Innovation is the lifeblood of the pharmaceutical industry, occurring at every stage of the product lifecycle described in “The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)” guideline. This guideline elucidates the significance of the change management system, acknowledging variations in its application formality throughout the product lifecycle and the requirement to evaluate changes in accordance with regulatory submissions where appropriate.
Pharmaceutical companies face the challenge of balancing their adherence to the Good Manufacturing Practice (GMP) standards specified by regulatory authorities with the requirement to drive continual improvement in products, processes, and systems. Over the last decade or so, the implementation of a series of ICH guidelines has accelerated innovation throughout the lifecycle and the transfer of many aspects of change management ownership to pharmaceutical companies. This progressive regulation, combined with the advent of new manufacturing and analytical equipment and technology, has increased the emphasis on innovation and continual improvement of products, processes, and systems. Learn in detail about the impact of change management on the pharmaceutical industry and how it ensures innovations and improvements are managed effectively.