Oct 22, 2021 | Technology, Industry

5 Key Elements for Easier Life Science GMP/GLP Compliance

No two biopharmaceutical manufacturing processes are the same, but they all require monitoring, alarming and reporting. The complexity of variables that need to be monitored, such as temperature, humidity and ventilation, demand precise and intensive data compilation and reporting so that managers can successfully obtain the answers they need to ensure compliance. There are many ways to make this painful process smoother.

1. Smart Features in the Manufacturing Process

Incorporating smart technology throughout the manufacturing process allows for data collection, monitoring and remote management. Tangible improvement in the manufacturing process requires careful consideration so that a practical strategy is created. Incorporating new technology can be overwhelming due to the tremendous number of processes, equipment, data and conditions that are involved.

2. Increased Connectivity

The main benefit of incorporating smart features into your manufacturing process is to increase connectivity. Business systems need to integrate data from internal operations, suppliers and customers. Control systems should include room pressurization readings, space temperature, humidity levels and lighting schedules. Equipment, such as freezers, incubators, water treatment units and more should all be tied into the control system.

3. Provide Real Time Data and Analysis

Data must be visible in real time and displayed on an easy-to-review, transparent dashboard. Managers need analysis at their fingertips to determine insights and improve decision making. Standardization across processes produces predictable outcomes. Automation of settings allows the facility to adapt to changes easily. Automation of workflows and asset performance results in higher reliability. All these features should be wrapped up into a single customized software solution.

4. Integrate Life Cycle Data from Research through Manufacturing

The FDA increased compliance measures to include production and warehousing. Quality control and consistency need to flow throughout the manufacturing process to delivery of an approved product. The big picture includes quality assurance for air filtration, ventilation, air pressure, humidity temperature, as well as occupant comfort, employee schedules, equipment and facility maintenance schedules. Records and reports to show compliance must be presented in a simplified, concise way.

5. A Highly Experienced Partner

There is no substitute for experience. A provider that offers a wide suite of services eases the burden of compliance. Albireo Energy can deliver all the elements listed here and more. Our expertise and sterling reputation can lift the weight right off your shoulders.

The Pharma industry is heavily regulated. GMP compliance regulations are in place to enhance safety and quality. But GMP compliancy practices also increase efficiency and reduce the number of recalls or rejected product that come out of a facility. The compliant organization earns a trustworthy reputation that translates to the bottom line.  

Since the environmental conditions and process details are unique to each facility, the reliance on precision monitoring and reporting is tremendous. To allow personnel to focus on running the production process, partnering with a highly experienced provider like Albireo Energy ensures that the facility stays compliant and improves over time.

The Albireo team is stacked with expertise in GMP/GLP services. Our suite of software solutions specifically for the life science industry delivers an integrated solution that features smart connected systems with the latest technology. Contact us to get started today.

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