Publication

cGMP for the 21st century - take advantage of the changing regulatory climate

For years pharmaceutical companies have accepted low manufacturing yields and high compliance costs as inevitable consequences of operating in their industry. Fear of potential regulatory problems is perceived to outweigh all other considerations. As other industries have developed ever more sophisticated manufacturing techniques, realising massive cost savings and significant improvements in product quality, the pharmaceutical industry has remained stagnant. To achieve product quality, the industry continues to rely upon the traditional approach of end product testing and process validation.

This is a costly and time-consuming process which has been driven by the regulators and is deeply embedded in the industry. As most experts now recognise, this approach neither assures nor  improves product quality.

The challenge now facing pharmaceutical companies is to develop an approach which delivers benefits comparable to other leading industries whilst accommodating the pharmaceutical sector's unique business drivers and evolving regulatory climate.

PA is uniquely qualified to help companies face this challenge. Because the scope of the initiative is quite broad, we recommend companies approach it from three different levels: strategic, plant-level implementation and planning for new products. PA is experienced in delivering solutions at each of these levels, including integrated solutions which span across the range.