Download White Papers, Checklists and Brochures

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White Papers

TGA GMP update new GMP code applies July 2010

This 'White Paper' discusses the GMP changes due to the adoption of the latest PIC/S code for Good Manufacturing Practice!
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PIC/S GMP Guide - Annex 1 Revisions & Interpretations

This 'White Paper' discusses the changes to Annex 1 affecting Australian pharmaceutical manufacturers due to the adoption of the latest PIC/S code for Good Manufacturing Practice!
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FDA update on Process Validation, new draft Guidance

This 'White Paper' discusses fundamental changes in the way the FDA think about Process Validation and maybe, other regulators minds as well?
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Ten Golden Rules of GMP

This is a classic and by far the most popular 'White Paper' - The Ten Golden Rules of GMP!
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How to prepare to a TGA GMP Audit

This follows our popular training on the subject with a few practical pointers on how to succeed in your next regulatory audit!
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How to Register a Medical Device in Australia

This white paper defines the 'how to' register Medical Devices in Australia.
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Lean Manufacturing

Lean Manufacturing is the determination of an efficient manufacturing process through the removal of waste. This white paper lists some of the common Lean / GMP concepts.
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New Dietary Supplement Good Manufacturing Practices (GMPs)

New Good Manufacturing Practices (GMP) for dietary supplements are effective 25th June 2008. This white paper highlights some of the key requirements that you will need to address in order to comply with Chapter 21 of the Code of Federal Regulations Part 111 (21 CFR part 111).
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10 Common Problems Pharma Plant Maintenance

This white paper lists some of the common GMP problems often associated with maintenance activities at pharma plants.
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Validating an Autoclave

This white paper discusses how to validate an Autoclave.
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Checklists, References.

Quick Reference Technical Document Writing Guide

This Quick reference guide is useful to clarify common issues associated with technical writing.
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Maintenance Self Checklist

This self assessment checklist is useful to determine the compliance gap in your maintenance department.
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Case Studies

Acrux Case Study

This case study discusses some of the common GMP problems often associated with technical writing.
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Brochures of Our Services

Audit Readiness Brochure

This white paper lists some of the common GMP problems often associated with maintenance activities at pharma plants.
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Computer System Validation

This brochure describes PharmOut's validation services for computerised systems.
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PharmOut Brochure

This brochure describes PharmOut's services.
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PharmOut Project Management Brochure

This brochure describes PharmOut's Project Management services.
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Brochures of Training Courses

On Site cGMP Training - The Basics

This brochure details our latest offerings regarding our on-site cGMP training.
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On Site GLP Training

This brochure details our latest offerings regarding our on-site GLP training.
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