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Whitepapers

Engineering

Pharma lean manufacturing - reduction of duplication   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

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

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EMA Draft Guidance: Process Validation   Download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

Comparison of Medical Device Standards and Regulations - ISO13485 and US FDA CFR part 820 Published October 2014
  Download
How to list or register a complementary medicine in Australia Published July 2014
More information Download
How to register a prescription medicine in Australia Published July 2014
More information Download
How to list or register medicines in Australia Published August 2014
  Download
How to register medical devices in Australia   Download
IVD device registration   Download

PharmOut Brochures

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

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