The pharmaceutical industry currently faces a major challenge in taking full advantage of the opportunities presented in large emerging markets. And more than ever, pharmaceutical companies need to introduce lean manufacturing techniques that will enhance profitability. As one of the world's leading industrial automation suppliers, Yokogawa is committed to delivering the best possible solutions for your best manufacturing practices.
Compliance with globalized regulations and guidelines
|Pharmaceutical companies operate in a global marketplace and the industry is encouraged to comply with international initiatives such as the PIC/S GMP Guide and the ICH Guidelines. GMP facilities need to follow established best practices and automated production equipment and computer systems are expected to adopt current computerized systems validation (CSV) practices such as GAMP.|
Need for a more rigorous approach to ensure product quality
|With pharmaceutical products, a rigorous scientific approach is needed to ensure product quality. The ICH quality guidelines call for a quality by design (QbD) approach in pharmaceutical development and manufacturing. Manufacturing facilities face the challenge of implementing innovative technologies such as process analytical technology (PAT) and are expected to introduce real time release (RTR) testing.|
Keeping up with a changing marketplace
|Pharmaceutical manufacturers are under pressure to keep up with changes such as the shift to low cost drugs in emerging markets and the requirement for drugs that effectively satisfy unmet medical needs. To operate at a profit, manufacturers are looking for ways to improve efficiency and increase productivity. Lean manufacturing is the key.|