News/Events

PDA NE Dinner Meeting – Visit Us!

ICQ Consultants, Michael Gatta and Peter Broomes will be attending tonight’s PDA New England Dinner Meeting & Berkshire Facility Tour.  Please make sure to stop and say hello to them if you are there!  The link below will provide the events agenda and description. PDA NE – NE Dinner Meeting

Different Ways to Fasten Biological Indicators (BI)

Introduction to BIs Biological indicators (BIs), as defined by ANSI/AAMI and ISO, are test systems containing viable microorganisms providing a defined resistance to a specific sterilization process. A biological indicator provides information on whether necessary conditions were met to kill a specified number of microorganisms for a given sterilization process, providing a level of confidence in […]

Project Schedules: How to Help Yourself and the Project Scheduler

Lack of experience with project scheduling by project team members is one of the biggest frustrations that a project manager/project scheduler faces.  Projects in a matrix organization are often staffed with team members who are not familiar with project schedules.  The team members provide input on tasks that they will need to perform to complete […]

Mods and Pods in BioPharm

Flexible Manufacturing: Mods and Pods in BioPharm Early facility design and BioPharm beginnings Ever since I was a child, I have loved to build.  Like many kids of my generation, I grew up playing with Legos, Tinker Toys and Erector Sets.  These objects would fill my days, providing hours of entertainment.  The best part about […]

Temperature Controlled Systems: Refrigerators and Freezers

Have you ever completed the temperature mapping / qualification testing for a walk-in refrigerator or freezer and felt good about the data? That is until someone asked you to relate what the numbers mean in relation to the system and what was happening inside the unit. You knew the results met the acceptance criteria, but […]

Peter Broomes Joins ICQ as North East Regional Director

Peter Broomes, an accomplished operations manager, process engineer and project engineer with over seventeen years of experience in the biopharmaceutical sector, has joined Integrated Commissioning & Qualification Corp. (ICQ) as its North East Regional Director. In this new senior management position, Peter will oversee ICQ client relationships, resource deployment, team recruitment and business development efforts […]

Industry 4.0 and the Manufacturing Facilities of Tomorrow

On May 16, I attended the ISPE event Pharma 4.0: The Next Industrial Revolution in Manufacturing for Automation, Controls, and Decision Making. Technology is advancing at an ever-increasing pace, and it can be difficult to keep up with the newest innovations. One of the major advances in recent years is called the Internet of Things, or IoT. IoT […]

Hiring: Raleigh – Durham Area, CQV Professionals

ICQ is currently hiring for multiple openings in the Greater Raleigh Area.  If you or anyone you know may be interested, please apply here or email a copy of your resume to resumes@icqconsultants.com.  

Validation 101: System Requirements

Why are requirements and specifications needed in validation? Validation is testing a system to standards or acceptable criteria. If your own requirements are not in place, then you will end up validating a system to someone else’s standards. There are thousands of features and conditions to consider and considering them beforehand allows your company to […]

ICQ Consultants is Re-Branding

We are very excited to announce the launch of our newly designed website.  The new interactive website has a bold, clean look as does our new ICQ logo. Our more user-friendly website interface and homepage layout provides current and prospective clients with useful information about our services and our company.  For our prospective future employees, our new […]

Principles of Quality-by-Design in Pharmaceutical Development

The Key Concept: The Quality-by-Design (QbD) concept is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management [ICH Q8 (R2)]. A key assertion of QbD is that quality is controlled not by simply testing the product, but […]

GMP and Product Development Phases

Thousands of biotech pharma companies are conducting excellent research for the development of novel medicines for existing and unmet needs. According to clinicaltrails.gov, there are at this time more than 115,000 clinical trials being conducted in the US alone with around 22,000 studies in pre or clinical phase 1, 29,000 in clinical phase 2 and […]