PharmOut Whitepapers on Engineering
Pharma lean manufacturing – reduction of duplication | More information | Download |
Prevention of Contamination and Cross-Contamination in Medicinal Manufacturing Facilities | More information | Download |
10 common problems with maintenance in a pharmaceutical plant | Download | |
New changes to cleanroom and clean air device classifications | Download | |
Dehumidification in humid climates | Download |
PharmOut Whitepapers on Good Documentation Practice
How to implement good documentation practices | Download |
PharmOut Whitepapers on Good Manufacturing Practice
The 10 golden rules of GMP | Download | |
Implementation of ANSI/AAMI/IEC 62304 Medical Device Software Lifecycle Processes | Download | |
Medical device risk management using ISO 14971 | Download | |
PIC/S GMP Guide Annex 1 – Revisions and Interpretations | Download | |
FDA dietary supplement GMPs – how to comply | Download | |
Preparing for GMP audits (TGA-centric, but appropriate for all regulators) | Download | |
Data Integrity Checklist | Download |
PharmOut Whitepapers on Qualification & Validation
PharmOut Whitepapers on Regulatory Issues
Elemental impurities ICH guidance | Download | |
Comparison of Medical Device Standards and Regulations – ISO13485 and US FDA CFR part 820 | Download | |
How to list or register a complementary medicine in Australia | More information | Download |
How to register a prescription medicine in Australia | More information | Download |
How to list or register medicines in Australia | More information | Download |
How to register medical devices in Australia | Download | |
IVD device registration | Download |
More Information:
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