Qualification
and validation

Balda meets with the highest quality requirements as defined in
the "current Good Manufacturing Practice" (cGMP) and the speci-
fications pursuant to ISO 13485. Risk-based, routine implementation
of validation activities is an essential component for documenting
continuous process control. To this end, we normally make use of
a standardized package of in-house methods based on our own
validation strategy and meeting a whole variety of process and
customer requirements. Clear proof of compliance for qualification
of the systems and validation of the software and control systems
is supplied with the aid of individually planned qualification levels
DQ, IQ, OQ and PQ, as well as comprehensive documentation.

Quality awareness – every single day.


Six Sigma

We use Six Sigma to constantly improve our understanding of the processes and to boost quality. Processes are analysed on the basis of statistically planned tests (DoE’s) and can be sustainably improved with the aid of the resultant process model. Six Sigma projects are managed by specially trained members of staff known as Black and Green Belts. Processes are described, measured, analysed, improved and monitored in five phases using statistical methods. The aim is to stabilize production and ensure maximum utilization of efficiency potentials.

The aim is to stabilize production and ensure maximum utilization of efficiency potentials.


Measuring technique used is an essential
part of the process chain.

Measuring technique

Correct decisions in product development and industrial production are based on a sound database. During these phases, the measuring technique used is an essential part of the process chain and includes optical and tactile measurements, as well as the analysis and evaluation of components using digital data. These data are generated by laser scanning and computer tomography. Direct comparison with the CAD data rapidly yields secure results. Tactile and optical processes are also used in series production (in-process control); these are integrated as in-line processes or used for testing and inspection of state the art static - IT support samples. The measured values are automatically transmitted to a quality database for further evaluation.


Certification

Balda places exacting demands on quality. Validation and qualification during the industrialization phase are fundamental elements when designing processes and equipment items in conformity with GMP requirements. Balda locations are certified according to the following standards:

  • DIN EN ISO 9001
    (Quality management system – Requirements)
  • DIN EN ISO 13485
    (Medical products – Quality management systems –
    Requirements for regulatory purposes)
  • DIN EN ISO 15378
    (Primary packagings for medicinal products –
    Particular requirements for the application of ISO 9001,
    with reference to Good Manufacuring Practice (GMP)
  • MDD 93 / 42 / EWG
    (Medical Device Directive)
  • FDA registration

Validation and qualification are fundamental elements.