Comprehensive validation & certification
In many companies, validation of the analytical instruments used is required during the quality assurance process. This specifically concerns the calibration of our optical emission spectrometers and the validation of our elemental analyzers which are used in the GMP (Good Manufacturing Practice) regulated environment. The GMP guidelines specifically concern the manufacture of drugs and active pharmaceutical ingredients, but also cosmetics, food and animal feed.
An essential element of validation is the qualification of the instruments which are used for analysis. Thus, it can be verified that the analyzer carries out the designated tasks according to expectations. To support you in this verification process, we offer various instrument qualifications.
Installation Qualification (IQ)
The Installation Qualification (IQ) is issued on one occasion on installation of the instrument. The IQ verifies and documents that the analyzer was delivered in accordance with the requirements set by the Design Qualification (DQ) and was correctly installed. It also checks that the working environment meets the prerequisites for operation.
Operational Qualification (OQ)
The Operational Qualification (OQ) is carried out on a regular basis and monitors the correct functioning of the analyzer in the working environment. The OQ verifies and documents that the analyzer functions in accordance with operational specifications.
Performance Qualification (PQ)
The Performance Qualification (PQ) concerns and monitors use of the analyzer on a regular basis within the entire production process. The PQ verifies and documents that the analyzer consistently meets the defined performance parameters under real production conditions and thus delivers reliable results sustainable in the long-term.
Certification of calibration
We offer regular monitoring of calibration specially for our optical emission spectrometers (OES). Our service carries out analytical monitoring of calibration with recognized reference materials. After successful examination - and recalibration in case of need - you will receive a certificate of correct calibration as auditable verification. With regular monitoring of the calibration you will also ensure that your OES always supplies reliable readings.
GMP Guide: Ready for the audit
In this GMP guide, we collected information for you how to ensure GMP conformity of your analytical processes with qualifications, software and services. Furthermore, it contains application examples in the field of CHNOS analysis of different pharmaceutical samples, peptide content analysis, TOC analysis and cleaning validation as well as ADME studies in the product development phase.
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