ICH Requirements For Quality manual, Management commitment,Quality Planning & Quality policy (Pharmaceutical Quality System As Per ICH Q10)
ICH Q10 Guideline deals with Pharmaceutical Quality System which guides about Quality Manual, Management Commitment, Quality planning, Quality Policy & Quality risk management. Now let’s see what ICH Q10 say’s about Pharmaceutical Quality System Q10.
Achieve product realisation
To establish, implement and maintain a system that allows the delivery of products with the quality attributes appropriate to meet the needs of patients, health care professionals, regulatory authorities (including compliance with approved regulatory filings) and other internal and external customers.
Establish and maintain a state of control
To develop and use effective monitoring and control systems for process performance and product quality, thereby providing assurance of continued suitability and capability of processes. Quality risk management can be useful in identifying the monitoring and control systems.
Facilitate continual improvement
To identify and implement appropriate product quality improvements, process improvements, variability reduction, innovations and pharmaceutical quality system enhancements, thereby increasing the ability to fulfil quality needs consistently. Quality risk management can be useful for identifying and
prioritising areas for continual improvement.
Enablers: knowledge management and quality risk management
Use of knowledge management and quality risk management will enable a company to implement ICH Q10 effectively and successfully. These enablers will facilitate achievement of the objectives described in Section above by providing the means for science and risk based decisions related to product quality.
Product and process knowledge should be managed from development through the commercial life of the product up to and including product discontinuation. For example, development activities using scientific approaches provide knowledge for product and process understanding. Knowledge management is a systematic approach to acquiring, analysing, storing and disseminating information related to products, manufacturing processes and components. Sources of knowledge include, but are not limited to prior knowledge (public domain or internally documented); pharmaceutical development studies; technology transfer activities; process validation studies over the product lifecycle; manufacturing experience; innovation; continual improvement; and change management activities.
Quality risk management
Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. It facilitates continual improvement of process performance and product quality throughout the product lifecycle. ICH Q9 provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.
Design and content considerations
a) The design, organisation and documentation of the pharmaceutical quality system should be well structured and clear to facilitate common understanding and consistent application.
b) The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognising the different goals and knowledge available for each stage.
c) The size and complexity of the company’s activities should be taken into consideration when developing a new pharmaceutical quality system or modifying an existing one. The design of the pharmaceutical quality system should incorporate appropriate risk management principles. While some aspects of the pharmaceutical quality system can be company-wide and others site-specific, the effectiveness of the pharmaceutical quality system is normally demonstrated at the site level.
d) The pharmaceutical quality system should include appropriate processes, resources and responsibilities to provide assurance of the quality of outsourced activities and purchased materials as described in Section ICH Q10.
e) Management responsibilities, as described in Section ICH Q10, should be identified within the pharmaceutical quality system.
f) The pharmaceutical quality system should include the following elements, as described in Section ICH Q10: process performance and product quality monitoring, corrective and preventive action, change management and management review.
g) Performance indicators, as described in Section ICH Q10, should be identified and used to monitor the effectiveness of processes within the pharmaceutical quality system.
A Quality Manual or equivalent documentation approach should be established and should contain the description of the pharmaceutical quality system. The description should include:
a) The quality policy ;
b) The scope of the pharmaceutical quality system;
c) Identification of the pharmaceutical quality system processes, as well as their sequences, linkages and inter dependencies. Process maps and flow charts can be useful tools to facilitate depicting pharmaceutical quality system processes in a visual manner;
d) Management responsibilities within the pharmaceutical quality system.
Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pharmaceutical quality system.
a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that roles, responsibilities, and authorities are defined, communicated and implemented throughout the company.
b) Management should:
1) Participate in the design, implementation, monitoring and maintenance of an effective pharmaceutical quality system;
2) Demonstrate strong and visible support for the pharmaceutical quality system and ensure its implementation throughout their organisation;
3) Ensure a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management;
4) Define individual and collective roles, responsibilities, authorities and inter-relationships of all organisational units related to the pharmaceutical quality system. Ensure these interactions are communicated and understood at all levels of the organisation. An independent quality unit/structure with authority to fulfil certain pharmaceutical quality system responsibilities is required by regional regulations;
5) Conduct management reviews of process performance and product quality and of the pharmaceutical quality system;
6) Advocate continual improvement;
7) Commit appropriate resources.
a) Senior management should establish a quality policy that describes the overall intentions and direction of the company related to quality.
b) The quality policy should include an expectation to comply with applicable regulatory requirements and should facilitate continual improvement of the pharmaceutical quality system.
c) The quality policy should be communicated to and understood by personnel at all levels in the company.
d) The quality policy should be reviewed periodically for continuing effectiveness.
a) Senior management should ensure the quality objectives needed to implement the quality policy are defined and communicated.
b) Quality objectives should be supported by all relevant levels of the company.
c) Quality objectives should align with the company’s strategies and be consistent with the quality policy.
d) Management should provide the appropriate resources and training to achieve the quality objectives.
e) Performance indicators that measure progress against quality objectives should be established, monitored, communicated regularly and acted upon as appropriate as described in Section of this document.