Downloads

PharmOut offers free download's that provide users with valuable industry insights from our leading and highly experienced staff.

White Papers

How to implement good documentation practices Download

Medical device risk management using ISO 14971 Download

The 10 golden rules of GMP Download

Code of GMP Chapter 4. Documentation - PIC/S versus EU Download

Process Capability Download

How to implement a QMS Download

10 common problems with maintenance in a pharmaceutical plant Download

How to validate an autoclave Download

PIC/S GMP Guide Annex 1 - Revisions and Interpretations Download

FDA guidance for industry update - process validation Download

How to register medicines in Australia Download

How to register medical devices in Australia Download

Pharma lean manufacturing - reduction of duplication Download

FDA dietary supplement GMPs - how to comply Download

Preparing for GMP audits (TGA-centric, but appropriate for all regulators) Download

New changes to cleanroom and clean air device classifications Download

IVD device registration.Download

EMA Draft Guidance: Process Validation Download

PharmOut Brochures

PharmOut corporate brochure Download

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

Maintenance self assessment against ISPE Baseline guidelines (2005) Download

Presentations

Quality By Design Download