What is the Common Technical Document (CTD)? The Common Technical Document (CTD) format or dossier was designed by the ICH and was agreed upon as a common format between three major regulatory regions, i.e. European Union (EU), USA, and Japan for submission of...
News & Blog
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 and how to avoid or prevent them. In the United States of America, pharmaceutical drugs and medical devices are controlled according to The...
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 learn about inspection and audit best practices in our series of blogs on inspection management. The Importance of First Impressions on Inspection Day Did...
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 sure,” then it is time to get prepared and begin conducting some internal audits. What exactly is an internal audit? Internal audits evaluate the company’s...
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 administered by intravenous injection to immunocompromised patients and during critical care...
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 the concepts introduced in the first two installments: QRM in C&Q Planning, and Risk Assessments – One Size Does Not Fit All. This week’s...
Risk Assessment Methods – One Size Does Not Fit All
Risk assessment is a key competency for modern Pharma/Biopharma organizations. Since the publication of ICH Q9 “Quality Risk Management” in 2005, the use of both formal and informal risk assessment tools has become a critical activity and a focus of regulatory...
Reviewing Documents 101
When it comes to reviewing documents such as batch records, qualifications, validations, and other important documents, there are certain items that should be reviewed carefully. The reviewing of documents is a very important task within a company. Let’s take a...
Quality 101 for Cannabis Products
Quality is the driving factor that keeps our food system safe. In the United States, there is an unspoken trust put into our food system to keep it safe. How does this safety happen? There are systems and procedures that maintain the integrity of the products consumed...
Wrapping Up the Inspection
This series on inspection success has stressed the importance of making a good first impression, preparing your inspection management team, using inspection management software, who to have available during an inspection, and how to fulfill the inspector’s requests....