Good Manufacturing Practice, or GMP, is rapidly becoming commonplace in biopharmaceutical manufacturing. It may seem daunting, but individual companies don’t have to reinvent the wheel. Suppliers such as Hamilton provide full GMP solutions.
“GMP is a risk managememt system to ensure the quality of pharmaceutical systems”, explains Giovanni Campolongo, process analytics manager at Hamilton. “This doesn’t just mean that a medicinal product is ‘not harmful’. It also means that it has a significant therapeutical effect.”
‘The entire package has to be ready to be GMP compliant’
In Europe as well as North America, regulations are in place to ensure adherence to GMP. The objectives are strictly defined. How companies can achieve these objectives, however, is laid down in voluntary guidance. The most commonly applied voluntary standard is GAMP5: Good Automated Manufacturing Practice v.5. “This is also the standard that we use in the development of our own sensors, and in fact our full computerized systems”, says Campolongo.
According to GMP guidelines, a computerized system consists of all hardware, software and network components involved in product manufacturing, including the training of the people who operate the system, and all associated traceability documentation. Campolongo: “The entire package has to be ready to be GMP compliant. We often get the question: is your sensor GMP compliant? This is a logical error. A sensor can be ready for compliance.”
Suppliers such as Hamilton can assist their clients in the entire system lifecycle, from design qualification (what do you want the instrument to do?) via installation qualification (is it correctly connected?) and operation qualification (does it work for your specific application?) through to performance qualification (does it continue to be fit for purpose and controlled?).
GMP, as he continues, is a shared responsibility between the supplier and the end-user. “The end-user specifies and selects the instrument, reviews and approves the installation qualification, and confirms the intended use and the continued performance.
As an example, Campolongo names Hamiltan’s ArcAir computerized system. “We provide you with the process sensor, as well as the full deliverables package to validate it.” Hence, the computerized system does not only comprise the intelligent Arc Sensor with embedded microtransmitter and ArcAir software. In also includes storage of the sensor’s data into an encrypted database and many other features, such as user and rights management, logging of user actions, and digital reports. “GMP users don’t have to manage everything themselves”, emphasises Campolongo. “They can leverage on an experienced GMP supplier like Hamilton to identify the most suitable GMP package for the sensor’s intended use. You’ll also find this in the guidelines: ‘although the responsibility for compliance with GMP regulations lies with the regulated company, the supplier may have considerable involvement in the process’.”