Since 2002, InphA has a quality management system according to DIN EN ISO 17025 in place which is accredited by the German accreditation body DAkkS. Our accreditation certificate is available here. All the test methods covered by the accreditation are listed as an attachment to the certificate. They are covered by a flexible scope of accreditation, since InphA as an OMCL does not conduct routine analyses, but has to transfer and apply different methods. As a consequence, no prior information of or approval by DAkkS is needed in order to modify, improve or newly develop test methods.
InphA quality goals
The employees have committed themselves to the following quality goals:
- Provide our services impartial, independent and with integrity
- High level of customer satisfaction through high quality of services
- Process orders just in time
- Warrant economic efficiency when executing the services
- Adhere to legal regulations and technical guidelines
- Determine and rectify the root causes of internal quality deficiencies and risks
- Continuous training and advancement of all employees
- Provision of suitable equipment
These targets are achieved by defining, among other things, the responsibilities and procedures in writing and by regular training of all the employees.
Quality assurance within the OMCL network
InphA is a member of the European OMCL network, a voluntary association of OMCLs (Official Medicines Control Laboratories) in Europe. The network is coordinated by the EDQM (European Directorate for the Quality of Medicines & Healthcare) in Strasbourg. An essential aspect of this cooperation is quality assurance which includes, for instance:
- participation in interlaboratory comparisons, required by ISO/IEC 17025. InphA takes part in about five to seven interlaboratory comparisons (PTS = proficiency testing studies) per year.
- participation in the MJA (Mutual Joint Audit) programme of the OMCL network: In this programme, the European OMCLs take part in a voluntary inspection by experts of the OMCL network, where they are tested for adherence to the OMCL specific guidelines of the OMCL network, including the standard ISO/IEC 17025. This is meant as a confidence-building measure, which aims to be an addition to the national accreditation of the individual OMCLs for the mutual acceptance of the analytical results. InphA has successfully undergone an MJA in 2005, 2009, 2013, 2017 and 2021. The Audit-Attestation of the OMCL network can be found here.
- testing of centrally authorised medicinal products: In the mandate of the licensing body for Europe, the EMA (European Medicines Agency) in London, the EDQM coordinates the sampling and testing of centrally authorised products (CAP). Since 2002, InphA has been taking part regularly in the testing of samples from this programme.
- taking part in market surveillance studies (MSS): Selected medicinal products are taken from the supply chain all over Europe and tested by the OMCLs according to a standardised test procedure to provide an overall picture of their quality. As part of an MSS, a common testing sample (CTS) is tested by all participating OMCLs which allows an assessment if the test procedure was correctly applied. InphA has regularly been taking part in the MSS program for many years.
WHO prequalified Quality Control Laboratory
Based on an assessment by WHO inspectors InphA is considered to be operating at an acceptable level of compliance with WHO recommended standards. In April 2014 InphA therefore was included in the WHO list of prequalified Quality Control Laboratories. The list comprises Quality Control Laboratories from all around the globe. It is a tool for different UN-Organisations and others helping them to find reliable laboratories for the testing of medicinal products. More information can be found here (LINK zum PDF Audit Attestation_EDQM-MJA-172).