Blood, Tissues, Biologicals & ATMPs Regulations in Australia
Ensuring Safety and Integrity: The Significance of Blood, Tissues, Biologicals & ATMPs Regulations in Australia In Australia, medicinal…
Counterfeit Drugs: A Growing Problem
Counterfeit drugs (fake pharmaceuticals and adulterated medicines) are a growing problem around the globe. It is estimated that…
Changes to PIC/S GMP
What updates or changes to PIC/S GMP Guidance do you need to understand; and what is the latest version of PIC/S GMP Guidance and PIC/S Annexes?
Top 10 GMP Audit Citations: FDA & TGA Inspections
FDA & TGA GMP Compliance Audit Citations for 2020, 2021, & 2022. Latest FDA inspection trends: common audit…
FDA Warning Letters on Data Integrity Issues
Batch release decisions — and other product safety evaluations — rely on data integrity. In this pharmaceutical industry…
Get ready for an Audit
Get ready for an audit (how to train your employees) Need to get ready for an audit? How…
Remote Inspections (Offsite Inspections)
Remote inspections: FAQs Remote Inspections & Offsite Auditing 10 Commandments for Conducting Remote Inspections (offsite inspections) FAQ 1:…
Medical Supply Chain Risks: Vulnerabilities and the Importance of GMP
Lean manufacturing and ‘just in time’ shipping strategies means medical supply chain risks are an ever-present phenomenon. But medical…
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