Designing a pharmaceutical testing machine that complies with all international regulations and guidelines demands a long period of documentation, study, and monitoring. Angela Rosignoli, Validation and Documentation Team Manager at Bonfiglioli Engineering explained the main steps to provide companies with efficient machines that meet the qualification and validation phases required by inspection bodies.
Bonfiglioli Engineering equipment is designed to meet the specifications of international regulators and inspection bodies. To be specific, we draft our testing and qualification specifications as well as our protocols in accordance with EudraLex regulations, which govern the pharmaceuticals market in the EU. Our reference is Volume 4 (“Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary use”) - Annex 15 (“Qualification and Validation”).
For the global market, Bonfiglioli Engineering machines are designed in compliance with:
Knowledge of these regulations is key in every design stage of Bonfiglioli Engineering machines.
We use the V-model approach, developing documentation based on the customer's requests to determine which specifications the machine must have. Then, we design, build, write and execute the test protocols.
The design stage starts with risk analysis, which is performed by a multi-disciplinary team in accordance with ICH Q9 guidelines that offer guidance on the principles and some of the tools of quality risk management for effective and consistent risk based decisions. This analysis is a fundamental step that:
Acceptance testing is performed throughout machine design. This operating method, combined with risk analysis and internal audits in accordance with ISO 9001 Certified Quality Management System procedures, allows to intervene early if problems or unforeseen events arise at any stage of the design, production, and testing cycle. In this way, the machine has already been verified before the Factory Acceptance Test (equipment acceptance at the manufacturer’s) and Site Acceptance Test phases (equipment acceptance at the customer’s) and is ready to be put online.
In all these steps, we ensure that we follow the international regulations and guidelines and focus on the customer's needs to provide efficient equipment that is ready for acceptance.
Bonfiglioli Engineering offers its decades of experience in the pharmaceutical sector to its customers.
Along with custom machine design, Bonfiglioli Engineering service technicians offer complete validation services, including testing protocol and compilation phases. Both phases are fundamental to ensure a customer obtain regulatory approval. Bonfiglioli Engineering develops all its equipment and related documentation in accordance with GMP guidelines and international regulations, to provide our customers a complete service that guarantees that their machine will be approved and can be commissioned without a hitch.