ISO 9001 for Pharmaceutical / Biotech Manufacturers

PharmOut provides Templates and Consulting Services to Small to Medium Sized Companies.

ISO 13485 Quality Systems are also available.

QSR / 21 CFR 820 Quality System are available.

INTRODUCTION

Our approach outlines an affordable and practical approach to successfully implement ISO 9001 systems. We provide templates, experience and consulting services to meet the needs of small / medium size pharmaceutical, biotech or medical device manufacturing companies, to ensure their registration to ISO 9001. Our systems also ensure compliance to the TGA’s and if necessary the FDA's requirements.

Companies, typically complete registration to ISO 9001 within 6 to 12 months. PharmOut will help clients achieve registration on schedule. By installing quality systems that will generate hard-dollar savings / improvements and operate with minimal costs and you will reap the rewards sooner.

Did you know that independent studies reveal that companies embracing Quality Improvement Programs perform better than those that don’t?

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Quality Pays.

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Practical Implementation of Quality Systems for Pharma and Medical Device Manufacturers?

Applicability of ISO to Pharma / Biotech

The ISO 9001:2000 Standard provides an excellent framework to develop a Quality System fully compliant with the PIC/S requirements as regulated by the TGA in Australia, and of through the MRA, Europe.

Whilst a Quality System is not a specific requirement of the USA's Food and Drug Administration it is recommended as it which assists in compliance to the Code of Federal Regulations; in particular the 21 CFR 210 and 211.