Validation
 Tested quality guarantees efficient products.We have high expectations for the quality of our products. Therefore quality is a built-in feature, which determines the demands on R&D and the production process. The product life cycle is governed and backed by a quality management system that is certified under DIN EN ISO 9001. Prior to the release of a product, it is a requirement that all specifications are met and testing is successfully completed, which means conformance to the principles of Good Manufacturing Practices. Qualification and validation are basic elements of the quality assurance system of pharmaceutical manufacturers. We are able to support that process with qualifacation documentation and offer advice and consulting for the execution of tests. A detailed qualification documentation, which conforms to current standards and the GAMP regulations, is available for our products. We are able to give support for risk assessment and the definition of specific test criteria for conducting validation tests. On request we can also do the tests including the test records on site. In addition to that we can assist in updating the qualification documentation for re-qualification and re-validation in the framework of “Change Control”, if required after major technical modifications on the inspection system and/or packaging line. Please contact us - we will be pleased to give you any advice you may require and to submit a customised offer for qualification or re-qualification of your packaging equipment. |
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