Together with our customers, celares GmbH’s highly motivated team constantly evaluates and improves the performance of company processes, as well as research and development capabilities. Continuous Improvement and Customer SatisfactionĬontinuous improvement at celares GmbH has become a way of life. Additional test verifications are included to assure compliance with unique customer specifications when requested. Entsprechend 21 Absatz 9a Satz 1 des Krankenhausfinanzierungsgesetzes (KHG) bermittelt Mecklenburg-Vorpommern dem Bundesministerium fr Gesundheit. All our services and products are provided according to specifications set out by celares in close cooperation with our customers and undergo testing to assure conformity. Juli 2022 im Namen des Bundesministeriums für Arbeit und Soziales (BMAS) die Schulungsveranstaltung der Ergänzenden unabhängigen Teilhabeberatung (EUTB) zum ersten Mal in hybrider Form durch. Die Fachstelle Teilhabeberatung führte vom 7.
By involving our customers in this process, we are able to prioritize their requirements and prevent deviations in our performance. Hybride Schulungsveranstaltung 'Teilhabe stärken bedarfsorientierte Beratung in der EUTB'. We strongly emphasize Quality by Design and take preventive actions to build quality into our processes and products. We understand well the need for additional GMP inspections by the customers and can accommodate you in this regard.Ĭelares GmbH is committed to providing products and services with superior quality to our customers, and we have implemented a quality control system to assure this.
#Landesamt fuer gesundheit und soziales download
Thus, in December of 2019, celares received its GMP certification “for the release analytics of APIs.” ( Download the PDF) Since 02/2021 celares GmbH also holds a manufacturing authorization “for conjugate vaccines” ( Download the PDF). Was sind die Anzeichen für die Krankheit Informationen zur Schutzimpfung gegen COVID-19 mit mRNA-Impfstoffen in Leichter Sprache Auf den Seiten des Robert-Koch-Institutes finden Sie den Anamnese-Fragebogen für die Corona-Schutz-Impfung, das Aufklärungs-Merkblatt zur Schutz-Impfung und eine Erklärung für die Formulare. The quality control laboratory has been successfully inspected by the local authority (Landesamt für Gesundheit und Soziales – LaGeSo, Berlin). In its production facility and the quality control lab, which are are dedicated to the manufacturing of pharmaceutical excipients and APIs for use in clinical studies, celares has implemented GMP according to the EU-GMP-guidelines.
This provides the flexibility needed for development projects and at the same time ensures high quality standards.
#Landesamt fuer gesundheit und soziales iso
The international DIN EN ISO 9001:2015 norm applies to all branches of the company.
Contact details for the Berlin State Ethics Committee are as follows: Landesamt für Gesundheit und Soziales BerlinGeschäftsstelle der Ethik-Kommission des Landes BerlinFehrbelliner Platz 110707 BerlinTel.For each of its branches, celares has specified the tailored requirements for the quality management system. Administrative responsibility rests with the Berlin State Department for Health and Social Affairs (LaGeSo).Īll AMG research proposals which, between 6 August 2004 and 30 September 2005, were submitted to, and processed by, the Ethics Committee of the Faculty of Medicine of Charité – Universitätsmedizin Berlin and the Berlin Chamber of Physicians, fall under these new regulations. Controlling Authority Landesamt fr Gesundheit und Soziales Turmstrae 21, 10559 Berlin Germany. The new committee is referred to as the Berlin State Ethics Committee (Ethik-Kommission des Landes Berlin). A new law, which came into effect on 1 October 2005, transferred legal competence for this type of ethical review to the ethics committee administered by the state government of Berlin. On 30 September 2005, Charité EC lost its authorization for the review of clinical trials of investigational medicinal products under sections 40 - 42 of the AMG, following its amendment dated 30 July 2004, which came into effect on 6 August 2004. The relevant powers were transferred to the Berlin State Ethics Committee on 1 October 2005 As of midnight, 30 September 2005, this is no longer within the remit of the Charité EC.