The International Society for Pharmaceutical Engineering’s (ISPE) Pharma 4.0 Special Interest Group (SIG) has been working since 2015 to translate how Industry 4.0 impacts pharmaceutical regulations and pharma manufacturing’s unique requirements. ISPE elieves moving to Pharma 4.0 Technologies represents a competitive advantage to the extent that not embracing its potential might be a business risk.
According to the SIG operating model data integrity organization and processes and culture form the “foundation.” This makes sense because preparing your organization and people to reap the benefits of Pharma 4.0 Technologies goes well beyond just understanding new technology. It requires a comprehensive asset management strategy based on detailed mapping of all of the stakeholders which encompasses people and processes and ensures that new technology solutions align with the organization’s objectives and stakeholder requirements.
Aligning with asset management strategies
Due to the high level of regulatory scrutiny the typical pharma company has a fairly good handle on its physical assets. They know the assets they have and understand the validated operating parameters. They typically perform an asset importance analysis based on the assets direct exposure to the product. They have specific standard operating procedures (SOPs) that govern how their products are manufactured and a strong quality management system and #0; QMSand #1; who oversees compliance and approves Corrective and Preventive Actions (CAPAs) of ias investigations.
However many organizations fail to implement an effective Pharma 4.0 Technologies strategy because they lack the ability and insight to scale their particular digital transformation and align it with a strategic digital transformation. Overall asset management. These organizations often lack sufficient foundational asset management skills to leverage technologies that will (theoretically) improve organizational performance. To achieve a positive return on investment from 4.0 initiatives companies must master the fundamentals to realize the potential benefits of advanced engineering tools.
Preparing people for the 4.0 environment
Just as you identify problems with the design, operation and maintenance of your assets you also need to determine if you have the people and organizational skills. to operate in
4.0 environment or not. ICH Q10 (pharmaceutical quality systems) and ISO 55001 talk about the management requirement to provide qualified competent resources. Figure 2 shows the sections of the ISO 55001 standard that are specific to asset management systems.
The “support” section is about using resources to achieve these asset management goals. It is concerned with determining not only the processes to be followed and the technologies to be used but also with the competence of the people who will do the work. The standard specifies that an organization has a process in place for determining competence requirements for asset management and for assessing the capacity of resources both internal and external.
Is your business ready for a change?
ICH Q10 and ISO 55001 also recognize the need for an organization to be able to change – not only to change systems or policies but also to adapt to new ways of doing things. This is very relevant when considering the requirements for an organization engaged in digital transformation. To reap the benefits and return on investment an organization needs a structured approach to adapting to change. If your employees aren’t ready to adopt new ways of working the power of enabling technologies is lost.
When it comes to implementing wealth management best practices, implementing new technologies is relatively easy. The hard part is changing the culture – getting people to adopt a new way of doing business when they may have been doing a jo a certain way for 30 years. What is needed is Organizational Change Management (OCM). Prosci a world leader in change management best practice research describes a CMO as “the application of a structured process and a set of tools to direct the people of change to achieve change. desired outcome”.
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