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:
If you have any questions you would like to ask, please get in contact.