Industry Solutions
Pharmaceutical Quality System (ICH Q10/ISO9001)
PharmOut provides off the shelf templates and consulting services
ISO 13485 Quality Systems and 21 CFR 820 Quality Systems are also available.
Introduction
ICH Q10 describes a comprehensive model for an effective pharmaceutical quality system that is based on International Standards Organisation (ISO 9001) quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 "Pharmaceutical Development" and ICH Q9 "Quality Risk Management" and ICH Q11 "Development and manufacture of drug substances".
ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle and much of the content of ICH Q10 is applicable to manufacturing sites is currently specified by regional GMP requirements.
ICH Q10 supports an effective pharmaceutical quality system to enhance the quality and availability of medicines around the world in the interest of public health. Implementation of ICH Q10 throughout the product lifecycle should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.
Approach
Our approach outlines an affordable and practical approach to successfully implement ISO 9001 sytle quality system. We provide starter templates, experience and consulting services to meet the needs of all sized suppliers to the pharmaceutical, biotech or medical device manufacturing companies or to the drug or device manufacturer to ensure compliance with ISO 9001:2008 or TGA GMP regulations.
Companies, typically complete registration to ISO 9001 / TGA compliance within 6 to 12 months. PharmOut has helped a number of 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?
Want to know more, follow this link to : Quality Pays.
Applicability of ISO to Drug and Biotech manufacturers
The ISO 9001:2008 Standard provides an excellent framework to develop a Quality System fully compliant with the PIC/S requirements as regulated by the TGA in Australia.
Whilst an ISO 9001 Quality System is not a specific requirement of the USA's Food and Drug Administration for drug manufacturers it is recommended as it which assists in compliance to the Code of Federal Regulations; in particular the 21 CFR 210 and 211.
Do you want to know more about our approach and how we can help you get to market quicker?