Clinical Research Solutions
Outsourcing Facilities and GMP: The Quality Systems Challenge
Compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes,...
Environmental Monitoring: The Top 3 Points to Consider
When a biopharmaceutical company builds new or renovates existing manufacturing space, the last consideration before turning the production key is the environmental monitoring of the same. This short...
Using Propagation of Error to Determine Validation Acceptance Criteria for In-Process Measurements
Many times in validation I am confronted with the problem of how to set acceptance criteria for critical process measurements. This is particularly true of in process measurements made during...
Sneak Preview: What Will the Quality Metrics Initiative Look Like?
I had lunch in a restaurant the other day. During my meal, I noticed that there weren't many other customers. I didn't give it much thought until I walked out and read the restaurant's hygiene grade...
Is social media the next monitoring emphasis for the OIG?
In June 2014, the FDA issued two draft social media guidance documents that may not clearly answer all of the questions that the drug and device industries have about how to use social media to...
The Difference Between Quality and Compliance, Part II
In a blog earlier this month, I mentioned that there are recent initiatives underfoot that FDA hopes will create FDA-industry partnerships, increase transparency, utilize data more effectively, and...
The Difference Between Quality and Compliance
In case you haven’t noticed, FDA is tired of being the “bad guy”. While they do not back-off of their responsibility to enforce the applicable Code of Federal Regulations for a millisecond, their...
GAMP® 5 Concept 2 – System Life Cycle
So far in our series on GAMP 5 we’ve provided a high level overview of the five major GAMP concepts, and a more in depth discussion of Concept 1, Process Knowledge and Understanding. In this...
GAMP® 5 Concept – Process Understanding
In my previous blog I re-visited key GAMP® 5 concepts as they relate to establishing a compliant system validation methodology. My next few blogs will focus on each of these concepts in more detail....
Risk Assessments Mitigate Risk for Bigger and Smaller Companies Alike
Earlier this year, the Officer of Inspector General (OIG) put smaller life sciences companies on notice that they should put in place a risk assessment process as part of their corporate compliance...
Post-Validation: Gate Nine of the Nine Gate Transfer Process
As the pharmaceutical supply chain evolves, at some point product/technology transfers will become part of the improvement process. When transferring production from site to site, an array of complex...
Manage Speaker Program Risk More Effectively with a Needs Assessment
Over the past several years, pharmaceutical company Corporate Integrity Agreements (CIAs) have routinely required needs assessments in connection with the engagement of healthcare professionals...
Clinical Research Solutions
Quality System Professionals: Learn how to Speak “Executive-ese”
It is amazing to me that more C-Level Executives do not perceive their Quality Systems as a powerful vehicle to reduce costs, improve productivity, and benefit their bottom line. Rather than embrace...
GAMP® 5 Basis for Quality System Compliance
Next week I’ll be in San Francisco conducting an ISPE training class on Risk Based Approach to GxP Process Control Systems. Attendees will include employees from a variety of regulated life cycle...
Cleaning Disaster or True Worst Case?
How robust are your cleaning validation measures? Could your storage procedures withstand the impacts of a fire within your facility, or would such a disaster set back your production time...
Improving Computerized System Quality Through Design Verification
Unverified Design – An Example For those of us who travel routinely, one of the most sought-after treasures in the typical airport terminal is an electrical outlet. With our dependency on mobile...