of the word "tolerance," especially in how it relates to uncertainty. Depending on what industry you come from, there can be different connotations in a word. Metrologists will refer to "The International Vocabulary of Metrology & Related Standards" (VIM), but industrial manufacturers of drugs or devices can have their own understanding of a word like "tolerance" that can account for some subtle differences in understanding.|
|How is this resolved in writing and editing RP 6?||The tough part is defining words in such a way that they align with documents from all stakeholders: regulations from multiple regions, guidance documents from professional organizations like ISPE, and standards from non-regulatory governmental agencies like NIST. I edited the section on Traceability, which was revised in order to clarify what meaning. We wanted to be absolutely unambiguous so that it would clearly define when something is considered traceable, and how you go about proving traceability. I think it's much clearer now.|
|What are other sections of RP 6 changing in this revision?||We are looking closely at systems qualification, vendor selection, and the differences and significance of process tolerance vs instrument tolerance. It's been in the writing stage since 2013, and we are now editing and reviewing all the written sections. The goal is to have it ready for approval by NCSL Workshop & Symposium 2015 and released within the calendar year.|
|As Vaisala's Calibration Development Manager for Life Science systems, how is RP 6 important to you?||As a calibration provider, Vaisala has to know what life science customers need from us in device capabilities and calibration. RP 6 bridges the regulations and metrology. Understanding this allows Vaisala to win business from GxP-regulated customers, and then help keep those customers compliant, competitive, and cost efficient.|
|Three C's… well played sir.||I should be writing clever blogs...|