Regulatory Sciences
Understanding EMA and FDA Regulations on Nitrosamine Control
On September 26, 2019, the European Medicines Agency (EMA) released an advice to Marketing Authorization Holders (MAH) of human medicines to review their drug products on possible presence of...
Quality & Compliance
Are Your Compliance Obligations Being Properly Upheld? Avoid This Common Outsourcing Mistake!
Over the past several decades, the traditional approach to drug development and manufacturing has expanded to include the outsourcing of a range of functions from product development and testing, to...
Unlocking Success with Clinical Trial Safety Monitoring During a Pandemic
Earlier this year I wrote to you about US FDA March 2020 issuance of a new guidance for industry, Investigators, and Institutional Review Boards regarding the conduct of clinical trials during the...
Quality & Compliance
Uncover Opportunities for Improvement with an Annual Product Review
The Annual Product Review (APR), also known as the Annual Product Quality Review (APQR), is required for marketed products in an FDA-regulated environment. You may ask, "Why would I want to perform...
Quality & Compliance
EudraLex Volume 4, Annex 1 Update: What You Need to Know
EudraLex Volume 4, Annex 1 provides guidance for the manufacturing of sterile medicinal products that are intended for the European market. It has been updated several times, with the latest revision...
6 Tips to Prepare Your Medical Cannabis Facility for Inspection
You may be considering building a new facility for growing, harvesting, and processing medical cannabis, or perhaps you have an existing facility and want to export to the European Union. What should...
Quality & Compliance
Virtual GCP Auditing: Your Questions Answered!
How quickly the auditing landscape has changed! Less than one year ago if ProPharma were asked to perform a clinical audit on your firm’s behalf, we would reply with "when, what, and where?" Today...
Quality & Compliance
Key Takeaways: New Draft Guidance on Cannabis and Clinical Research
On July 21st, 2020, the FDA released a draft guidance document for developers of cannabis and cannabis derived compounds, aptly titled “Cannabis and Cannabis Derived Compounds: Quality Considerations...
Quality & Compliance
The Key to a Stable Supply of Medicines
The COVID-19 pandemic revealed a structural weakness in many products' supply chains. In terms of supply of pharmaceutical products, supply shocks were not mitigated when intermediates or production...
Quality & Compliance
6 Tips for Evaluating Your CMO’s PAI Readiness
The submission of your drug application (NDA, ANDA, BLA, etc.) is an exciting accomplishment, and one of the first major milestones is a pre-approval inspection (PAI) of the manufacturing sites...
Quality & Compliance
Conducting a PAI Mock Inspection: How to Execute and Evaluate Your Findings
Did you miss our last blog on PAI Readiness? Catch up here to learn what a PAI is and how to prepare. Congratulations! You conducted a Mock Inspection in preparation for your upcoming Pre-Approval...
Quality & Compliance
8 Common QMS Mistakes to Avoid
Previously in part two of this three-part blog series, “Mitigating Compliance Risk with Your Quality Management System,” we discussed how a robust and risk-based Quality Management System (QMS)...
Quality & Compliance
Mitigating Compliance Risk with Your Quality Management System
In the first blog of this three-part series, "Overlooking Your QMS Could Cost You," we discussed the cost of "good" versus "poor" quality, and the importance of investing in a "good" Quality...
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...
Quality & Compliance
Top Tips for a Successful Virtual Audit
The COVID-19 pandemic forced countless companies to change the way they do business in order to continue operating while protecting employees and upholding their social responsibility to the...
Quality & Compliance
Embracing Risk Management Principles: As Easy as One, Two, Three
In the pharmaceutical industry today, there are strict guidelines to adhere to throughout the product lifecycle. Some of them, like risk management, seem more complex and harder to adhere to than...