Friday, 12 April 2013


Quality Assurance is a vital part of drug development in the small pharmaceutical environment. It is the department which is responsible for ensuring that all the appropriate procedures have been followed and documented so that clinical progress can be made.

Today we are analysing two representative quality management directives in Pharmaceutical Industry.

ISO 15378:2011 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials. It is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

ISO 15378 is a complete, integrated quality management system standard combining ISO 9001:2000 and Good Manufacturing Practices (GMP) for Primary Pharmaceutical Packaging Materials. 

In addition to the complete requirements of ISO 9001:2000, ISO 15378 contains relevant GMP's for the design, manufacture and supply of packaging materials for medicinal products. 

These GMP's are based on a scientific, practical and cost effective balance, agreed following wide consultation and comment. 

The standard was published in 2006 as a full ISO, European Norm (EN) and British Standard (BS) and is an invaluable tool for Purchasing, Packaging Development, Supply Chain Management, Quality Assurance and Control and, more importantly, suppliers! 

ISO 15378 can be used for quality improvement, training, auditing and certification purposes. Accredited Certification can lead to formal recognition and Certified Supplier status. ISO 15378 is available from ISO and other registered sources. 

Moreover, ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product life cycle.

The ICH Q10 document on Pharmaceutical Quality System was adopted at Step 4 at the ICH Steering Committee meeting in June 2008. It 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".

By virtue of Article 6 of Directive 2003/94/EC and Directive 91/412/EEC manufacturing authorisation holders are already obliged to establish and implement an effective pharmaceutical quality assurance system in order to comply with Good Manufacturing Practice (GMP) and guidance is provided in Chapter 1 of the GMP Guide. 

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.

ICH Q10 provides an example of a pharmaceutical quality system designed for the entire product life cycle and therefore goes beyond current GMP requirements, which with the exception of the manufacture of investigational medicinal products for human use, do not apply to the development part of the lifecycle. At the time of the EU implementation of ICH Q10 it was also recognised that Chapters 1, 2 and 7 of the GMP Guide should be updated to align with the terminology and concepts utilised in ICH Q10.

The content of ICH Q10 that is additional to the scope of GMP is optional. Its use should facilitate innovation, continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.

Here you will find a brief guide that will help you get started for preparing Pharmaceutical QMS documents:

Sources: European Standards (CEN), ISO, FDA, ICH, EMA, Pharmout, ECA.

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