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Pharma 4.0

Pharma 4.0 from a quality and regulatory perspective.
The transformation from industrialisation (Pharma 2.0) towards digitalisation (Pharma 4.0) will require significant changes in the way of operating business. Nevertheless, there are some pre-conditions that need to be established before being capable of profiting from the new age. Together with your stakeholders Phact develops a tailor-made concept for your company to walk down the road to digitalisation.

The International Council for Harmonisation (ICH) illustrated the way to address the increasing complexity of the pharmaceutical business by issuing the ICH Q10 Guideline (“Pharmaceutical Quality System”, PQS). It implies a change in managing the business: From departmental thinking towards modern process orientation. It represents a key role for continual improvement, saving time, improving quality, reducing costs and increasing efficiency. The service package of Phact towards a PQS comprises, among others:

  • Implementing of a PQS according to ICH Q10
  • Designing the scope of the 4 major elements of a Pharmaceutical Quality System (Management Responsibility, Resources Management, Product Realization and Evaluation activities)
  • Identifying and adapting local and global needs of a PQS
  • Writing a Quality Manual
  • Creating process mapping and process flow diagrams
  • Analysing, optimising and alignment of the processes
  • Identifying reasonable Key Performance Indicators (KPIs) / Metrics for the processes
  • Combining GMP requirements with process related activities
  • Providing support during and monitoring of the implementation process
  • Assisting in change of the working style towards process orientation

Also in pharmaceutical manufacturing there is no thing such ‘no risk’. The International Council for Harmonisation (ICH) addressed this fact in the ICH Q9 Guideline (“Quality Risk Management”) and offers industry a set of tools to control risk. Phact assists in performing quality risk management activities either by developing an overall concept for a facility, organisational unit, project or a single case:

  • Analysing and identifying risks of business and manufacturing processes
  • Assessing the severity, probability of occurrence and detectability of risks
  • Determining risk indicators: ‘Primary Risk Number’ (PRN) and ‘Risk Priority Number’ (RPN)
  • Identifying methodology for risk assessment
  • Proposing measurements to reduce and control risks
  • Investigating and justifying acceptable risks
  • Communicating the risks

Knowledge Management is described in ICH Q10 as an enabler for a Pharmaceutical Quality System (PQS). With the implementation of Knowledge Management, a company ensures that the right knowledge is provided at the right time to the right people. Concepts for Knowledge Management are already widely practiced at other industries and are now going to enter into the pharmaceutical environment. Phact supports the implementation of practical concepts of Knowledge Management:

  • Analysing the situation regarding Knowledge Management in terms of product lifecycles, process improvements and people’s expertise
  • Identifying the available knowledge
  • Establishing the Knowledge Management cycle
  • Defining what knowledge is needed / needs to be captured
  • Storing, visualising and sharing expertise amongst the company
  • Utilising knowledge systematically
  • Setting knowledge-related goals
  • Capturing knowledge and expertise of employees

The application of Knowledge Management (which includes data management) is a key in moving towards Pharma 4.0. Knowledge Management transforms data into information and will form the basis for knowledge-based decision making processes.

As more and more data are generated the reliability of them needs to be ensured. In terms of Pharma 4.0 this is a pre-condition for taking data-based decisions. Agencies around the world are concerned about the integrity of data and have started to assess how data are secured.

Current concepts to ensure data integrity can be described as the ALCOA concept (attributable, legible, contemporaneous, original, accurate) respectively the ALCOA+ concept (complete, consistent, enduring, available) which have to be applied throughout the life-cycle of the data storage time. Phact assesses the company’s data (electronic and/or hardcopy) and provides recommendations for improvement.

Towards Pharma 4.0 a company passes through a number of steps until Digital Maturity and finally the status of digitalisation is achieved. The level of Digital Maturity of a company is dependent on a number of factors which have to develop at the same pace otherwise the process of digitalisation is hold up.

These important factors relate to the architecture of the information systems, the infrastructure of the company, the mindset of the employees and thus culture that is dominating within the company and the development of an organisation towards process-based structures. Phact develops together with the involved stakeholders of a company the milestones that need to be achieved on the way to Digital Maturity.