2020 in Review: Reflecting on the Biggest Events & Breakthroughs

2020 has been an unusual year. You could also describe this year as different, difficult, and challenging, just to list a few – the list could go on for days. And yet, this year leaves us with...

Example of an Organizational Maturity Model

Improve Quality Using an Organizational Maturity Model

If this is your first introduction to an Organizational Maturity Model (OMM), you may have a few questions. What is an OMM? What are some common obstacles I might face when implementing an OMM? How...

3 Basic Data Integrity Principles to Protect Value and Drive Success for Cell and Gene Therapy/ATMP Development

Cell and Gene Therapy (CGT)/Advanced Therapy Medicinal Products (ATMPs) have the incredible potential to cure devastating illnesses, such as cancer, on a more personalized level. But, due to the...

Inspector writing down notes at a clean facility.

Clinical Research Solutions

Pre-Approval Inspection (PAI): What it is and How to Prepare

What is a Pre-Approval Inspection (PAI)? A pre-approval inspection (PAI) is performed to provide the Food and Drug Administration (FDA) assurances that a manufacturing site named in a drug...

Quality & Compliance

How Data Integrity Supports a Smooth Transition to Pharma 4.0

The coming pharmaceutical industrial revolution, Pharma 4.0, is an implementation of new systems into the various manufacturing processes leading to an automated production. Introduction of these...

FDA Guidance for Non-COVID-19 Related Clinical Trials During the Pandemic

In March 2020, the FDA published a guidance entitled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency - Guidance for Industry, Investigators, and Institutional...

How Coronavirus Brings Forward New Technologies: The Future of Remote CSV

Is remote Computerized Systems Validation the future standard? Crises are fertile ground for inspiration and creativity resulting in practical new ideas for the near future, as is the case during the...

FDA Emergency Use Authorizations 101: COVID-19 Medical Devices

Everything You Need to Know About Emergency Use Authorizations for Medical Devices to Test and Diagnose COVID-19 In early February, the Secretary of HHS declared that the circumstances presented from...

FDA: CGMP Consultant Recommendation

Reflecting on my interactions with FDA I have come to understand that inspectors do not routinely offer recommendations to firms, when an inspector does provide an opinion it is often prefaced with a...

FDA's Top 483 Observations for 2017: A Reflection of Industry's Compliance

At the beginning of each federal fiscal year, the US FDA posts the previous year’s Form 483 observation metrics issued by each product center. I find that reviewing these metrics provides a valuable...

CPV versus APR, What’s the Difference?

As an outcome of the 2011 Food and Drug Administration Process Validation Guidance, there has been ever increasing interest in the pharmaceutical industry to establish formal Continued Process...

Quick Guide: Coordinating a Laboratory Move

Moving an operational Quality Control Laboratory is all about maintaining the support of production testing, ensuring physical integrity of the instrumentation being moved, and qualification of the...

Are you spending too much on lifecycle costs?

ASTM E2500 – Risk-based testing has been in play for several years now. By design, there is a significant opportunity to avoid many lifecycle costs without creating an adverse impact to quality or...

Clinical Research Solutions

Outsourcing Facilities and GMP: The Validation 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,...

Clinical Research Solutions

Outsourcing Facilities and GMP: A New Relationship

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,...

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...