Compliance Perspectives: Articles from our Blog

Recent Posts:

"Getting the Most from Your GMP Supplier Audit" (6/10/2019)
Whether you're pre-qualifying a CDMO or conducting a routine audit of one of your manufacturing partners, your time on site is limited. Here's how to get the most out of it.



"When Sites, eSystems, and Inspections Meet"  (3/11/2019)
Sponsors and CROs – here’s how you can help your sites answer inspection questions about the computer systems you provide.



"FDA Puts Santa on the Naughty List"  (12/9/2018)
FDA finds deficiencies in Enterprise Labor Force (ELF) training at North Pole facility, as well as, distribution, warehousing, and quality control violations. (Spoiler alert: Frosty doesn’t fare so well.)


"The One-Hour Study Site Audit"  (10/15/2018)
Question: What if you only had 1 hour to conduct a site audit? What would you look at? The question is absurd, of course, but the answers our auditors gave are illuminating.



"What Surprises GCP Auditors the Most?"  (8/13/2018)
Last month, I asked some of our most experienced GCP compliance auditors what surprised them about the audits they conduct. You could say that I was the one that was surprised by their responses.



"eSource Terminology Untangled"  (5/14/2018)
If you’re ever talking about eSource and things start going sideways, you and your colleagues may not be using the same working definition. Though FDA has formally defined the term “eSource” for clinical investigations, casual use often leads to conversational cross talk. Here we offer a short, easy-to-follow interpretation, provide multiple examples, and remedy some of the more common confusions we hear.


"Delegation of Authority: Tips for Monitors"  (3/19/2018)
Why do regulators care so much about Delegation of Authority logs? Because they provide evidence that study tasks have been assigned only to staff members qualified to carry them out. By reviewing DoA logs, monitors can help their sites comply with the new ICH E6(R2) requirements for PI supervision and staff qualifications.

"Study Sites: Show 'Em Your QC"  (1/15/2018)
Sponsors and CROs want to know that quality management at your site is a continual process. Don't have formal QC procedures in place? You can start by controlling and guarding against these usual suspects.


"Love at First Site: How to Spot Strong PI Oversight"  (11/13/2017)
As Sponsors and CROs, you're sometimes forced to make site selection decisions based on a limited set of criteria that you deem to be -- hope to be -- reflective of the site as a whole. On what should your pre-study visit focus to help you gauge the level of oversight you can expect from a prospective PI?


"Anticipating Tensions Between Clinical Care and Study Protocol" (9/19/2017)
Protocol trumps practice. This principle seems clear enough, but complying with it is not always as straight-forward as it sounds.



"Coping with Scoping Your CSV/Part 11 Audit" (7/18/2017)
You don’t spend your day thinking about where your system components are located, how your vendor combines software and services, or what Part 11 requirements apply to your application. Your expertise is in manufacturing. Or clinical research. Or lab operations. Yet somehow it’s your job to make sure an effective and properly-sized system audit is conducted. Here’s what you need to discuss with QA.


"Notes 2 Fix Your Notes 2 File" (5/22/2017)
Q: If Notes to File can be red flags to regulatory inspectors, should I quit
using them?
A: No. But here's what you need to do...
(Your future self will thank you for a well-written NTF today.)



“When GMP and GCP Meet“ (4/4/2017)
What should happen when a drug lot in a clinical trial fails GMP stability testing? Because some IP manufacturing processes are conducted concurrently with clinical studies, GMP procedures can affect the GCP activities that site staff perform.



“Site Selection: Don't Forget About the Study Drug“ (2/6/2017)

During the site selection process, Sponsors/CROs need to verify that their prospective sites are able to store, prepare, and administer their particular study drug. Here are some considerations to watch out for.

 


“When is a Customer NOT a Customer?“ (12/4/2016) 

While patients and students both consume services, neither can be considered a customer in the traditional sense. What do these communities have in common and what does it mean for the professionals and institutions who serve them?

“Avoiding Protocol Deviations” (10/11/2016) 

According to 2015 FDA statistics, the most frequently cited violation in clinical research by far was “failure to conduct research in accordance with the investigational plan.” Do you know this finding also topped the list the year before that? And the year before that? In fact, deviating from the protocol has been the most common observation EVERY YEAR for the last decade.

Why does this keep happening?

 

 

“Optimizing Outsourcing Options for Small Sponsors” (9/6/2016)

Strategic partnerships between large Sponsors and CROs can make it difficult for smaller sponsors to receive the quality of service and level of commitment they’re looking for. What can smaller pharmaceutical companies do to secure the outsourcing resources they require?

 

 

“FDA Site Inspections: 5 Tips for Success” (8/2/2016)

Anxiety over regulatory inspections often stems from the feeling that you lack control, but it doesn’t have to be that way. There are many steps you can take -- before, during, and even after an inspection is over -- that can give you a fair degree of control over the outcome of your FDA inspection.



“Movie Quotes for QA Professionals” (4/25/2016)

Qualification records are amiss at Casablanca Therapeutics.
*And amiss is still amiss*  (Sorry.)

Q: What happens when you mix Hollywood with QA?
A: Nerd humor

 

 

“SOP Revision, SWAT-Style” (3/22/2016)

SOP revision -- now there’s a popular topic. It falls somewhere on the likability scale between income tax prep and colonoscopy prep. So why would you want to read about it? Maybe you’re hoping someone’s figured out a way to make the process more efficient and less painful. Maybe we have.

 

 

“Study Sites: Too Many Vendors, Too Little Time” (2/3/2016)

There’s more technology in clinical research than ever before and more niche vendors to supply it. Some study sites have become de facto Vendor Management departments which burdens their staff and leaves Sponsor/CROs in the dark. Here’s our solution.

 

 

“Q&A: SOPs for Research Sites” (10/20/2015)

What kind of written site procedures are required?  Do they need to be controlled documents?  How do auditors approach site SOPs and work instructions during an audit?  Are there recognized best practices?  Responses to these questions came from sites, sponsors, CROs, and QA consultants.  We've summarized the discussion and added a bit of our own perspective.

 

 

“Big Changes for ICH GCP and EU Regulations” (9/8/2015)

A new addendum to ICH E6 drafts the most substantial change to international research guidelines in 20 years.  At about the same time, a new Clinical Trial Regulation will replace the current, decade-old Directive.  What changes are being proposed for international research? How and when will they affect you?

 

 

“The CAPA Detective” (7/20/2015)
Every industry has its detectives. Mechanics and journalists hunt for leaks. Software testers and security experts look for bugs. Meteorologists, defense strategists, and forensic accountants all look for trouble brewing off shore. (The level of intrigue may vary.) In the GMP world, it’s the CAPA investigator who serves as detective, identifying how and why manufacturing defects occur. Follow along as our CAPA detective tracks down the root cause of a consumer complaint.

“Remote SDV/SDR: Alternatives to Redact/Fax” (4/21/2015)
Some remote source data review techniques are very labor-intensive for the study site. They don’t have to be.

 

"How To Tip Off a GCP Auditor in 25 Words or Less" (3/3/2015)
“What tipped you off?” “How did you know to look there?”
Our GCP trainers frequently hear those questions from class attendees. Sometimes the tip-off is something very subtle that requires the keen eye of an experienced auditor to notice. And other times, not so much.

"Regulatory Tools go UFO: Useful, Free & Online" (1/27/2015)
The first blog post of 2015 introduces you to 5 free, online regulatory tools you might find useful. Bonus: 3 of the tools are in a beta or early release; their developers are encouraging feedback, so you have an opportunity to suggest features or content that may increase their usefulness to you.

"What Does Risk-based Monitoring Mean for QA Auditing?" (12/9/2014)
By now, we all know that risk-based monitoring isn’t just about changing the role of the CRA; it’s transforming the way clinical studies are managed. So what does that mean for QA teams who audit these new processes? Will QA auditing be used to evaluate the effectiveness of RBM plans? In its final RBM guidance, FDA suggests yes. How else will RBM affect GCP auditing?

"Anatomy of a GMP Vendor Qualification Program" (9/21/2014)
Pharmaceutical companies are only as compliant as their vendors. In a contract manufacturing arrangement, the manufacturer is held responsible for any cGMP deficiencies; however, you, as the sponsor or CRO, would be held responsible for your lack of vendor oversight. That’s why a robust vendor qualification program is so critical.