Tuesday, April 14, 2009

US FDA provides model for ICH Q10 implementation

ICH Q10 quality control system shows industry and regulatory authorities' support of an effective pharma 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.

The US Food and Drug Administration (FDA) has provided a model for implementing the ICH Q10 quality control system. The ICH Q10 is one comprehensive model for an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) quality concepts. Much of the content of ICH Q10 is applicable to manufacturing sites, which is specified by the good manufacturing practices (GMP) requirements. The ICH Q10 is not intended to create any new expectations beyond current regulatory requirements. It provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product and intends to use together with regional GMP requirements.

The implementation aspects of ICH Q10 not covered by GMP, but it is optional. However, by adopting the additional processes outlined in the US FDA's guidance manufacturers should benefit from the innovation and improvement that are central tenets of ICH Q10.

Implementation of the Q10 model should result in achievement of three main objectives that complement or enhance regional GMP requirements - Achieve product realization; Establish and maintain a state of control' and facilitate continual improvement. The use of knowledge management and quality risk management will enable a company to implement ICH Q10 effectively and successfully.

In addition unlike GMP ICH Q10 explicitly covers all aspects of a product's lifecycle, from development through to discontinuation, and is designed to strengthen the link between pre- and post-commercialisation manufacturing activities.

Within this framework the US FDA identifies three main objectives: achieve product realisation, establish and maintain a state of control and facilitate continual improvement. To achieve these goals the FDA recommends companies use knowledge and quality risk management, with the guidance detailing how these ICH Q10 "enablers" should be used.

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