The ICH Q10 GuidelineThe ICH Q10 guideline describes a model for an effective quality management system for the pharmaceutical industry or a ‘pharmaceutical quality system’. It advocates preventative action culture to ensure that actions are taken before problems happen. It also facilitates the use of ICH Q8 and Q9. It is based on ISO 9000 with an emphasis on management responsibilities, improvement of QS and improvement of product quality over its lifecycle. Its scope is across pharmaceutical drug substances (API) and drug products, including biotechnology and biological products. The elements of a pharmaceutical quality system (PQS) encourage the use of scientific and risk-based approaches at each lifecycle stage.
Three main objectives to a new pharmaceutical quality system:
- Achieve Product Realisation– Having a system in place that allows delivery of products with the quality attributes appropriate to meet the needs of the patient.
- Establish and Maintain a state of Control– To develop and use effective monitoring and control systems for process performance and product quality ie. Use of QRM (Quality risk management).
- Facilitate Continual Improvement –Identify and implement appropriate product quality improvement, process improvement, variability reduction, innovation and pharmaceutical quality system enhancement.
The PQS covers the entire lifecycle of the product including:
- Pharmaceutical development
- Technology transfer
- Commercial manufacturing
- Product discontinuation
The PQS elements are used in each lifecycle stage to identify areas for continual improvement, these include:
- Process performance and product Quality monitoring system – ensure that a state of control is maintained, provide assurance of continuous capability of process controls to produce a product of the desired quality.
- Corrective Action/Preventative Action (CAPA) system– this system should result in product and process improvements.
- Change management system– System to evaluate, approve and implement changes identified from innovation, CI, CAPA, Audits. Must be implemented ensuring no unintended consequences from the change.
- Management Review- Product quality review must be carried out at various levels of investigation, deviation, Audit findings and CAPA effectiveness.
The enablers of ICH Q10 are:
- Knowledge management –Product and process knowledge should be managed and developed through the commercial life of the product and up to discontinuation.
- Quality risk management-This is integral to an effective PQS. Applying QRM provides a proactive approach to identifying, scientifically evaluating and controlling potential risks to Quality. (ICH Q9)
The Importance of the Quality ManualThe company must have an appropriate Quality manual in place, which must include details of the:
- Quality policy
- Scope of the pharmaceutical quality system
- Identification of the PQS processes, sequences, linkages and interdependencies
- Management responsibilities within the pharmaceutical quality system.
- Management commitment
- Establishment of the Quality Policy
- Quality planning
- Resource management
- Internal communications and ensuring that all communications are understood by all levels of staff.
- Management reviews to ensure continuing suitability and effectiveness of the PQS and assessments of the conclusions of periodic reviews of the process and performance and product quality.
- Manage outsourced activities and purchase of materials
- Manage changes in product ownership.
For continuous improvement of the pharmaceutical quality system the below activities must be conducted:Management review of the pharmaceutical quality system, review must include:
- Measurement of achievement of pharmaceutical quality system objectives, assessment of performance indicators ie: complaints, deviations, CAPA and change management process.
- Feedback on outsources activities
- Self-assessment process including risk assessments, trending, and audits.
- Emerging regulations, guidance and quality issues
- Innovations that enhance PQS
- Changes in business environment and objectives
- Change in product ownership
- Improvements to the pharmaceutical quality system and related processes.
- Allocation and reallocation of resources
- Revisions to quality policy and quality objectives
- Documentation and timely and effective communication of the results of management review and actions.
And Finally….ICH Q10 is signed up to as the quality system of choice by the regulatory authorities and industry representative for US, Europe and Japan as they are a permanent member of the ICH. This is the first quality system that is ratified in this way. ICH Q10 provides a mechanism for having a quality system that covers the entire lifecycle of the product; from R&D to product discontinuation. The appropriate level and rigour being applied dependent on the stage in the lifecycle. ICH Q10 describes mechanisms with feedback and enablers to facilitate the continuously improve the quality system and increase product knowledge.
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Further Reading from Acorn Regulatorymore than 5600 orphan designated drugs in the biopharmaceutical pipeline. As the sector continues to grow there has been a tendency for facts about orphan drugs to get lost in the midst of issues concerning specific patients’ needs, pricing and availability. We look at some facts about orphan designation that companies considering entering the sector should be aware of. Read more about orphan drugs here. Title V of Directive 2001/83/EC on the ‘Community code relating to medicinal products for human use’ (as amended). Read more about medicinal product labelling here.
- Companies that maintain control of electronic publishing at the corporate and head office level
- Others that have retained the day-to-day eCTD maintenance and lifecycle at a local level
- Companies that have outsourced eCTD entirely