Clinical Research Solutions
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...
Process Validation: Gate Eight of the Nine Gate Transfer Process
Today we have the next phase of the Nine Gate Transfer Process: Gate 8 Process Validation. To review the previous steps before continuing, examine Gates 1-7 here: Gate 1: Assessment Gate 2:...
Clinical Research Solutions
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...
To Requalify or to Continuously Monitor, That is the Question
Your manufacturing equipment and processes have been established, qualified and validated; all you have to do now is rake in the profits right? Think again, the process of maintaining the validated...
Words, Words, Words: The Importance of Diction in Regulatory Submissions
In continuation of its series of guidances on electronic submissions, FDA recently released a guidance for receipt dates of electronic submissions which emphasizes one important fact: word choice...
Clinical Research Solutions
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....
Clinical Research Solutions
Understanding Statistical Intervals: Part 3 - Tolerance Intervals
We saw in Part 1 of this series how a confidence interval can be calculated to define a range within which the true value of a statistical parameter such as a mean or standard deviation is likely to...
Clinical Research Solutions
The $142 Million Question: Will the Kaiser Judgment Encourage More Private Payor Actions for Off-Label Promotion?
If enforcement against pharmaceutical companies for off-label promotion by the Office of Inspector General (OIG) and the Department of Justice (DOJ) and the Food & Drug Administration (FDA) were not...
Clinical Research Solutions
Personalized Medicine – How Will the Batch Size Change Our Lives?
Hardly a week goes by without the announcement of a new scientific break-through in science and medicine that promises safer, more efficacious and personalized medicine. Where are all these...
Clinical Research Solutions
Understanding Statistical Intervals Part 1 - Confidence Intervals
Statistical intervals are staples of the quality and validation practitioner’s statistical tool box. Statistical intervals can manifest as plus-or-minus limits on test data, represent a margin of...
Why is CAPA so Important Anyway?
Corrective and preventive action (CAPA) can be viewed differently by employees within pharmaceuticals and medical device companies. Some see CAPAs as simply an onerous task given to them to complete...
Critical Process Parameters and Critical Quality Attributes: Why Does the Selection Process Take so Long?
Quick, can you name the top 10 Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) of your bio-pharmaceutical manufacturing process? Well if you hesitated don't feel bad. Most...
Quality & Compliance
Three Key Steps to Conducting a Strong Investigation
Unexpected events often happen in the everyday world. However, in the regulated world great efforts are made to minimize the severity and frequency of unexpected events. Yet, despite best efforts,...
Clinical Research Solutions
Generic Drug User Fee Act (GDUFA) Overview
FDA user fees have been a fact of life for regulated industries for nearly two decades. As you continue to comply by paying the fees, you should understand what the revenue does for you. In this...
Clinical Research Solutions
FDA Comments on Proposed Prescription Drug Labeling
Standardized prescription drug labeling was implemented by FDA in 1979. In the following years as labeling became more complex, FDA re-evaluated its usefulness and published a final rule in 2006...
5 Steps for Developing and Managing Supplier Quality Programs
With the increased pressures of cost control for manufacturers of FDA-regulated products and the rapid expansion of globalization of the supply chain, the expectations of manufacturers and sponsors...