Very high demands are placed on the quality and reliability of products used in medical engineering. Quality assurance is therefore an essential item in national and international laws and directives.
Examples of these include the German Medicine Act (AMG) relating to the manufacture of medicines in Germany; the Code of Federal Regulations (CFR), which forms the legal basis of the US Food and Drugs Administration (FDA); the Good Manufacturing Practice (GMP) code of practice with its adjuncts; the Pharmaceutical Inspection Convention (PIC); and the relevant standards of ISO 9000ff. These laws, directives and guidelines require that all processes, systems and activities directly or indirectly related to product manufacture must be validated.
The responsibility for validation lies with the company subject to regulation, which must establish guidelines and procedures to fulfil the legal requirements. Good Automated Manufacturing Practice (GAMP) serves here as an internationally recognised code of practice for validation. It describes the tasks and duties of the supplier and the end user, together with the validation process.
Zwick supports its customers in the qualification of testing machines – a significant component of validation – in the form of comprehensive individual qualification documentation and in performing qualification on-site.
Documentation is individually adapted and produced to suit the equipment of the testing system. Regulatory requirements are observed during creation of the documentation and all documents are to be authorised in advance by the customer.
Experienced service technicians carry out the qualification at the customer’s premises on the basis of the qualification documentation produced. The individual test items are performed and each Installation Qualification (IQ) or Operational Qualification (OQ) test subsequently signed by qualifier and end user. The results of IQ and OQ are summarised in the IQ and OQ plan and report and all discrepancies found during IQ and OQ are documented, assessed as critical or non-critical and measures to eliminate them are evolved.