PharmOut GMP Whitepapers and Brochures

PharmOut Whitepapers on Engineering

Pharma lean manufacturing – reduction of duplicationMore informationDownload
Prevention of Contamination and Cross-Contamination in Medicinal Manufacturing FacilitiesMore informationDownload
10 common problems with maintenance in a pharmaceutical plantDownload
New changes to cleanroom and clean air device classificationsDownload
Dehumidification in humid climatesDownload

PharmOut Whitepapers on Good Documentation Practice

Code of GMP Chapter 4. Documentation – PIC/S versus EUDownload
How to implement good documentation practicesDownload

PharmOut Whitepapers on Good Manufacturing Practice

The 10 golden rules of GMPDownload
Implementation of ANSI/AAMI/IEC 62304 Medical Device Software Lifecycle ProcessesDownload
Medical device risk management using ISO 14971Download
PIC/S GMP Guide Annex 1 – Revisions and InterpretationsDownload
FDA dietary supplement GMPs – how to complyDownload
Preparing for GMP audits (TGA-centric, but appropriate for all regulators)Download
Data Integrity ChecklistDownload

PharmOut Whitepapers on Qualification & Validation

EU GMP Guide-Annex 15 Qualification & Validation draft releasedDownload
Top 10 considerations when validating an autoclaveDownload
FDA guidance for industry update – process validationDownload
EMA Draft Guidance: Process ValidationDownload

PharmOut Whitepapers on Quality Management Systems

Review of Risk Management Processes in Software DevelopmentDownload
Authorised Person TrainingDownload
Process CapabilityDownload
How to implement a QMSDownload

PharmOut Whitepapers on Regulatory Issues

Elemental impurities ICH guidanceDownload
Comparison of Medical Device Standards and Regulations – ISO13485 and US FDA CFR part 820Download
How to list or register a complementary medicine in AustraliaMore informationDownload
How to register a prescription medicine in AustraliaMore informationDownload
How to list or register medicines in AustraliaMore informationDownload
How to register medical devices in AustraliaDownload
IVD device registrationDownload

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