Qualification of Equipment as Part of Process Validation for Medical Devices

An essential part of quality management according to the General Medicine Act (MPG) and the US FDA's Code of Federal Regulations (CFR), is the validation of all processes, and equipment/computer-controlled systems which have direct impact on the quality of product manufacturing.

Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products. To qualify your machinery and equipment Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) are required to perform.

But what are the essential steps of each qualification? And which purposes do these qualification steps have?

Maical Singh (B.Eng.) is our skilled Medical Device Specialist in the field of IQ/OQ/PQ. He gained experience in global and mid-size medical device organizations in the fields development, quality and regulatory affairs.

Maical was so kind to give us an interesting insight in his special field (klick HERE to download).

Do you need any advise or assistance e.g. for manufacturing of your prefilled syringe, autoinjector, or on-body device project?

Don´t hesitate to contact us - we´re very happy to provide you a first opinion quickly and free of charge and to help you with your specific project challenge!