If you think there’s too much red tape in your industry, spare a thought for pharma. Pharma manufacturers are subject to 76,000 restrictions–and with patients’ lives on the line, they need to take every one of them seriously.
What can other industries learn from how pharma ensures compliance with all these regulations and still maintains productivity?
While no other industry is so strictly regulated, sectors like chemicals, food and beverage, and auto manufacturing all face major compliance hurdles–and we’re likely to see regulators in every industry taking a pharma-style, data-driven approach to compliance in the near future. That means now is the time for manufacturers across sectors to start learning from pharma.
- Compliance from the start
With so many regulations to meet, pharma manufacturers set out to ensure compliance from the start, building compliance into designs and validating equipment performance from the outset. They use Quality by Design (QbD), a strategic product development and manufacturing process, to make sure each product comes out exactly as expected. This requires well-defined objectives and effective risk management from day one.
Every industry can learn from this. Establishing objectives at the start of the design phase, and developing a process to meet industry standards and minimise risk, can save time and money and ensure quality.
Quality assurance needs to be ongoing, including consistently monitoring inline critical process parameters as well as offline composition tests, and constantly recording data. Thorough records allow manufacturers to jump on any compliance issues as soon as they arise.
- Full digitalisation
Pharma is leading the way in digitalisation, and again, every industry can learn from this. Having a proper system for continuous collection of quality data can give manufacturers full transparency at every stage of the manufacturing process, enabling them to go back to any product or batch of products and see exactly what went wrong in production.
It also enables production to go paperless and eliminate human error in record-keeping. A cutting-edge data acquisition platform like COPA-DATA’s zenon platform not only collects data automatically, but can also automatically raise alarms when anything goes wrong, and these can be referred back to later.
Pharma may be more highly regulated than other industries, but that’s exactly why every industry can learn from how pharma is making compliance work.