Quality & Compliance
Navigating EU GMP Compliance: A Consultant's Guide to Smooth Sailing
Hello, fellow pharma enthusiasts! In the fast-paced world of pharmaceuticals, ensuring Good Manufacturing Practice (GMP) compliance is essential to maintaining product quality and safety. The...
Quality & Compliance
Staying GMP Compliant: A Consultant's Guide to Compliance Bliss
Hello, dear readers and fellow compliance enthusiasts! Welcome to our journey through the labyrinth of Good Manufacturing Practices (GMP) compliance. As a consulting company that provides audit...
Clinical Research Solutions
7 Critical Factors for Successful Selection of CDMO for Cell and Gene Therapy Manufacturing
Developing, optimising, and manufacturing Advanced Therapy Medicinal Products (ATMP's), such as Cell and Gene Therapy (CAGT) products is extremely complex. The choice of a reliable Contract...
Clinical Research Solutions
Prepare for Your Next Audit: A 5-Point GMP Checklist
Ensuring you have full control over your processes, facility, and quality management system (QMS), and ultimately your final product quality, is a demanding and important task. An inability to do so...
Clinical Research Solutions
Why the FDA Should Never Be Your First Inspection
You can expect several FDA audits throughout your drug development program The Agency’s goal is to protect the public from unsafe products, and one of the best ways to accomplish that goal is by...
Clinical Research Solutions
Outsourcing Functions Doesn't Mean You've Outsourced Compliance Obligations
Over the past 20 years, the traditional approach to drug development has expanded to include the outsourcing of a range of testing and manufacturing functions. As a part of their long-term strategic...
Clinical Research Solutions
Industry Poll: How Can Your GMP Auditing Program Be Most Improved
Recently, ProPharma conducted a poll to quality professionals across the country to understand the challenges that FDA regulated companies face in managing their GMP auditing programs. As depicted in...
Clinical Research Solutions
Industry Poll: What are the Leading Challenges with GMP Auditing?
In a recent poll conducted by ProPharma Group, the question “What is your biggest GMP auditing challenge?” was posed to Quality professionals in the drug manufacturing industry. The following graph...
Clinical Research Solutions
FDA Announces Voluntary Recall of Drugs Containing Valsartan
On Friday, July 13th, FDA announced the voluntary recall of several drugs containing the active ingredient valsartan. Valsartan is often used to treat serious medical conditions such as high blood...
Clinical Research Solutions
FDA Takes Steps to Improve Efficiency of Global Pharmaceutical Manufacturing Inspections
On Tuesday, October 31st, the FDA announced that it will begin allowing eight European drug regulatory authorities to conduct inspections of manufacturing facilities and determine whether or not they...