PharmOut Whitepapers and Brochures

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

Good Documentation Practice

Code of GMP Chapter 4. Documentation – PIC/S versus EU Download
How to implement good documentation practices Download

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

Qualification & Validation

EU GMP Guide-Annex 15 Qualification & Validation draft released Download
Top 10 considerations when validating an autoclave Download
FDA guidance for industry update – process validation Download
EMA Draft Guidance: Process Validation Download

Quality Management Systems

Review of Risk Management Processes in Software Development Download
Authorised Person Training Download
Process Capability Download
How to implement a QMS Download

Regulatory

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 Download
How to register medical devices in Australia Download
IVD device registration Download

PharmOut Whitepapers and PharmOut Brochures

PharmOut WhitePapers and PharmOut Brochures are downloadable from this page.

  • PharmOut’s Project Management services Download
  • PharmOut’s Computer System Validation services Download
  • PharmOut’s Audit Readiness Assessment service Download

Checklists and References

  • Quality Risk Assessment example Download

To learn more: