Structure of the Common Technical Document (CTD)- M4 Guideline
What is the Common Technical Document (CTD)? The Common Technical Document (CTD) format or dossier was designed by the ICH and…
Inspections and Audits: What You Need to Know
Are you worried about an inspection from the FDA, MHRA, or another global regulatory agency? Use the anxiety and…
Internal Audits: Improving Companies One Department at a Time
Is your company ready for an inspector to audit your departments? If you’re thinking to yourself, “I’m not too…
Top 2 FDA Citations to Avoid
The consequences of FDA citations can be costly. In this blog article, we discuss the top two FDA citations for pharmaceuticals…
The Importance of New Perspectives in Continuous Improvement
My career in the BioScience/Pharmaceutical/Healthcare industry started at a company that manufactured blood plasma-derived therapies. These life-saving treatments were…
Critical Aspects of Pharmaceutical Facilities and Equipment – Identification and Verification
This is the third in PSC’s series on Quality Risk Management (QRM) in Commissioning and Qualification (C&Q) following on…
