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...
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...
The Transfer Process Map: Gate Four in the Nine Gate Transfer Process for Moving Production
If you have been following along, you now know that I have reviewed the first three gates to the Nine Gate Transfer Process for moving production from site to site. I have covered: Gate 1: Assessment...
What is the Future for Pharmaceutical Compounding Companies?
The Food and Drug Administration (FDA) may soon be cracking down on compounding pharmacies according to a recent bill introduced in the United States Legislature. The bill (Drug Quality and Security...
Critical Elements of Knowledge Management in a Pharmaceutical Quality System
The concepts detailed in ICH Q10, Pharmaceutical Quality Systems (PQS) are commonly understood and are progressively being employed in modern quality management systems. The intent of the PQS...
The Transfer Plan: Gate Three in the Nine Gate Transfer Process
Today I would like to present the third entry in the series discussing the Nine Gate Transfer Process for moving production from site to site: the Gate 3 Transfer Plan. In case you missed them, you...
Why Measure and Report Quality Metrics?
A wise man recently told me that “honor and respect should be given freely, but trust is earned”. Whether it’s in politics, friendships, church, marriages, parenting or even the business world,...
Stakeholder Review: Gate Two in The Nine Gate Transfer Process for Moving Production
In this, the second entry in the series, I will review Gate 2 of the Nine Gate Transfer Process utilized by ProPharma Group for successful technical transfers. Refer to my first entry for further...
OIG Signals Importance of Board-Level Compliance Committee in J&J Corporate Integrity Agreement
In the just issued Johnson & Johnson Corporate Integrity Agreement (CIA), the Office of Inspector General (OIG) has, for the second time in less than a year, required that a company maintain a...
The Nine Gate Transfer Process for Moving Production from Site to Site: Gate 1
Pharmaceutical news today featured another article about a manufacturing plant closure and the layoff of a thousand employees. Demand for pharmaceutical products continues to grow and will continue...
Government Aims its Sights on Smaller Pharmaceutical Companies
Big pharma and their deep pockets have been the focus of enforcement activities for a number of years but in 2013 that tide may be turning. In the past few months, settlements with ISTA...
Do Not Neglect GMP in your Serialization Project
In what for some may be a relatively chaotic run-up to meeting California’s 2015 serialization regulation, it is critical for serialization project managers to assure implementation falls within the...
Three Solutions to Typical Autoclave Temperature Mapping Conundrums
Temperature Mapping is an intrinsic part of equipment validation. It evaluates the quality and compliant nature of the equipment to ensure the equipment meets the user and regulatory agency’s...
Understanding Statistical Intervals: Part 2 - Prediction Intervals
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...
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...
Lean CSV – How to Reduce Waste and Increase Value
What is lean? Lean is a business system focused on continuously improving processes by reducing the time taken and the waste involved in delivering increasing value to the customer. Customers in this...