Reducing Safety Risks in Pharmaceutical Manufacturing

Modern data management, through a fully compliant Enterprise Resource Planning (ERP) system, can help life sciences organizations comply with regulations and follow current Good Manufacturing Practices for the benefit of all.

Complexity in drug manufacturing is on the rise, and so is risk. New gene- and cellular-based advanced medical therapies, for example, require specialized handling and controlled temperatures to ensure safety and efficacy.

As science advances and the compliance landscape evolves, it’s more important than ever for pharmaceutical companies, biotech firms, and medical device manufacturers—and any contract manufacturing organizations (CMOs) and contract development manufacturing organizations (CDMOs) they work with—to follow advanced supply chain and quality management processes.

For most life sciences organizations, this means implementing modern—also known as digital—and comprehensive data collection and analytics systems, which comply with specific regulatory requirements worldwide and facilitate current good manufacturing practices (cGMP).

Inspections and Regulations Are Necessary but Not Sufficient

While regulatory bodies periodically inspect drug production facilities to see if they’re adequately following guidelines and mandates, the life sciences industry still reports disturbing levels of product recalls, defects, and drug shortages.

Life sciences companies are directly responsible, or must trust their CMOs and CDMOs, to:

• Obtain the appropriate raw materials/components
• Follow strict operating procedures
• Detect and investigate product quality deviations
• Maintain reliable testing laboratories
• Track inventory

Digital data collection and analytics systems make it possible for life sciences organizations to transform product quality oversight into a quantitative assessment, making it easier to improve accuracy and address issues before they become serious problems.

With their data houses in order—mainly through a comprehensive Enterprise Resource Planning (ERP) system that’s purpose-built for the life sciences industry—life sciences organizations can gain many benefits, such as the ability to:

• Accurately manage the strength, purity, and quality of all marketed products and investigational medicines, in full compliance with requirements from health authorities and other regulators worldwide
• Effectively audit internal and external operations to identify, document, and address deviations from cGMPs and other relevant regulations
• Monitor medicines for the possible presence of potentially harmful compounds
• Eliminate complex paperwork storage and make it much easier to search and analyze data

Get Proactive about Safety and Win in the Marketplace

A formal system of automated processes and controls, if adequately put into practice, can reduce the safety risks in pharmaceutical manufacturing by preventing contamination, mix-ups, deviations, failures, and errors.

Digital management through an ERP is certainly a far cry from the current reliance on spreadsheets and manual transcription for handling the massive amounts of data generated as part of manufacturing processes.

Eliminating repetitive manual work and creating a single, real-time source of truth minimizes the risk of human error and facilitates collaboration and transparency, all in the service of ensuring safety, quality, and efficacy.

Learn how STAEDEAN can help you ensure safety, quality, and efficacy of your life sciences products