Process design

This is the first step that must be taken as part of any validation protocol, with production processes designed and tested for their ability to consistently bring out products that reach all necessary standards. This typically takes place in a laboratory and can be experimental, depending on the drug in question. Once each step of the process has been documented successfully, it’s time to move onto the next stage.

Qualification

This is the documentation of evidence that equipment, systems or facilities are ready for use, made up of three main elements – facility design, qualification of utilities and equipment, and process performance qualification.

Facility design involves the study of the process design from the previous stage in order to scale up commercially. This will include the selection of utilities, equipment, operating principles, technical specifications and so on.

From here, you need to verify that the requirements worked out during the facility design stage marry up with the physical specification of the equipment. And once this has been achieved, you can then move onto the continued process qualification stage.

This covers the entire duration of the manufacturing process, ensuring that the system continues on as it should. Neglecting this stage could mean that compromised batches of pharmaceuticals enter the market. It can be achieved through the regular maintenance of equipment, testing and sampling of products, swabbing and cleaning, and so on.

Here at Co-Packer, we can help you with all aspects of pharmaceutical consultation and validation, so get in touch with us if you’d like to find out more.