In a global economy, each new geography brings with it newer challenges and potential for business development. Pharma manufacturing is a truly global industry which relies heavily on collaboration along with research and development. Let us now look at some of the key industrial challenges faced from a GMP standpoint:
At the heart of the maintenance challenge lies the lack of a risk-based approach which can clearly outline the failure outcome and its impact on the operations. A quick reference grid has been provided below:
- Direct impact (product critical equipment) – Failure results in direct impact on product
- Indirect impact (process critical equipment) – Failure results in impact on quality of the product (mainly)
Such impact-based assessment with stricter workflow to initiate maintenance works can be a changemaker. Digital permit to work systems can designate such impact assessment within its workflow and logic – it achieves this by including ready-to-access risk assessment forms and checklists. Mandatory integration within the workflow ensures that the step is never skipped, and this maintains strict compliance.
Uniform staff training can skip a beat due to the large turnover and failure of oversight. This creates a vortex effect whereby a single point of error (human) can cause issues within multiple systems. Such erroneous interdependencies can severely disrupt final product quality. In extreme cases, a product recall remains the only possible solution. Digital permit to work with a list of authorized users comes with the advantage to tackle the problem at source. One can only become user, if they complete and attend trainings.
Such digital check is simple, easy to integrate and maximizes the potential to successful maintenance outcomes.
Automation brings with it the best practices which are necessary to demonstrate in a GMP compliant environment. Here is a quick reference list of features that ensure right conditions for a strict compliance environment such as, GMP:
- Maintenance management information
- Live area map (for active sites)
- Ready to use risk assessments
- Proper job hazard analysis protocol
- Uniform and methodical communications
Digital platforms are also necessary for asset performance management. Pharma industry with its process driven approach demands a constant vigilance of its equipment. Large equipment are composed of smaller and much smaller components. Therefore, the granularity and attention to detail that each maintenance process requires becomes magnified.
Similarly, multiple work crews are needed to maintain the pace of operations which allow manufacturing to run smoothly. Digital permit to work can alleviate the effective communication and understanding gap by providing one platform to all crews. The management get to see what is happening, while the crews can run their maintenance operations more effectively.
Thus, bringing coherence and confidence to maintenance stream of activities in pharma manufacturing. Some of the future approaches which specialty pharma manufacturers are now adopting include:
- Impact assessment for maintenance within permit to work
- Introduction of Contractor management software to increase uniformity
- Preventive maintenance data collection from digital permit to work
Given the right application, pharma manufacturers can choose to adapt digital framework as per their requirements. This not only increases the accuracy, it paves the path for better user acceptance thus decreasing maintenance worries in the long term.