Key Focus Areas for Digitalisation in Pharma Key Focus Areas for Digitalisation in Pharma
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Key Focus Areas for Digitalisation in Pharma

Pharma Tech Outlook | Thursday, April 27, 2023

Digitalisation can improve efficiency and productivity in pharmaceuticals, but CDMOs face unique challenges. Collaboration, automation, and GMP focus can lead to successful implementation.

FREMONT, CA: The pharmaceutical industry is one of the fastest-growing economic sectors in the world. Its core is the research, development, production, and marketing of drugs and biologicals for human or biological use. To improve supply chain efficiency, digitalisation, and forecast consumer demand, which involves the integration of information through connected devices and systems, is being utilised. The industry is also facing challenges such as patent expirations, increasing customer demands, rising competition, and pricing pressures, which are driving digital transformation. The old product-oriented business model is being replaced by digital services integrated into the range of offers. Digital transformation is changing healthcare, and connected health has the potential to benefit all stakeholders by providing better care, and increasing health outcomes.

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The pharmaceutical industry is known for its high-profit margins, high-risk nature, strict regulations, lengthy and capital-incentive research and development periods and extensive marketing efforts. In this sector, digitalisation and data analytics can play a vital role in reducing the significant downtime that pharmaceutical plants often face.

The pharmaceutical industry requires strict control and has a high-reward nature due to its long and investment-heavy R&D periods. Digitalisation and data analytics can help minimise downtime and reduce mistakes in production, which can have severe consequences for patients and reduce mistakes in production, which have severe consequences for patients and, manufacturers alike. Automation through machine-to-machine communications, machine learning, and the Internet of Things allows for seamless procedures, automatic corrective actions, and predictive maintenance.  To avoid data transfer concerns, pharmaceutical companies have introduced digital sensors and robotics and invested in high-availability computing technology to automate production lines and improve demand-supply management. While pharmaceutical companies are still experimenting with digital services beyond traditional products, digital transformation is having a significant impact on the industry.

Good Manufacturing Practice (GMP) Within Pharmaceuticals

GMP refers to a set of regulations governing the manufacturing practices of medical products, food, and blood in different countries. Compliance with GMP regulations is essential for businesses to ensure that their products are safe and effective. By adopting a quality-oriented approach to manufacturing, businesses can minimise contamination, mix-ups, and errors. GMO regulations require companies to establish and maintain procedures, reliable testing, quality raw materials, deviation detection and investigation, and record keeping. Compliance with GMP rules covers staff qualifications, sanitation, equipment verification, cleanliness, and process validation.

Enforcement of GMP

GMP is a set of regulations that aim to ensure the safety, efficiency, and quality of pharmaceutical products, as well as other FDA-regulated products. The FDA has published 24 final guideline documents for GMP in the pharmaceutical industry, covering various aspects such as process validation and data integrity. GMP requirements are also inspected by national bodies in many other countries, and pre-approval inspections are conducted for GMP compliance before marketing authorisation of new medicine.

The consequences of GMP violations can vary based on the type of violation and medication involved. Even if a medication produced in violation of GMP meets the listed criteria, the risk of it being harmful or ineffective is low. Regulatory agencies, like the FDA, will provide specific recommendations based on the situation and healthcare providers will make decisions that balance risks and benefits for their patients. The FDA may take regulatory actions against companies with inadequate GMP to prevent the distribution of potentially dangerous or ineffective medications, but only in extreme cases for illegal products.

Therefore, regulation agencies provide tailored recommendations, and healthcare providers are best equipped to assess the risks and benefits for their patients. Regulatory action against companies with inadequate GMP is taken to prevent the release of potentially dangerous or ineffective medications, but the FDA only intervenes in exceptional cases involving illegal products.

Digitalisation plays a crucial role in improving the efficiency and productivity of the pharmaceutical industry, and Contract Development Manufacture Organisations (CDMOs) face unique challenges in digitalising their processes. To succeed in digitalising, the industry must focus on Good Manufacturing Practices (GMP) and collaborate closely with changing stakeholders. Additionally, the process of digitalisation should include increased use of robotics, automation solutions, and computerisation to reduce costs, improve efficiency, and be flexible to changes.

While there are challenges to implementing digitalisation in the pharmaceutical industry, such as the complexity of the development and manufacturing processes, there are also opportunities to improve drug production and meet the growing demand for both traditional and new drugs. By focusing on GMP and practical solutions for successful implementation, CDMOs can successfully implement digitalisation and improve the pharmaceutical industry as a whole.

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