A Strategic Approach to Meeting the FDA’s CGMP Requirements

The Importance of Staying Current

The “C” in CGMP is an important component. Equipment implemented a decade ago may no longer be adequate under current standards. Outdated processes may not align with today’s best practices. Pharmaceutical manufacturers must continually review their operations to ensure they meet current requirements.

A continuous improvement approach benefits the business. By staying agile and innovative, pharmaceutical manufacturers can optimize their operations, maximize uptime and gain competitive advantages.

Technology Solutions for CGMP Compliance

By streamlining their manufacturing processes, pharmaceutical manufacturers can simplify their operations and make it easier to comply with CGMP. Companies should also manage their supply chains to controls costs, mitigate risks and ensure inventory traceability. Several technologies can aid in this effort:

Internet of Things

Like all manufacturers, pharmaceutical manufacturers must take steps to prevent equipment failures that can delay production and sap productivity. Pharmaceutical manufacturers must also adhere to strict standards for “cold supply chain” management. IoT devices can monitor floor activity and collect valuable data that makes it possible to predict equipment maintenance needs to maximize uptime. Cold supply chain sensing ensures that pharmaceuticals and raw materials are kept in temperature-controlled conditions at every phase of operations. IoT integrated with AI also has the potential to improve advanced therapies such as CAR-T. IoT and AI can help tailor CAR-T therapy for individual patients, improving effectiveness, reducing adverse effects and accelerating the progress of CAR-T development.

Networking and Wireless

A robust wired and wireless network is essential for connecting smart machines, supporting IoT devices and enabling connectivity. Pharmaceutical manufacturers need to ensure that their cabling infrastructure is up to date and that network devices deliver adequate performance. Companies can utilize distributed antenna systems to boost Wi-Fi coverage or utilize private 4G/5G cellular to enable long-range mobility, ultra-low latency and greater security.

Security

Pharmaceutical manufacturing facilities are a potential goldmine for thieves and saboteurs. Valuable products and raw materials, expensive equipment and personnel must be protected from potential threats. A layered security approach should include access controls, video surveillance and intrusion detection. AI-enabled video analytics can review footage in real time to spot suspicious activity and analyze data to spot trends and provide greater insight into incidents.

Safety

FDA regulations don’t just apply to manufacturing processes — they include strict requirements for employee safety. Pharmaceutical manufacturers should ensure that employees have adequate training in safety regulations, equipment and procedures, whether that training is delivered onsite or online. Connected safety devices can monitor compliance and detect hazardous conditions. They can also provide advanced analytics and predictive safety measures to cut down on incidents, lost time and revenue, and other risks.

Pro A/V

Effective communication is essential across every area of the manufacturing plant. Digital signage helps pharmaceutical manufacturers keep employees informed of new policies and announcements. It can also be used for training sessions and safety reminders. Paging and mass notification systems should be visible as well as auditory to ensure that all employees are alerted of safety concerns.

Power Generation

Power consumption is a major concern of pharmaceutical manufacturers, particularly during the conversion of natural substances into pharmaceutical substances. Manufacturers must also ensure consistent, reliable power for maintaining proper temperature, humidity, pressurization and cleanliness. As a result, electrical transmission and distribution and utility metering are critical components of the pharmaceutical manufacturing environment.

How Wesco Supports Pharmaceutical Manufacturers

Wesco’s technology solutions help pharmaceutical manufacturers improve processes, reduce costs and meet regulatory requirements. We also help them explore new techniques and equipment to address changing requirements and business goals. Our Technology and Support Services Team closes skills gaps with expert advice and technical insight into emerging technologies. With our global reach and strong supply chain, we help design and deliver innovative solutions to keep operations running smoothly.