Leistungen GMP Auditierung
14. Januar 2021
Zicura ist ein Dienstleister für die Auditierung von Lieferanten, welche mit zu einem funktionierenden Qualitätsmanagement im Bereich der pharmazeutischen Herstellung zählt.
Im Bereich der GMP-Auditierung bieten wir Ihnen die Möglichkeit an Ihre Lieferanten zu auditieren – gerne auch als kosteneffizientes Verbundaudit (shared audit) inklusive Ihrer individuellen Fragestellungen.
Unsere Angebote im Bereich GMP umfassen:
Auditierung Ihrer Lieferanten
- Fertigarzneimittelhersteller von festen und halbfesten Darreichungsformen, Liquida, sterilen und aseptisch abgefüllten Produkten
- Auftragslaboratorien
- Wirkstoffhersteller u.a. von chemischen und pflanzlichen Wirkstoffen
- Hilfsstoffhersteller
- Primär- und Sekundärpackmittelhersteller von z.B. Folie, Glas und Kunststoffbehälter sowie Verschlüsse, bedruckte Packmaterialien wie Gebrauchsinformationen, Etiketten und Faltschachteln
Nachverfolgung
- Planung, Durchführung und Überwachung der Korrekturmaßnahmen
Bereits erstellte Auditberichte
- Berichte über bereits auditierte Unternehmen können erworben werden
Ihre Ansprechpartnerin im Bereich GMP-Auditierung:
Dr. rer. nat. Elena Jimenez Negro
Scannen Sie den QR Code oder melden Sie sich unter:
Elena.JimenezNegro@zicura.de
Tel.: 05921 7802 79
Unsere bereits terminierten & geplanten Audits finden Sie im Folgenden und können Sie hier herunterladen:
| Scheduled Audits | Status / Date | Audit report |
| November 2024 | ||
|---|---|---|
| Teva Group (Debrecen (Ungarn)) | scheduled 13.11.2024 | |
| Herbamed AG (Bühler (Schweiz) | scheduled 20 + 21.11.2024 | |
| VMP Chemikontor (Siegburg) | scheduled 13.11.2024 | |
| Plant Extract SRL (Romania) | scheduled 27. + 28.11.2024 | |
| Dezember 2024 | ||
| Farmalabor (Italien) | scheduled 18.12.2024 | |
| 2025 | | |
| January 2025 | ||
| Wiewelhove, (Ibbenbüren) | scheduled 15. + 16.01.2025 | |
| HEGO Heilkräuter Gorges GmbH & Co. KG, (Buch) | scheduled 21.01.2025 | |
| Sensoplast Packmitteltechnick GmbH, (Oberhonnefeld-Gierend) | scheduled 22.01.2025 | |
| February 2025 | ||
| Gärtnerei Schänzle Heilpflanzen, (Obermachtal) | scheduled 06.02.2025 | |
| GBA Pharma GmbH, (Standort Ulm) | scheduled 05.02.2025 | |
| Gerresheimer (GmbH), Essen, Tettau | scheduled 19.02.2025 | |
| March 2025 | ||
| Phytolab GmbH & Co. KG, (Vestenbergsgreuth) | scheduled 11. – 13.03.2025 | |
| Labor LS SE & Co. KG, (Bad Bocklett-Großenbach) | scheduled 26. + 27.03.2025 | |
| April 2025 | ||
| Gehrlicher Pharmazeutische Extrakte GmbH | scheduled 02.04.2025 | |
| Albert Friedrich Staphan, Zweibrücken | scheduled 29.04.2024 | |
| May 2025 | ||
| Hevert-Arzneimittel GmbH & Co. KG (Nussbaum & Bad Sobernheim) | scheduled 08.05.2025 | |
| Finzelberg GmbH & Co. KG, (Andernach und Sinzig) | scheduled 14. + 15.05.2025 | |
| June 2025 | ||
| Papierwerk Landshut Mittler GmbH & Co. KG, (Wörth an der Isar) | scheduled 25.06.2025 | |
| Swiss Caps GmbH (Bad Aibling) | scheduled 26.06.2025 | |
| July 2025 | ||
| Dr. Graner & Partner (München) | scheduled 15.07.2025 | |
| October 2025 | ||
| Dragenopharm Apotheker Püschl GmbH, (Tittmoning) | scheduled 08.10.2025 | |
| November 2025 | ||
| Alpinamed AG Freidorf & Standort Romanshorn (Schweiz) | scheduled 05.11.2025 | |
| Lichtenheldt GmbH, (Wahlstedt) | scheduled 12.11.2025 | |
| Heinlein Plastik Technik GmbH, Ansbach | scheduled 25.11.2025 | |
| Catalent Pharma Solutions GmbH, (Schorndorf) | scheduled 26.11.2025 | |
| Packsys GmbH, Feldafing | scheduled | |
| Phytoneering Extrakt Solutions GmbH (Bionorica (Neumarkt) | scheduled in Q3/2025 | |
| closed audits (reports available) | ||
| AC-Folie/Perlen Packaging Müllheim/ Perlen | closed November 2023 | available |
| Abtswinder Naturheilmittel GmbH & Co. KG, Abtswind | closed July 2022 | available |
| Agrimed Hessen w. V., Groß-Gerau | closed October 2022 | available |
| Albert Friedrich Stephan, Zweibrücken | closed April 2022 | available |
| Alpinamed AG, Freidorf & Standort Romanshorn (Schweiz) | closed Novemer 2023 | available |
| Alpha Pharma Service GmbH Heilbronn | closed May 2024 | available |
| Ardagh Glass GmbH (Bad Münder) | closed January 2024 | available |
| BAV Institut (Offenburg) | closed July 2024 | available |
| Berkel AHK Alkoholhandel GmbH & Co. KG, Lippstadt | closed May 2023 | available |
| BioChem Labor für biologische & chemische Analytik GmbH, Karlsruhe | closed June 2023 | available |
| Berghofanalytik Umweltengineering GmbH, Tübingen | closed November 2022 | available |
| Box-Druck Saarbrücken | closed November 2022 | available |
| BrüggemannAlcohol Heilbronn GmbH, Heilbronn (+ Wittenberg as „Back-up“ office) | closed Februar 2023 | available |
| Caesar & Loretz GmbH, CAELO, Bonn-Beuel & Standort Hilden | closed November 2023 | available |
| Catalent Pharma Solutions GmbH, Schorndorf | closed November 2022 | available |
| CFL Chemische Fabrik Lehrte GmbH & Co.KG, Lehrte | closed April 2023 | available |
| CG Chemikalien GmbH & Co. KG, Laatzen | closed September 2022 | available |
| Constantia (Fromm) Flexibles International GmbH, Remshalden | closed September 2023 | available |
| Deutsche Rondo GmbH, Kelkheim (Taunus) | closed May 2023 | available |
| DHU Arzneimittel GmbH & Co. KG | closed October 2024 | |
| Dragenopharm Apotheker Püschl GmbH, Tittmoning | closed September 2022 | available |
| DSG Biotec GmbH, Aschau/Chiemgau | closed February 2023 | available |
| Druckerei Bauer GmbH, Pfedelbach | closed September 2022 | available |
| Dyckerhoff (Köln) | closed April 2024 | available |
| etifix GmbH, Grafenberg | closed November 2022 | available |
| Etiketten und Druck Gerhard Eisele GmbH, Donsdorf | closed September 2022 | available |
| Eurofins Bio Pharma Product Testing (Hamburg) | closed March 2024 | available |
| Euromed, Barcelona, Spanien | closed February 2023 | available |
| Fagron GmbH & Co KG (Glinde) | closed October 2024 | |
| Finzelberg GmbH & Co. KG, Andernach und Sinzig | closed April 2022 | available |
| Gärtnerei Schänzle Heilpflanzen, Obermarchtal | closed September 2022 | available |
| GBA Pharma GmbH, Standort Ulm | closed June 2022 | available |
| Gerresheimer (GmbH), Essen, Tettau | closed May 2022 | available |
| Grillo Zinkoxid GmbH, Goslar | closed July 2023 | available |
| Gustav Heess Oleochemische Erzeugnisse GmbH Leonberg | closed July 2023 | available |
| Hänseler AG (Herisau) | closed April 2023 | available |
| Hans G. Werner, (Tornesch) | closed September 2024 | available |
| Hans Kolb Wellpappe GmbH & Co. KG Memmingen | closed January 2024 | available |
| HEGO Heilkräuter-Gorges GmbH & Co. KG, Buch | closed October 2022 | available |
| Heinlein Plastik Technik GmbH, Ansbach | closed December 2022 | available |
| Heinrich Klenk GmbH & Co. KG Schwebheim | closed May 2024 | available |
| HWI-Analytik GmbH, Rülzheim | closed February 2023 | available |
| Huttenlocher GmbH, Neckartailfingen | closed April 2023 | available |
| Joh. Vögele KG, Lauffen am Neckar | closed November 2022 | available |
| Joma Kunststofftechnik GmbH (Brunn am Gebirge (Österreich)) | closed April 2024 | available |
| Kräuter Mix GmbH (Abtswind) | closed November 2024 | |
| Kroha (AR Packaging) | closed July 2024 | available |
| Labor für analytische und pharmazeutische Chemie Dr. Graner & Partner GmbH | closed January 2022 | available |
| Labor LS SE & Co. KG, Bad Bocklet-Großenbach | closed February 2022 | available |
| L-A-W Services GmbH (Leipziger Arzneimittelwerk), Leipzig | closed March 2023 | available |
| Lichtenheldt GmbH, Wahlstedt | closed June 2022 | available |
| Linhardt GmbH & Co. KG (Pausa – Mühltroff & Viechtach) | closed June 2023 | available |
| Lonza- Capsugel (Bornem (Belgien)) | closed March 2024 | available |
| Ludgaia, Raron (Schweiz) | closed September 2022 | available |
| Magnesia GmbH, (Lüneburg) | closed June 2024 | available |
| Mauermann Arzneimittel, Pöcking | closed October 2023 | available |
| Meding GmbH, Hlaver-Oeckinghausen | closed April 2023 | available |
| MikroBiologie Krämer GmbH, Nalbach | closed November 2023 | available |
| Molkerei MEGGLE, Wasserburg | closed October 2023 | available |
| Ofimedicine (Leiden, NL) | closed October 2024 | |
| Packsys GmbH, Feldafing | closed September 2022 | available |
| Papierwerk Landshut Mittler GmbH & Co. KG, Wörth an der Isar | closed September 2022 | available |
| Paul W. Beyvers GmbH, Berlin | closed August 2022 | available |
| Pharma Aldenhoven GmbH & Co. KG, Aldenhoven | closed October 2023 | available |
| Phytochem Referenzsubstanzen GbRmbH, Ichenhausen, bzw. Neu-Ulm | closed November 2022 | available |
| PlantExtrakt S.R.L. | closed September 2021 | available |
| Rottendorf, Ennigerloh | closed October 2021 | available |
| Remy & Geiser GmbH is part of Bormioli Pharma Group (Schleusingen) | closed March 2024 | available |
| Sanner Group (Hungary) | closed April 2024 | available |
| Schuck GmbH, Schwaig | closed July 2022 | available |
| Schulz Flexgroup GmbH, Baden-Baden | closed January 2023 | available |
| Sensoplast Packmitteltechnik GmbH, Oberhonnefeld-Gierend | closed October 2022 | available |
| Solupharm Pharmazeutische Erzeugnisse GmbH, Melsungen | closed January 2023 | available |
| Stella Kunststofftechnik GmbH, Eltville am Rhein | closed March 2023 | available |
| Stölzle Oberglas GmbH, Köflach (Österreich) | closed November 2023 | available |
| Swiss Caps GmbH (Bad Eibling) | closed September 2022 | available |
| TECHPharm GmbH, (Bruchsal) | closed August 2022 | available |
| Tentamus Pharma & Med Deutschland GmbH (ehemals BLS-Analytik GmbH & Co. KG) (Bad Kissingen) | closed April 2024 | available |
| trans-o-flex Express GmbH, Weinheim | closed July 2023 | available |
| Variopack (Nidda-Harb) | closed May 2024 | available |
| Vitaplant AG, Uttwil, Schweiz | closed June 2023 | available |
| West Pharmaceutical Services Deutschland GmbH & Co. KG, Eschweiler | closed August 2022 | available |
| Wiewelhove GmbH, Ibbenbüren | closed July 2022 | available |