Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pharmaceutical quality system.

Resource Management

(a) Management should determine and provide adequate and appropriate resources (human, financial, materials, facilities and equipment) to implement and maintain the pharmaceutical quality system and continually improve its effectiveness.
(b) Management show specific product, process or site.

Internal Communication

(a) Management should ensure appropriate communication processes are established and implemented within the organisation.
(b) Communications processes should ensure the flow of appropriate information between all levels of the company.
(c) Communication processes should ensure the appropriate and timely escalation of certain product quality and pharmaceutical quality system issues.

Management Review

(a) Senior management should be responsible for pharmaceutical quality system governance through management review to ensure its continuing suitability and effectiveness.
(b) Management should assess the conclusions of periodic reviews of process performance and product quality and of the pharmaceutical quality system, as described in Sections of ICH Q10.

Management of Outsourced Activities and Purchased Materials

The pharmaceutical quality system, including the management responsibilities described in this section, extends to the control and review of any outsourced activities and quality of purchased materials. The pharmaceutical company is ultimately responsible to ensure processes are in place to assure the control of outsourced activities and quality of purchased materials. These processes should incorporate quality risk management and include:
(a) Assessing prior to outsourcing operations or selecting material suppliers, the suitability and competence of the other party to carry out the activity or provide the material using a defined supply chain (e.g., audits, material evaluations, qualification);
(b) Defining the responsibilities and communication processes for quality-related activities of the involved parties. For outsourced activities, this should be included in a written agreement between the contract giver and contract acceptor;
(c) Monitoring and review of the performance of the contract acceptor or the quality of the material from the provider, and the identification and implementation of any needed improvements;
(d) Monitoring incoming ingredients and materials to ensure they are from approved sources using the agreed supply chain.

Management of Change in Product Ownership

When product ownership changes, (e.g., through acquisitions) management should consider the complexity of this and ensure:
(a) The ongoing responsibilities are defined for each company involved;ld ensure that resources are appropriately applied to ab) The necessary information is transferred.


This section describes the lifecycle stage goals and the four specific pharmaceutical quality system elements that augment regional requirements to achieve the ICH Q10 objectives, as defined in Section of ICH Q10. It does not restate all regional GMP requirements.

Lifecycle Stage Goals

The goals of each product lifecycle stage are described below.

Pharmaceutical Development

The goal of pharmaceutical development activities is to design a product and its manufacturing process to consistently deliver the intended performance and meet the needs of patients and healthcare professionals, and regulatory authorities and internal customers’ requirements. Approaches to pharmaceutical development are described in ICH Q8. The results of exploratory and clinical development studies, while outside the scope of this guidance, are inputs to pharmaceutical development.

Technology Transfer

The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realisation. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement.

Commercial Manufacturing

The goals of manufacturing activities include achieving product realisation, establishing and maintaining a state of control and facilitating continual improvement. The pharmaceutical quality system should assure that the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded.

Product Discontinuation

The goal of product discontinuation activities is to manage the terminal stage of the product lifecycle effectively. For product discontinuation, a pre-defined approach should be used to manage activities such as retention of documentation and samples and continued product assessment (e.g., complaint handling and stability) and reporting in accordance with regulatory requirements.


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