PIC/s Annex 2A for ATMPs – GMP Regulation Updates
This article provides an introduction to the PIC/S Annex 2A updates in Version 15 in relation to Good…
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:…
MHRA GMP Audit – Summary of 2019 – 2020 Inspections (PQS deficiencies)
Top 10 MHRA GMP Audit deficiencies (2019 – 2020 analysis) Summary article for Education Purposes only. If you…
HVAC system specifications and requirements: pharmaceutical manufacturing
When it comes to HVAC system specifications and requirements for pharmaceutical facilities – including cleanroom designs – getting…
Good Clinical Practice (GCP) Inspections Program
New online courses available for clinical trials and GCP compliance training. The latest online training courses at www.onlinegmptraining.com…
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…
Pharmaceutical Water For Injection (WFI)
What is Water For Injection (WFI)? How does water quality for injectable pharmaceuticals (known as Water For Injection…
Industry Updates: PDA and FDA Joint Regulatory Conference
Our GMP courses, e-learning courses and GMP Forums repeatedly get great reviews by people who need to know…
Does my product require FDA approval?
FDA Pre-Approval Requirements Will your product need pre-approval from the FDA before you can sell it to the…
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