USP & FDA to Make Critical Updates to Good Storage & Distribution Practices
This blog post will discuss the proposed updates to Good Storage and Distribution Practices from the United States Pharmacopeia (USP) and the Food and
Category
Security & Compliance
Insights and guides filed under Security & Compliance.
Equip Your Drug Launch with Nitrosamine Regulations: Essential Guide
This guide is designed to help organizations understand and comply with the nitrosamine regulations related to marketing applications for new drug pro
Need to Respond to FDA 483s? Here’s What You Need to Know
FDA 483 observations (or "Form 483s") are issued by the Food and Drug Administration (FDA) when findings of a GMP (Good Manufacturing Prac
Discover What GxP Compliance Audits Are & Who Performs Them
GxP independent compliance audits are processes developed to ensure that companies adhere to certain standards of quality, safety, and regulatory comp
Ready for Clinical Trial GCP Audits? Here’s What You Need to Know
A Good Clinical Practice (GCP) audit is an important part of clinical trials that ensures that the methods used and data collected are meeting certain
An In-depth Look at Integrity & Reliability in Bioequivalence Studies
Bioequivalence studies are an important process for ensuring that the pharmaceutical products produced by drug companies meet regulatory standards, su
FDA Announces New Reg. for Easy-to-Understand Medication Info for Patients
When it comes to taking medications, it's important to understand what you're consuming and the possible risks associated with doing so.
Get Ready for the International Recognition Framework (IRF): Understand Your Commitments
The International Recognition Framework (IRF) is an important tool for organizations as it sets out requirements for compliance with international sta
Take a Peek Into Common Critical Findings Found in Compliance Auditing
Compliance auditing is an important component of regulatory compliance. It involves a thorough review of procedures, processes, and records to ensure