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Process and Product Optimization case Histories in Pharma

Case Study: Integrated Quality Risk Management



  • Integrate Quality Risk Management and Quality System Management (R&D and Manufacturing)
  • Increase company’s process/product knowledge
  • Reduce project cost, time, and resource investment and future investment

  • Business Risk Assessment & Planning
  • Guideline Implementation Phase SOP
  • Implementation Phase & Continuous Improvement


In the last few years, regulatory authorities set a new and even higher bar of mandatory quality for pharmaceutical companies. Part of this elevated quality is the systematic and scientific approach as defined by ICH Q9. Two years ago a leading global pharmaceutical company implemented QRM across the entire organization for all new products and lifecycle, including the new combination product, all while:
1) Not interrupting or delaying the current program;
2) Not increasing the number of resources;
3) Providing effective interpretation of the new QMS with other risk aspects managed in the company (i.e. portfolio risk management, project risk management).
The project objectives were to:

  • Align the company Quality approach to the new Quality Risk concepts which were introduced by guidelines/standards ICH Q9 (pharmaceuticals/ biologics) and ISO 14971(medical devices);
  • Merge two existing QMSs (R&D and Manufacturing) into a shared system which would then be fully integrated with the QRM system to form a single, shared IQRM;
  • Increase the company’s knowledge of its processes/products, in order to develop and produce new products and ultimately save cost, time and resources through a better decision making system (QRM).


By becoming integral team members of various departments we defined and deployed the IQRM strategy. We divided the project into three main steps: Business Risk Assessment & Planning, Guideline Implementation and SOP Implementation & Continuous Improvement. The project used a top-down approach to implement processes and culture change, to shift from two stand-alone systems, to one, integrated system. A bottoms-up approach was
necessary for continuous improvement and optimization change.

Business Risk Assessment & Planning Phase

Risk management is always present in a company, as it makes decisions daily. This may not be an explicit, formal or objective system, but it is still a risk management approach. We analyzed the Client’s Risk Management (RM) processes through our propriety software which maps processes. By understanding their existing structure and decision making process, we classified information to identify what was essential, significant and consistent.
From this, we applied a risk management process to the existing implementation process without adding complexity or increasing resources. We generated a priority list stating where risk management implementation had to be applied first. Other elements of integration evaluated were
1) How to increase knowledge about and transform the quality risk information into a business decision-making criteria (incorporate communication with portfolio & project risk management);
2) How to increase knowledge about and use quality risk information to implement the company portfolio strategy.

Guideline Implementation Phase

At this stage we translated ICH Q9 and ISO 14971 according to the existing QMS, and harmonized this and the information from the prior step to form an IQRM. We then gained Senior Management endorsement as they were actively involved in developing the QRM guideline and risk acceptability criteria definition. Two main objectives were used to deploy the guidelines:
1) Quality and Safety Risk Management had to be part of the business management system. Therefore, at the management level, QRM was integrated into the Company Operational Risk Management process;
2) Effort and level of documentation had to vary as a function of the project maturity level (early stage, high level RM, Phase III, very detailed RM) in order to share knowledge amongst internal staff, as well as provide documentation to regulatory bodies.

SOP Implementation & Continuous Improvement Phase

According to the gap analysis’results, the IQRM Team reviewed SOPs, such as, Technology Transfer from R&D to Manufacturing, Process Validation, Change Control and Non Conformities. All the SOPs that included a decision process which impacted product quality were reviewed according to IQRM principles. For each, the team identified the necessary resources to be involved and established a training program which was executed according to the QRM Guidelines and SOPs. Some pilot projects (i.e. development of formulation in different dosages, technology transfer of a new drug delivery system from R&D to Manufacturing, risk-based validation of a new building or equipment) were done in parallel to gain real feedback of implementation results. These were necessary to develop the new approach with built-in continuous improvement, while constantly referencing existing work. We ensured less effort and risk was applied and with minimal impact to current business. With this new, more efficient way to analyse risk and quality, the Client saved time and used less resources when making a well-informed decision as they now had better visibility into their process, and could now assure quality across the entire product lifecycle.


We established a pragmatic approach which allowed the Client to well understand the new, elevated quality level and adopt a shared integrated risk management approach based on scientific knowledge. This methodology ensured a high quality product to the patient. It also shared product knowledge across the organization to improve their decision-making processes both internally, within the organization and externally, with regulatory bodies. Finally,
by making the process more efficient, the Client significantly reduced costs related to the combination product development and manufacturing.