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…
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Get ready for an Audit
Get ready for an audit (how to train your employees) Need to get ready for an audit? How…
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Remote Inspections (Offsite Inspections)
Remote inspections: FAQs Remote Inspections & Offsite Auditing 10 Commandments for Conducting Remote Inspections (offsite inspections) FAQ 1:…
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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…
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HVAC system specifications and requirements: pharmaceutical manufacturing
When it comes to HVAC system specifications and requirements for pharmaceutical facilities – including cleanroom designs – getting…
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Non-Clinical and Clinical Trials: Drug Safety Monitoring Training
These courses are suitable for laboratory and clinical researchers who need to understand their legal responsibilities in non-clinical…
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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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Pharmaceutical Water For Injection (WFI)
What is Water For Injection (WFI)? How does water quality for injectable pharmaceuticals (known as Water For Injection…
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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…
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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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