Audit management
Your partner for all pharmaceutical audits
Search for your next audit from our database:
Order your audits in our web app and track them in real time:
We support you with high-quality 3rd party GxP audits.
With our many years of experience in the pharmaceutical industry since 2005 and over 80 audits per year, we are sure that we can also meet your specific requirements.
Your advantages at a glance:
- Local on site with offices in China and India
- High-quality reports in accordance with regulatory requirements
- from initial planning to the evaluation of CAPA measures
- Simple and fast processing
- Globally recognized expertise through highly qualified auditors
- High flexibility thanks to our global team of auditors
- Low fixed costs due to joint audits & Heacon’s own audit database
- > 1,500 audits carried out
- > 18 years of experience
Active pharmaceutical ingredients (APIs), excipients, starting materials, primary and secondary packaging materials, finished medicinal products or logistics: We are happy to take on your audit in all GxP-regulated areas, individually on your behalf or as part of a joint audit.
GMP
Quality, its assurance and control are central to the manufacture of medicinal products.
With our GMP audits, we help you to qualify your suppliers and thus ensure the quality and safety of your active ingredients and medicinal products control.
GDP audits ensure that the quality of medicinal products is guaranteed throughout the entire production and transport chain – from the place of manufacture to sale or use by authorized persons.
GMP audits at packaging manufacturers ensure the integrity and safety of pharmaceutical packaging.
Our audit program management (APM Board) ensures a functional and up-to-date QM system, efficient coordination and continuous qualification of our team.
Our QMS
Our modern Quality Management System (QMS) complies with the requirements of ISO 17020 and ISO 19011 in their current versions and guarantees the qualification of the auditors, the timely organization, as well as the procedure and scope of the audits according to the corresponding guidelines.
Do you need support in establishing, improving or modernizing your QM system?
Or would you like to check your system for weak points and inspection capability?
pharma-audit helps you to position yourself safely and exceed the expectations of the authorities!
- GAP analyses
- Creation of documents: SOPs, VMP, GMP room requirements, room qualification templates etc.
- Modernization and updating of the QMS
- Support in the implementation of qualifications and preparation of qualification documentation
- Preliminary risk assessments
Our GxP consultants put their many years of experience in the pharmaceutical industry at your disposal!
We are always informed about current trends in the pharmaceutical industry thanks to our geographical and operational proximity to the German Pharmaceutical Industry Association (BPI).
On site and digitally around the world.
pharma-audit
Search for your next audit from our database.
We support you with high-quality 3rd party GXP audits.
With our many years of experience in the pharmaceutical industry and over 600 audits – since 2015 – we are sure that we can also meet your specific requirements. Your benefits at a glance
We support you with high-quality 3rd party GXP audits.
With our many years of experience in the pharmaceutical industry and over 600 audits – since 2015 – we are sure that we can also meet your specific requirements. Your benefits at a glance
- high-quality reports in accordance with regulatory requirements.
- Simple and fast processing.
- globally recognized expertise by highly qualified auditors.
- High flexibility thanks to our worldwide team of auditors.
- Low fixed costs due to joint audits & audit database.
Lomapharm GmbH
Langes Feld 5, 31860 Emmerthal
DE
Langes Feld 5, 31860 Emmerthal
DE
planned
Ausstehend
Dyckerhoff Pharma GmbH & Co. KG
Robert-Perthe-Str. 49, 50739 Köln
DE
Robert-Perthe-Str. 49, 50739 Köln
DE
planned
Ausstehend
ACG Associated Capsules Pvt.Ltd
Gat No 322,323; Shindewadi, Post. Shirwal, Dist. Satara, Maharashtra Tal. Khandala 412801
IN
Gat No 322,323; Shindewadi, Post. Shirwal, Dist. Satara, Maharashtra Tal. Khandala 412801
IN
planned
Ausstehend
Hellmann Worldwide Logistics GmbH & Co. KG
Hans-Wittwer-Strasse 6, 04435 Schkeuditz
DE
Hans-Wittwer-Strasse 6, 04435 Schkeuditz
DE
planned
Ausstehend
Etimex
Martin-Adolff-Straße 44, 89165 Dietenheim
DE
Martin-Adolff-Straße 44, 89165 Dietenheim
DE
planned
Ausstehend
Kammann Thermologistik GmbH (H. Essers Group)
Siemensstraße 44
67227 Frankenthal
DE
Siemensstraße 44
67227 Frankenthal
DE
planned
Ausstehend
Solara Active Pharma Sciences Limited
Mathur Road, Periyakalapet, 605014 Puducherry
IN
Mathur Road, Periyakalapet, 605014 Puducherry
IN
planned
Ausstehend
ICE S.P.A (former Prodotti Chimici E Alimentari S.P.A)
Via Novi, 78, 15060 Basaluzzo
IT
Via Novi, 78, 15060 Basaluzzo
IT
planned
26.01.2024
Lupin Limited
Lupin Limited, 124 G.I.D.C. Estate, Bharuch, India-393 002 Ankleswhar, Gujarat
IN
Lupin Limited, 124 G.I.D.C. Estate, Bharuch, India-393 002 Ankleswhar, Gujarat
IN
planned
Ausstehend
Wuhan Grand Hoyo Co. Ltd.
436030 Ezhou, Hubei
CN
436030 Ezhou, Hubei
CN
planned
Ausstehend
Sichuan Xieli Pharmaceutical Co. Ltd.
No. 860 of Chaoyang South Road, Pengzhou, Sichuan 611930
CN
No. 860 of Chaoyang South Road, Pengzhou, Sichuan 611930
CN
planned
Ausstehend
Shandong Kunda Biotechnology Co., Ltd.
Economic Development Zone, Yishui, Linyi, Shandong, 276400
CN
Economic Development Zone, Yishui, Linyi, Shandong, 276400
CN
planned
Ausstehend
HWI development GmbH
Straßburger Str. 77, 77767 Appenweier
DE
Straßburger Str. 77, 77767 Appenweier
DE
planned
Ausstehend
PSI supply nv
Axxes Business Park, Guldensporenpark 22, Block C, 9820 Merelbeke
BE
Axxes Business Park, Guldensporenpark 22, Block C, 9820 Merelbeke
BE
planned
Ausstehend
IDT Biologika GmbH
Am Pharmapark
DE
Am Pharmapark
DE
planned
Ausstehend
CHELAB S.r.l. / Mérieux NutriSciences
Via Fratta 25 31023 Resana (Treviso) Italy
Via Fratta 25 31023 Resana (Treviso) Italy
planned
Ausstehend
Zhejiang Jiangbei Pharmaceutical Co.
Dongdai Village Zhang’an Street, Jiaojiang District, China – 318 017 Taizhou, Zhejiang Province
CN
Dongdai Village Zhang’an Street, Jiaojiang District, China – 318 017 Taizhou, Zhejiang Province
CN
planned
Ausstehend
Wacker Chemie AG
Friedrich-von-Heyden-Platz 1, 01612 Nünchritz
DE
Friedrich-von-Heyden-Platz 1, 01612 Nünchritz
DE
planned
Ausstehend
Curia Spain S.A.U. (former Crystal Pharma S.A.U.)
Parque Tecnológico de Boecillo, Parcela 105, 47151 Boecillo, Valladolid
ES
Parque Tecnológico de Boecillo, Parcela 105, 47151 Boecillo, Valladolid
ES
planned
Ausstehend
BCN Peptides S.A.
Pol. Ind. Els Vinyets-Els Fogars 2, 08777 St. Quinti De Mediona, Barcelona
ES
Pol. Ind. Els Vinyets-Els Fogars 2, 08777 St. Quinti De Mediona, Barcelona
ES
planned
Ausstehend
Archimica S.P.
Viale Milano 86, 26900 Lodi
IT
Viale Milano 86, 26900 Lodi
IT
planned
Ausstehend
Nantong Jinghua Pharmaceutical Co.,Ltd.
No.30.3 Haibin Road, Yanhai Econonic Development Zone, Rudong, Nantong Jiangsu, 226407
CN
No.30.3 Haibin Road, Yanhai Econonic Development Zone, Rudong, Nantong Jiangsu, 226407
CN
planned
Ausstehend
Gelita AG
Gammelsbacher Str., 69412 Eberbach
DE
Gammelsbacher Str., 69412 Eberbach
DE
planned
Ausstehend
LOSAN PHARMA GMBH
Otto Hahnstrasse, 13, D-79395- NEUENBURG
DE
Otto Hahnstrasse, 13, D-79395- NEUENBURG
DE
planned
Ausstehend
L-A-W Services GmbH
Elisabeth-Schumacher-Straße 54-56, 04328 Leipzig
DE
Elisabeth-Schumacher-Straße 54-56, 04328 Leipzig
DE
planned
Ausstehend
HPC Herbrand PharmaChemicals GmbH
Brambachstr. 31, 77723 Gengenbach
DE
Brambachstr. 31, 77723 Gengenbach
DE
planned
Ausstehend
Kinsy S.L.
Avda. Europa s/n, Parque Industrial Las Salinas, 30840 Alhama de Murcia
ES
Avda. Europa s/n, Parque Industrial Las Salinas, 30840 Alhama de Murcia
ES
planned
Ausstehend
Shandong Xinhua Pharmaceutical Co. Ltd. (Hutian)
Hutian Chemical Industrial Zone, 255075 Zibo, Shandong Province
CN
Hutian Chemical Industrial Zone, 255075 Zibo, Shandong Province
CN
planned
Ausstehend
Shandong Xinhua Pharmaceutical Co. Ltd. (Zibo)
East Chemical Zone of Zibo, High & New Technology Development Zone, Zibo, Shandong, 255005
CN
East Chemical Zone of Zibo, High & New Technology Development Zone, Zibo, Shandong, 255005
CN
planned
Ausstehend
Dipharma Francis S.R.L. (Caronno)
Via Origgio, 23, 21042 Caronno Pertusella
IT
Via Origgio, 23, 21042 Caronno Pertusella
IT
planned
Ausstehend
Bioquim Liofilizaciones SA
C/ Alemanya n° 1, Pol. Ind. Pla de Llerona, Les Franqueses del Vallés, 08520 Barcelona
ES
C/ Alemanya n° 1, Pol. Ind. Pla de Llerona, Les Franqueses del Vallés, 08520 Barcelona
ES
planned
Ausstehend
Olon S.p.A. (Casaletto Lodigiano)
Via Livelli 1, 26852 Casaletto Lodigiano, Frazione Mairano (LO)
IT
Via Livelli 1, 26852 Casaletto Lodigiano, Frazione Mairano (LO)
IT
planned
Ausstehend
Unitax Pharmalogistik GmbH
An den Gehren 1, 12529 Schönefeld
DE
An den Gehren 1, 12529 Schönefeld
DE
planned
Ausstehend
Moehs BCN, S.L.
Poligono Industrial Aquiiberia, Zenc 12, 08755 Castellbisbal, Barcelona
ES
Poligono Industrial Aquiiberia, Zenc 12, 08755 Castellbisbal, Barcelona
ES
scheduling
Ausstehend
Wavelength Enterprises Ltd. (Seqens)
Neot Hovav Eco - Industrial Park, P.O. Box 3593, Beer Sheva 8413502
IL
Neot Hovav Eco - Industrial Park, P.O. Box 3593, Beer Sheva 8413502
IL
fixed
08.11.2023
DSM Food Specialties B.V.
Alexander Fleminglaan 1 2613 AX Delft
NL
Alexander Fleminglaan 1 2613 AX Delft
NL
fixed
09.01.2024
CRO Beijing Fosun
#237 F22 Chaoyang North Rd., Chaoyang District, 100020 Beijing
CN
#237 F22 Chaoyang North Rd., Chaoyang District, 100020 Beijing
CN
scheduling
Ausstehend
Shanghai Chemo Wanbang Biopharma Co., LTD
No.1098, Yuegong Rd, Jinshan Disctrict, Shanghai
CN
No.1098, Yuegong Rd, Jinshan Disctrict, Shanghai
CN
scheduling
Ausstehend
Yumen Qianhua Pharmaceutical Co.,Ltd
No.8 Sanba road, Old City Chemical zone, Yumen, Jiuquan,Ganshu,China
CN
No.8 Sanba road, Old City Chemical zone, Yumen, Jiuquan,Ganshu,China
CN
planned
Ausstehend
CCL Healthcare
Ashford, United Kingdom Foster Road, Ashford Business Park Sevington, CCL Label, Ashford, Kent TN24 OSH
GB
Ashford, United Kingdom Foster Road, Ashford Business Park Sevington, CCL Label, Ashford, Kent TN24 OSH
GB
planned
Ausstehend
SAFC Biosciences (Merck)
13804 W. 107th Street, Lenaxa, Kansas 66215
US
13804 W. 107th Street, Lenaxa, Kansas 66215
US
rip
20.09.2023
Hankyu Hanshin Express
Cargo City Sued, Geb. 570, 60549 Frankfurt am Main
DE
Cargo City Sued, Geb. 570, 60549 Frankfurt am Main
DE
fixed
25.01.2024
Caldic Deutschland GmbH
Henkelstraße 67, 40589 Düsseldorf
DE
Henkelstraße 67, 40589 Düsseldorf
DE
scheduling
Ausstehend
JAS FORWARDING GmbH
An der Gehespitz 120, 63263 Neu-Isenburg
DE
An der Gehespitz 120, 63263 Neu-Isenburg
DE
scheduling
Ausstehend
Produtos Roche Quimicos e Farmaceuticos S/A
Estrada dos Bandeirantes 2020 Taquara, RJ, 22775-109
BR
Estrada dos Bandeirantes 2020 Taquara, RJ, 22775-109
BR
scheduling
Ausstehend
Kintetsu World Express (France) S.A.S.
294-296 avenue du Bois de la Pie BP 64077 Roissy en France 95973 Roissy Charles De Gaulle Cedex
FR
294-296 avenue du Bois de la Pie BP 64077 Roissy en France 95973 Roissy Charles De Gaulle Cedex
FR
planned
Ausstehend
Teva Private Ltd.
Malanpur, INDIA
IN
Malanpur, INDIA
IN
planned
Ausstehend
Avara Liscate Pharmaceutical Services S.p.A.
Via Fosse Ardeatine n°2, 20060 Liscate MI
IT
Via Fosse Ardeatine n°2, 20060 Liscate MI
IT
fixed
24.10.2023
Papierwerk Landshut Mittler GmbH & Co.KG
Siemensstr. 4, 84109 Wörth an der Isar
DE
Siemensstr. 4, 84109 Wörth an der Isar
DE
fixed
11.06.2024
Liveo Research GmbH
Schlossmattenstr. 2, 79268 Bötzingen
DE
Schlossmattenstr. 2, 79268 Bötzingen
DE
fixed
01.10.2024
ROMPHARM ROMANIA
Str. Eroilor 1A, Otopeni 075100
RO
Str. Eroilor 1A, Otopeni 075100
RO
fixed
19.10.2023
Laboratori DAU
Carrer C, 12-14, P.I. Zona Franca, 08040 Barcelona
ES
Carrer C, 12-14, P.I. Zona Franca, 08040 Barcelona
ES
fixed
10.10.2023
ZiO Zdorovie
(CJSC) Zheleznodrozhnya Street 2, Podolsk, Moscow region, 142103
RU
(CJSC) Zheleznodrozhnya Street 2, Podolsk, Moscow region, 142103
RU
fixed
21.11.2023
HHAC Labor Dr. Heusler GmbH
Hindenburgstr. 33, D-76297 Stutensee
DE
Hindenburgstr. 33, D-76297 Stutensee
DE
follow_up
07.09.2023
Spreewälder Arzneimittel GmbH
Schulstraße 9, 15913 Märkische Heide
DE
Schulstraße 9, 15913 Märkische Heide
DE
follow_up
13.07.2023
Laboratoire Renaudin SA
ZA Errobi, 64250 Itxassou
FR
ZA Errobi, 64250 Itxassou
FR
fixed
26.10.2023
Moehs CATALANA S.L. (IBERICA)
Polígono Rubí Sur, César Martinell i Brunet 12A 08191 Rubi (Barcelona)
ES
Polígono Rubí Sur, César Martinell i Brunet 12A 08191 Rubi (Barcelona)
ES
planned
Ausstehend
Moehs Cantabra, S.L.
Pol. Industrial Requejada City Polanco (Cantabria) 39313
ES
Pol. Industrial Requejada City Polanco (Cantabria) 39313
ES
planned
Ausstehend
Merck Life Science Technologies (Nantong) Co.,Ltd.
No.39 Jianggang Road, NETDA, Nantong, Jiangsu, China
CN
No.39 Jianggang Road, NETDA, Nantong, Jiangsu, China
CN
scheduling
Ausstehend
PMC ISOCHEM
4, Avenue Philippe Lebon, 92230 Gennevilliers
FR
4, Avenue Philippe Lebon, 92230 Gennevilliers
FR
scheduling
Ausstehend
Tentamus-Pharma UK
Orbis 3 building, Riverside Road, Pride Park Derby, DE24 8HY,UK
GB
Orbis 3 building, Riverside Road, Pride Park Derby, DE24 8HY,UK
GB
fixed
24.10.2023
Selectchemie AG
Etzelstrasse 42, 8038 Zürich
CH
Etzelstrasse 42, 8038 Zürich
CH
fixed
30.11.2023
AstraZeneca Pharmaceuticals LP
587 Old Baltimore Pike, Newark 19702
US
587 Old Baltimore Pike, Newark 19702
US
follow_up
03.08.2023
Welding GmbH & Co KG
Esplanade 39, 20354 Hamburg
DE
Esplanade 39, 20354 Hamburg
DE
fixed
06.10.2023
SYN-TECH CHEM. & PHARM. CO., LTD (Former Standard Chem. & Pharm. Co., Ltd.)
No.168 Kai Yuan Rd., Hsin Ying District,Tainan City 73055
TW
No.168 Kai Yuan Rd., Hsin Ying District,Tainan City 73055
TW
planned
Ausstehend
Misitano & Stracuzzi SPA
Via IV novembre, 261, 98023 Furci Siculo (ME)
IT
Via IV novembre, 261, 98023 Furci Siculo (ME)
IT
follow_up
24.05.2023
Alembic Pharmaceuticals Ltd
Alembic Road, Vadodara – 390 003
IN
Alembic Road, Vadodara – 390 003
IN
follow_up
23.06.2023
PHARMATHEN S.A. (Rodopi)
INDUSTRIAL PARK (BLOCK 5) SAPES RODOPI PIRAEUS 69300
GR
INDUSTRIAL PARK (BLOCK 5) SAPES RODOPI PIRAEUS 69300
GR
fixed
16.11.2023
Pharmathen International SA (Pallini Attikis)
4 Dervenakion Street, 15351 Pallini, Attica
GR
4 Dervenakion Street, 15351 Pallini, Attica
GR
fixed
14.11.2023
B. Braun Melsungen AG
Carl-Braun-Straße 1, 34212 Melsungen
DE
Carl-Braun-Straße 1, 34212 Melsungen
DE
scheduling
Ausstehend
trans-o-flex ThermoMed GmbH
Wolfsburger Str. 3, 34225 Baunatal
DE
Wolfsburger Str. 3, 34225 Baunatal
DE
fixed
17.10.2023
Dead Sea Periclase
Mishor Rotem Mobile Post Arava 8605
IL
Mishor Rotem Mobile Post Arava 8605
IL
planned
Ausstehend
Micro-Macinazione S.A.
Via Cantonale 4, Molinazzo di Monteggio, 6998
CH
Via Cantonale 4, Molinazzo di Monteggio, 6998
CH
planned
Ausstehend
Laborchemie Apolda GmbH
Utenbacher Straße 72-74 D - 99510 Apolda
DE
Utenbacher Straße 72-74 D - 99510 Apolda
DE
fixed
21.11.2023
EverZinc B.V.
Muggenweg 2, 6245 AB Eijsden
NL
Muggenweg 2, 6245 AB Eijsden
NL
planned
Ausstehend
Novacyl (SEQENS)
Plateforme Chimique, Rue Gaston Monmousseau, CS 50032, Lieu-dit le Roussillon 38556 Roussillon
FR
Plateforme Chimique, Rue Gaston Monmousseau, CS 50032, Lieu-dit le Roussillon 38556 Roussillon
FR
planned
Ausstehend
Finzelberg GmbH & Co. KG
Koblenzer Str. 48-56, 56626 Andernach
DE
Koblenzer Str. 48-56, 56626 Andernach
DE
fixed
29.11.2023
Wilhelm Bären Druck
Mittelstraße 62, D-41236 Mönchengladbach
DE
Mittelstraße 62, D-41236 Mönchengladbach
DE
planned
Ausstehend
Fachspedition Karl Dischinger GmbH
Karl-Dischinger-Str. 100 79238 Ehrenkirchen
DE
Karl-Dischinger-Str. 100 79238 Ehrenkirchen
DE
follow_up
19.07.2023
ERREGIERRE S.p.A. (Sovere)
via Valle delle Fontane, 2 24060 Sovere (BG)
IT
via Valle delle Fontane, 2 24060 Sovere (BG)
IT
planned
Ausstehend
ERREGIERRE S.p.A (San Paolo d'Argon)
via Francesco Baracca, 19 24060 San Paolo D'Argon (BG)
IT
via Francesco Baracca, 19 24060 San Paolo D'Argon (BG)
IT
planned
Ausstehend
canymed GmbH
Permoserstr. 19 04318 Leipzig
DE
Permoserstr. 19 04318 Leipzig
DE
planned
Ausstehend
EGIS Pharmaceuticals PLC
Mátyás király u. 65, HU-9900 Körmend
HU
Mátyás király u. 65, HU-9900 Körmend
HU
planned
Ausstehend
Hubei Biocause
No. 122 Yangwan Road, Jingmen City, Hubei Province
CN
No. 122 Yangwan Road, Jingmen City, Hubei Province
CN
planned
Ausstehend
Wiewelhove GmbH
Dörnebrink 19, 49479 Ibbenbüren
DE
Dörnebrink 19, 49479 Ibbenbüren
DE
planned
Ausstehend
Hovione Farma Ciencia S.A.
Sete Casas, 2674-506 Loures
PT
Sete Casas, 2674-506 Loures
PT
planned
Ausstehend
Dottikon Exclusive Synthesis AG
Hembrunnstraße 17, 5605 Dottikon
CH
Hembrunnstraße 17, 5605 Dottikon
CH
planned
Ausstehend
Arch Pharmalabs Ltd.
Manpada Road C-21/22 MIDC Phase II, Sagaon, Dombivli (East), Distinct Thane, Maharashtra
IN
Manpada Road C-21/22 MIDC Phase II, Sagaon, Dombivli (East), Distinct Thane, Maharashtra
IN
planned
Ausstehend
AqVida GmbH
Kaiser Wilhelm Straße 89, 20355 Hamburg
DE
Kaiser Wilhelm Straße 89, 20355 Hamburg
DE
planned
Ausstehend
Etiket Schiller GmbH
Heusee 14, 73655 Plüderhausen
DE
Heusee 14, 73655 Plüderhausen
DE
planned
Ausstehend
Atul Ltd.
Pharmaceuticals & Intermediates Division, Atul 396 020, Gujarat
IN
Pharmaceuticals & Intermediates Division, Atul 396 020, Gujarat
IN
follow_up
20.07.2023
ANUH Pharma Ltd.
E-17/3 & E17/4 M.I.D.C. Tarapur, Taluka Palghar, District Thane, BOISAR, Maharashtra, 401506
IN
E-17/3 & E17/4 M.I.D.C. Tarapur, Taluka Palghar, District Thane, BOISAR, Maharashtra, 401506
IN
follow_up
21.08.2023
AMSAL Chem. Private Limited
Amsal Chem Private Limited, A-1, 401, 402 & 403, G.I.D.C. industrial Estate, Ankleshwar-393 002, District: Bharuch, Gujarat
IN
Amsal Chem Private Limited, A-1, 401, 402 & 403, G.I.D.C. industrial Estate, Ankleshwar-393 002, District: Bharuch, Gujarat
IN
planned
Ausstehend
Sauerstoffwerk Friedrichshafen GmbH
Colsmanstraße 11, 88045 Friedrichshafen
DE
Colsmanstraße 11, 88045 Friedrichshafen
DE
planned
Ausstehend
Phaex Polymers Pvt. Ltd.
Plot F 10, MIDC, Murbad
Taluka Murbad, Thane,
Maharashtra, Mumbai-421401
IN
Plot F 10, MIDC, Murbad
Taluka Murbad, Thane,
Maharashtra, Mumbai-421401
IN
planned
Ausstehend
DMV Fonterra Excipients GmbH & Co.
Lauenförderer Straße 5, 37176 Nörten-Hardenberg
DE
Lauenförderer Straße 5, 37176 Nörten-Hardenberg
DE
planned
Ausstehend
Daikyo Seiko Ltd.
West Daikyo, Sano Haneda Plant 1 and 2, 2015, Shimohaneda-Cho, Sano-Shi, Tochigi 327-0044
JP
West Daikyo, Sano Haneda Plant 1 and 2, 2015, Shimohaneda-Cho, Sano-Shi, Tochigi 327-0044
JP
planned
Ausstehend
Hofmann & Sommer GmbH u. Co. KG
Lindenstraße 11 07426 Königsee-Rottenbach
DE
Lindenstraße 11 07426 Königsee-Rottenbach
DE
scheduling
Ausstehend
Wagener & Co.
Lohesch 60, 49525 Lengerich
DE
Lohesch 60, 49525 Lengerich
DE
fixed
07.12.2023
Zaklady Farmaceutyczne POLPHARMA S.A
Pelplinska Str. 19, 83-200 Starogard Gdanski
PL
Pelplinska Str. 19, 83-200 Starogard Gdanski
PL
planned
Ausstehend
Pharmakina S.A.
Km4, Goma Road 1240 Bukavu
CD
Km4, Goma Road 1240 Bukavu
CD
planned
Ausstehend
BAG Healthcare GmbH
Amtsgerichtsstrasse 1-5, 35423 Lich
DE
Amtsgerichtsstrasse 1-5, 35423 Lich
DE
follow_up
21.02.2023
Hubert De Backer nv/ HDB
Laagstraat 59, 9140 Temse
BE
Laagstraat 59, 9140 Temse
BE
planned
Ausstehend
Gerresheimer Moulded Glass GmbH
Rodenbacher Str. 38, 97816 Lohr
DE
Rodenbacher Str. 38, 97816 Lohr
DE
planned
Ausstehend
Tentamus Pharma & Med Deutschland GmbH ( fromer BLS-Analytik GmbH & Co. KG)
Columbiastrasse 14, 97688 Bad Kissingen
DE
Columbiastrasse 14, 97688 Bad Kissingen
DE
planned
Ausstehend
GUFIC LIFESCIENCES PRIVATE LIMITED
SURVEY NO - 171, NATIONAL HIGHWAY NO 8 NEAR GRID. AT & PO KABILPORE GUJRAT. 396 424 - NAVSARI
IN
SURVEY NO - 171, NATIONAL HIGHWAY NO 8 NEAR GRID. AT & PO KABILPORE GUJRAT. 396 424 - NAVSARI
IN
planned
Ausstehend
MEDREICH LIMITED (Unit-VII)
UNIT VII: SURVEY NO. 11, 12, 13, 14 AND 15, POOJARAMANAHALLI VILLAGE, BENGALURU RURAL DISTRICT, KARNATAKA 562114
IN
UNIT VII: SURVEY NO. 11, 12, 13, 14 AND 15, POOJARAMANAHALLI VILLAGE, BENGALURU RURAL DISTRICT, KARNATAKA 562114
IN
planned
Ausstehend
MEDREICH LIMITED (Unit-I)
UNIT I: 12TH MILE, OLD MADRAS ROAD, VIRGONAGAR POST, BENGALURU, 560 049
IN
UNIT I: 12TH MILE, OLD MADRAS ROAD, VIRGONAGAR POST, BENGALURU, 560 049
IN
planned
Ausstehend
IPCA LABORATORIES LTD. (MANUFACTURING SITE OF SILVASSA)
PLOT NO. 255/1, VILLAGE ATHAL, UNION TERRITORY OF DADRA & NAGAR HAVELI, 396 230 SILVASSA
IN
PLOT NO. 255/1, VILLAGE ATHAL, UNION TERRITORY OF DADRA & NAGAR HAVELI, 396 230 SILVASSA
IN
follow_up
26.05.2023
Particle Dynamics LLC
2223 Killion Avenue, Seymour, IN 47274
US
2223 Killion Avenue, Seymour, IN 47274
US
planned
Ausstehend
Roquette Freres
Lestrem, 62136
FR
Lestrem, 62136
FR
planned
Ausstehend
transmed Transport GmbH
Am Schenkberg 3, 04349 Leipzig
DE
Am Schenkberg 3, 04349 Leipzig
DE
planned
Ausstehend
SANOFI CHIMIE
Route d’Avignon , France-30390 Aramon
FR
Route d’Avignon , France-30390 Aramon
FR
planned
Ausstehend
Portocanna
R. dos Comerciantes de Carnes, 2005-002
PT
R. dos Comerciantes de Carnes, 2005-002
PT
planned
Ausstehend
Symtomax
Rua dos Marceneiros N.º 2, 7800-009 Beja
PT
Rua dos Marceneiros N.º 2, 7800-009 Beja
PT
planned
Ausstehend
Binhai Sanyong Pharmaceutical Chemical CO., LTD.
Touzeng Village, Yanhai Chemical Industrial Park
Binhai County, Yancheng City
224 555 Binhuai, Jiangsu Province
CN
Touzeng Village, Yanhai Chemical Industrial Park
Binhai County, Yancheng City
224 555 Binhuai, Jiangsu Province
CN
planned
Ausstehend
Benechim S.R.L.
Rue René Magritte, 163
7860 Lessines
BE
Rue René Magritte, 163
7860 Lessines
BE
planned
Ausstehend
Harman Finochem Ltd.
Plot.no.E9, MIDC Industrial Area, Chilkalthana, Aurangabad, Maharashtra 431006
IN
Plot.no.E9, MIDC Industrial Area, Chilkalthana, Aurangabad, Maharashtra 431006
IN
planned
Ausstehend
Harman Finochem Ltd.
Plot.no.E9, MIDC Industrial Area, Chilkalthana, Aurangabad, Maharashtra 431006
IN
Plot.no.E9, MIDC Industrial Area, Chilkalthana, Aurangabad, Maharashtra 431006
IN
planned
Ausstehend
Dishman Pharmaceuticals and Chemicals Limited (Naroda)
4M2J+F53, GIDC Naroda, Ahmedabad, Gujarat 382330
IN
4M2J+F53, GIDC Naroda, Ahmedabad, Gujarat 382330
IN
planned
Ausstehend
Glenmark
Plot No.3109, G.I.D.C. Industrial Estate Bharuch District. India-393 002 Ankleshwar, Gujarat
IN
Plot No.3109, G.I.D.C. Industrial Estate Bharuch District. India-393 002 Ankleshwar, Gujarat
IN
planned
Ausstehend
IOL CHEMICALS AND PHARMACEUTICALS LTD
Village Fatehgarh Channa Mansa Road ( Trident Complex) Barnala, Punjab 148 101
IN
Village Fatehgarh Channa Mansa Road ( Trident Complex) Barnala, Punjab 148 101
IN
planned
Ausstehend
Granules India Limited
Survey No. 160/A, 161/E, 162 & 174/A, Gagillapur Village, Dundigal-Gandimaisamma Mandal, Medchal-Malkajgiri District, Telangana - 500043
IN
Survey No. 160/A, 161/E, 162 & 174/A, Gagillapur Village, Dundigal-Gandimaisamma Mandal, Medchal-Malkajgiri District, Telangana - 500043
IN
planned
Ausstehend
Hetero Drugs Limited
Survey No. 213, 214 & 255, Jinnaram Mandal, Medak District, India - 502 313 Bonthapally Village, Telangana, Andhra Pradesh
IN
Survey No. 213, 214 & 255, Jinnaram Mandal, Medak District, India - 502 313 Bonthapally Village, Telangana, Andhra Pradesh
IN
planned
Ausstehend
Torrent
Ahmedabad, Mehsana Highway, Taluka Kadi, District Mehsana, India - 382 721 Indrad, Gujarat
IN
Ahmedabad, Mehsana Highway, Taluka Kadi, District Mehsana, India - 382 721 Indrad, Gujarat
IN
planned
Ausstehend
Ercros S.A.
Paseo del Deleite, s/n
28300 Aranjuez, Madrid
ES
Paseo del Deleite, s/n
28300 Aranjuez, Madrid
ES
planned
Ausstehend
trans-o-flex Express GmbH & Co. KGaA
Daimlerstraße 1, 90592 Schwarzenbruck
DE
Daimlerstraße 1, 90592 Schwarzenbruck
DE
fixed
18.10.2023
H. Essers Transport Company Germany GmbH
Siemensstr. 44
67227 Frankenthal
DE
Siemensstr. 44
67227 Frankenthal
DE
planned
Ausstehend
Sharp Corporation
7451 Keebler Way, 18106 Allentown, Pennsylvania
US
7451 Keebler Way, 18106 Allentown, Pennsylvania
US
follow_up
18.08.2022
Dipharma Francis S.R.L. (Mereto di Tomba)
Via XXIV Maggio 40, 33036 Mereto di Tomba, Italy
IT
Via XXIV Maggio 40, 33036 Mereto di Tomba, Italy
IT
planned
Ausstehend
Sanofi Chimie, Société anonyme
32 Rue de Verdun, 76410 St.-Aubin-lès-Elbeuf
FR
32 Rue de Verdun, 76410 St.-Aubin-lès-Elbeuf
FR
planned
Ausstehend
Pharmasynthèse SA
57 Rue Gravetel, 76320 Saint-Pierre-lès-Elbeuf
FR
57 Rue Gravetel, 76320 Saint-Pierre-lès-Elbeuf
FR
planned
Ausstehend
Labor LS SE & Co. KG
Mangelsfeld 4, 5, 6, 97708 Bad Bocklet-Großenbrach
DE
Mangelsfeld 4, 5, 6, 97708 Bad Bocklet-Großenbrach
DE
planned
Ausstehend
Hikma Thymoorgan Pharmazie GmbH
Schiffgraben 23, 38690 Vienenburg, Germany
Schiffgraben 23, 38690 Vienenburg, Germany
planned
Ausstehend
DSM Nutritional Products AG
Hauptstrasse 4, 4334 Sisseln
CH
Hauptstrasse 4, 4334 Sisseln
CH
planned
Ausstehend
TEVA API B.V. (TEVA CZECH)
Opava, Komárov
CZ
Opava, Komárov
CZ
planned
Ausstehend
Tereos Alcools Origny (SDA Brabant)
11 Rue Pasteur, 02390 Origny-Sainte-Benoite
FR
11 Rue Pasteur, 02390 Origny-Sainte-Benoite
FR
planned
Ausstehend
ST Pharm Co., Ltd.
Ban-Wol Plant, 171 Haean-ro, Danwon-gu, Ansan-si, Gyeonngi-do
KR
Ban-Wol Plant, 171 Haean-ro, Danwon-gu, Ansan-si, Gyeonngi-do
KR
planned
Ausstehend
Shandong Anhong Pharmaceutical Co., Ltd.
No. 29 Huayuan Street Linyi County, Dezhou, Shandong
CN
No. 29 Huayuan Street Linyi County, Dezhou, Shandong
CN
planned
Ausstehend
Salus-Haus Dr. med. Otto Greither Nachf. GmbH & Co. KG
Bahnhofstr. 24, 83052 Bruckmühl
DE
Bahnhofstr. 24, 83052 Bruckmühl
DE
planned
Ausstehend
Purac Bioquimica
Gran Vial 19-25, 08160 Montmelo (Barcelona)
ES
Gran Vial 19-25, 08160 Montmelo (Barcelona)
ES
planned
Ausstehend
Pharma-Zentrale GmbH
Loerfeldstraße 20, 58313 Herdecke
DE
Loerfeldstraße 20, 58313 Herdecke
DE
planned
Ausstehend
Patheon Austria GmbH & Co KG
Sankt-Peter-Straße 25, 4020 Linz
AT
Sankt-Peter-Straße 25, 4020 Linz
AT
planned
Ausstehend
Nordmark Arzneimittel GmbH & Co KG
Pinnauallee 4, 25436 Uetersen
DE
Pinnauallee 4, 25436 Uetersen
DE
planned
Ausstehend
Martin Bauer GmbH &CO. KG
Bahnhofstraße 2, 25486 Alvelslohe
DE
Bahnhofstraße 2, 25486 Alvelslohe
DE
planned
Ausstehend
Grillo Zinkoxid GmbH
Halberstädter Str. 15, 38644 Goslar
DE
Halberstädter Str. 15, 38644 Goslar
DE
planned
Ausstehend
Gerresheimer Wertheim GmbH
Dertinger Weg 1, 97877 Wertheim
DE
Dertinger Weg 1, 97877 Wertheim
DE
planned
Ausstehend
Gerresheimer Moulded Glass GmbH
Tettaugrundstraße 1-5, 96355 Tettau
DE
Tettaugrundstraße 1-5, 96355 Tettau
DE
planned
Ausstehend
Farmhispania S.A.
Passeig del Riu Besós 9-10, 08160 Montmeló
ES
Passeig del Riu Besós 9-10, 08160 Montmeló
ES
fixed
20.03.2024
Cytec Industries Inc., Willow Island Plant
1 Heilman Avenue, West Virginia 26134
US
1 Heilman Avenue, West Virginia 26134
US
planned
Ausstehend
ARORA AROMATICS PVT. LTD.
2 Km Stone, Moradabad Rd, Uttar Pradesh 244302
IN
2 Km Stone, Moradabad Rd, Uttar Pradesh 244302
IN
planned
Ausstehend
Arkema GmbH NL Kirchheimbolanden
Morschheimer Str. 19, 67292 Kirchheimbolanden
DE
Morschheimer Str. 19, 67292 Kirchheimbolanden
DE
planned
Ausstehend
Anqiu Lu´an Pharmaceutical Co., Ltd.
No. 35 Weixu North Road, 262 100 Anqiu City, Shadong Province
CN
No. 35 Weixu North Road, 262 100 Anqiu City, Shadong Province
CN
planned
Ausstehend
AMRI Italy S.r.l.,
Via Volturno 41-43, 20089 Rozzano, Mailand
IT
Via Volturno 41-43, 20089 Rozzano, Mailand
IT
planned
Ausstehend
Case Study
Use case: GxP audits worldwide
Our customers include, among others
- Cheplapharm Arzneimittel GmbH
- CP-Pharma Handelsgesellschaft mbH
- Esteve Pharmaceuticals GmbH
- EVER Pharma Jena GmbH
- InfectoPharm Arzneimittel und Consilium GmbH
- Krewel meuselbach GmbH
- Labatec Pharma SA
- L-A-W Services GmbH Leipziger Arzneimittelwerk
- mibe GmbH Pharmaceuticals
- Pharma Greven GmbH
- Takeda Pharma Vertrieb GmbH & Co. KG
Audits carried out
> 1.500
Worldwide audits
> 40 countries
Satisfied customers
> 200
Our audit specialists
Get to know us.
Dr. Dieter Bloß
Head of APM Board
Dr. Bloß holds a doctorate in chemistry and can look back on a long career in the pharmaceutical industry.
At G.Pohl Boskamp, he held positions such as Head of Quality Control, Vice President Scientific Affairs, Senior Director Quality Control and 10 years as a Qualified Person before retiring in 2015.
Today, Dr. Bloß is dedicated to the QM system of the Audit Management business unit at Heacon Service GmbH.
Dr. Bernd Hasken
Head of APM + APM Board Member
Dr. Hasken has successfully managed the audit program since 2015.
As a doctor of chemistry and trained auditor, he co-founded and established the Shared Audit Program and the APM Board in its current form.
In addition to managing the audit program, he also works as an auditor worldwide.
Dr. Marcus Niehörster
APM Board Member
Dr. Niehörster has been working worldwide as an auditor, expert and consultant for authorities and pharmaceutical companies for over 25 years.
He worked for over 20 years as a consultant, auditor and trainer for PCS GmbH in the role of managing director.
He is professionally qualified as a Senior GMP Compliance Expert and as a Senior GMP Auditor and has been a GMP Technical Expert of the Swiss Accreditation Service SAS for 15 years.
