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

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EMA Draft Guidance: Process ValidationDownload
Computer System 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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