GxP Perspectives

Just what is “GxP?” Do people in FDA regulated industry need training? And just why do you call the Blog, “GxP Perspectives?” These are good questions and we have a Guest Commentary from Nancie Celini, a GxP training specialist, to help answer the first two. She has written a 2-part introduction to GxP training for the Blog. I will put up the next part in a week after, hopefully, doing some on the scene blogging at the DIA Annual Meeting in Washington DC. As far as question #3 about why I call the Blog “GxP Perspectives?” I’m not sure, I just didn’t want to just be writing about “stuff.” So now, Here’s Nancie.

GUEST COMMENTARY

Part 1 of 2 Parts:

Defining GxP Training / Learning

By Nancie Celini
June 8, 2010

The bio/pharmaceutical industry has created its own language and GxP is one of many acronyms that we all tend to use. While this may seem “elementary” to some of you, many people may not know what this means. So let’s define it because when we refer to “GxP training” you need to have the right context.

G = Good
x (variable replaced with Clinical, Manufacturing or Laboratory)
P = Practice

As you can see, GxP is used as short-hand form for referring to the regulations established by the United States Food and Drug Administration which are published in the Code of Federal Regulations. Sometimes people refer to the “GCPs” which specifically regards the rules that govern clinical trials vs. product manufacturing (GMPs) or laboratory regulations (GLPs). Together, these are known collectively as the “predicate rules” that govern a wide spectrum of regulatory obligations across this diverse industry. This is also where citations emanate from (typically) as regards FDA inspections. Violation of a predicate rule will most likely result in a 483 followed by a warning letter. Get it? There is just a bit more to help you navigate this important terrain before we delve into why a GxP training / learning program is vital.

When a regulation is cited, the title tells you where it is published. For example: 21 CFR 312.2 means:
21 = Title 21
CFR = Code of Federal Regulations
312.2 (312 = part and 2 =section)

There is a helpful website to quickly find and research the regulations. As an educator in our industry and academia I strongly suggest you read the ones that pertain to your role and specific area even if you have read them before. It is important to stay current! Using this site you can search by the actual regulation or key words. Go to:

http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm

Remember that federal regulations are laws and they establish the obligations that sponsor organizations, investigators and IRBs/IECs (institutional review boards and independent ethics committees) must be compliant with. This includes the requirement to engage personnel who are effectively trained by way of education and / or prior experience and on-going training. An example from the CFR;

21 CFR 312.53 Selecting investigators and monitors.
 (a) Selecting investigators. A sponsor shall select only investigators qualified by training and experience as appropriate experts to investigate the drug.
Ibid.
 Viii. (2) Curriculum vitae. A curriculum vitae or other statement of qualifications of the investigator showing the education, training, and experience that qualifies the investigator as an expert in the clinical investigation of the drug for the use under investigation.

If you are responsible for a “GxP” task, it is an easy way to say you are performing a regulated process that is most likely linked to a predicate rule or guidance and should be covered by policy and / or specific documented procedures (a.k.a. SOPs) that you are trained in. Some examples include development of a protocol or monitoring a clinical study. These are the types of topics that should be covered when designing a “GxP learning program” as well as procedures and yearly refresher programs. The more diverse your organization, the broader your program(s) should be for enabling personnel to learn what they need to in deference to the professional backgrounds they brought with them when they were hired. Programs today must be more robust than ever to accommodate all the topics we are all challenged to be knowledgeable in. A brief yearly refresher alone is often not enough.

In the next article I will discuss why a comprehensive learning strategy and program must be in place if today’s bio/pharmaceutical organizations are compliant with the regulations and poised for change and transformation. Peter Senge said it best when he described learning organizations as:

“…organizations where people continually expand their capacity to create the results they truly desire, where new and expansive patterns of thinking are nurtured, where collective aspiration is set free, and where people are continually learning to see the whole together.”

Seeing the “whole” as regards GxP is imperative and will keep your organization on track with existing rules as well as emerging ones. After all, we find ourselves in industry during interesting times of global trials with virtual reach as well as economic and healthcare reform. Do you know what the implications of the current reform legislation are regarding the bio/pharmaceutical industry? That is something for homework. We all need to be ready to transform and respond nimbly to the changes that are coming.

There is more to come in the next article but if you haven’t read Senge’s book I highly recommend you do especially if GxP training is your responsibility. Senge’s work is timeless as we prepare for the challenges and excitement of a new road ahead.

Good luck and good learning!

Read Part Two of Nancie’s training article

Save The Date: On 4-5 November 2010 the Pacific Regional Chapter of the Society for Quality Assurance (PRCSQA) and the Organization of Regulatory and Clinical Associates (ORCA), a Pacific Northwest based organization, will co-sponsor a Fall Training on regulatory compliance topics in Seattle, WA.

The PRCSQA LinkedIn Group will update the agenda for the training. PRCSQA Fall Training workshops have traditionally been “at cost” and are an affordable training opportunity. The sessions will cover both GCPs and GLPs with speakers lined up on vendor management, quality systems, and GLP updates.

GxP Perspectives LinkedIn Group

This entry was posted on Friday, June 11th, 2010 at 4:21 PM and is filed under Commentaries by Guest Writers. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.