03 Jun 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, requires 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.
Smart Features in the Manufacturing Process
Incorporating smart technology throughout the manufacturing process allows data collection, monitoring, and remote management. Tangible improvement in the manufacturing process requires careful consideration so that a practical strategy can be created. Incorporating new technology can be overwhelming due to the tremendous number of processes, equipment, data and conditions that are involved. Determining the smart tech that would be of the most benefit to the plant requires a knowledgeable and experienced team.
The main component of having smart features incorporated 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.
Provide Real Time Data and Analysis
Data has to be visible in real time and provided in an easy to review, transparent dashboard. Managers should have analysis at their fingertips to allow for insights for decision making. Standardization across processes should produce predictable outcomes. Automation of settings allows the facility to adapt to changes easily. Automation of workflows and asset performance allows higher reliability. All of these features should be wrapped up into a single customized software solution.
Integrate Life Cycle Data from Research through Manufacturing
The FDA has increased compliance measures to include production and warehousing. Quality control and consistency should flow throughout the manufacturing process to delivery of an approved product. The big picture should include 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 should be presented in a simplified, concise way.
A Highly Experienced Partner
There is no substitute for experience. A provider that can offer a wide suite of services can ease the burden of compliance. Albireo Energy has capabilities in installation, integration, monitoring, validation services and documentation, and commissioning. Albireo can deliver all the elements listed here and more. Albireo’s expertise and their 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 will also increase efficiency and reduce the number of recalls or rejected product that comes 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. So that personnel can focus on running the production process, partnering with a highly experienced provider like Albireo Energy can ensure that the facility stays compliant and can improve over time. The Albireo team is stacked with expertise in GMP/GLP services. The Albireo suite of software solutions specifically for the life science industry will deliver an integrated solution that will include smart connected systems with the latest technology that can operate confluently and efficiently.