Quality & Compliance
Mergers, Acquisitions and Consolidations: Whose Validation Standards Do I Use?
If you are like the majority of those who have worked in the biotechnology and pharmaceutical industry for at least the last five years, your company has been part of a merger, acquisition or some...
Learn Your Lessons Well: How Regulatory Strategies and Clinical Trial Design Affect Approvability
A recent analysis by the Tufts Center for the Study of Drug Development places the price tag of bringing a new drug to market at around $2.6 billion. The reason for this is simple: failure. Drugs...
Why Are My Swab Recoveries So Low?
Cleaning Validation and GMP reviews of those protocols are challenging. They become even more challenging at a Contract Manufacturing Organization (CMO) where compliance assessments to in-house...
Quality & Compliance
Continued Cleaning Effectiveness: What Are You Doing? - Part II
My last blog focused on the industry trends concerning cleaning validation verification. Through a quick poll we found that out of twenty-three respondents, approximately fifty (50) percent are doing...
Quality & Compliance
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...
FDA Updates Informed Consent Guidance
FDA recently updated its informed consent guidance in the form of an Information Sheet. The new document reflects the Agency’s current thinking on the informed consent process utilized in...
Quality & Compliance
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...
Quality & Compliance
The Cost of Inadequately Scheduling Cleaning Validation
Ever wonder why some—most—projects don’t go as planned? Let me take a chance at explaining what I have observed in the last few decades. Firstly, let us assume that you have contracted a well-known...
Quality & Compliance
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....
Quality & Compliance
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...
Quality & Compliance
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...
Quality & Compliance
Evaluating the Effectiveness of a Corporate Compliance Program: How Does Your Program Measure Up?
At the recent Pharmaceutical Compliance Congress (PCC), Zane Memeger, U.S. Attorney for the Eastern District of Pennsylvania stated that one of the key questions that a company should ask about its...
Ready for cGMP Validation: Gate Seven of the Nine Gate Transfer Process
Today, Bob Beall is back with the next gate in the Nine Gate Transfer Process. If you have missed any of the previous steps in this process, you can review them here: Gate 1: Assessment Gate 2:...
Formulation and Process Development: Gate 6 of the Nine Gate Transfer Process for Moving Production
Today, we are continuing our blog series on the Nine Gate Transfer Process for Moving Production from Site to Site, with Gate 6: Formulation and Process Development. If you have missed any previous...
FDA Revisits the Topic of INDs for Dietary Supplements
One of the fundamental disconnects in the dietary supplement world is that despite the fact that manufacturers of dietary supplements are not allowed to make claims regarding effects on diseases,...
Quality & Compliance
What’s the Skinny on Dietary Supplements?
One doesn't have to spend much time in a pharmacy, grocery store or even a typical American house to see that dietary supplements have found a place in people's lives. In fact, roughly 54% of U.S....