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.

What testing specifications and protocols does Bonfiglioli Engineering follow?

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:

  • FDA 21 CFR part 210, Current GMP in Manufacturing, Processing, Packing or Holding of Drugs)
  • FDA 21 CFR part 11, Electronic Records; Electronic signatures, which is the equivalent of EudraLex Volume 4 – Annex 11, Computerised systems.

Knowledge of these regulations is key in every design stage of Bonfiglioli Engineering machines.

Qualification, Validation, and international guidelines for the pharmaceutical industry

What steps are taken during the documentation and validation phase to help your customers meet their regulatory requirements?

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:

  • Identifies and mitigates any risks that might cause the machine to operate in a manner that does not comply with GMP
  • Identifies any business risks for the customer
  • Identifies and corrects any safety hazards to the machine’s operator (as required by law)
  • Determines which critical machine functions require constant monitoring (e.g., we identify vital machine components that could pose a risk to the health of the patient using the product if they break or malfunction. These are monitored continuously.)
  • Determines which functions will be tested during the machine testing and qualification phase

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.

Complete validation services

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.

We are not just a machine manufacturer. We are your trusted partner for packaging integrity testing and analysis through feasibility studies, technical expertise, validation packages, product handling and custom-built solutions.

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