Audits
17.01.2022 By correspondence, application form JSC Pharmstandard-Leksredstva
18.01.2022 Remote JSC "Pharmstandard-Leksredstva"
15.02.2022 Full-time Valenta Pharm JSC
18.02.2022 Full-time LLC "Groteks"
24.02.2022 By correspondence, application form Chimpharm JSC (Santo)
02.03.2022 By correspondence, application form Pharmaceutical company MEDISORB
10.03.2022 By correspondence, application form PJSC Sintez
31.03.2022 By correspondence, application form JSC "Vertex"
19.01.2021 By correspondence, application form OJSC "Irbitsky Chemical Pharmaceutical"
01.02.2021 By correspondence, application form LLC "Groteks"
12.02.2021 By correspondence, application form JSC "Vertex"
March 2021 Remote CJSC "PharmFirm "Sotex"
16.03.2021 Full-time LLC "Groteks"
18.03.2021 Full-time PJSC "Biosintez"
19.03.2021 Full-time LLC "PHARMACOR PRODUCTION"
23.03.2021 Full-time CJSC "Evalar"
24.03.2021 Full-time OJSC "Pharmstandard-Leksredstva"
26.03.2021 Full-time JSC "Akrikhin"
02.07.2021 By correspondence, application form JSC "Valenta Pharm"
04.10.2021 By correspondence, application form ABBA RUS
29.10.2021 By correspondence, application form Pharmaceutical company "Northern Star"
16.11.2021 Remote STADA (Nizhpharm JSC)
19.11.2021 Full-time NJSC "Northern Star"
19.11.2021 By correspondence, application form Alium JSC
23.11.2021 Full-time LLC "NTFF "POLYSAN"
25.11.2021 Remote JSC "Irbitsky chemical pharmaceutical"
30.11.2021 By correspondence, application form JSC Akrikhin
07.12.2021 By correspondence, application form Hemofarm A.D.
20.12.2021 By correspondence, application form NIKA pharmaceuticals
December 2021 By correspondence, application form OJSC Pharmstandard-Leksredstva
03.12.20 | By correspondence, application form | I | Biochemist JSC |
28.07.20 | By correspondence, application form | I | ECOlab JSC |
13.07.20 | By correspondence, application form | I | Pharmastandard-Leksredstva JSC |
04.12.20 | By correspondence, application form | II | STADA LLC |
22.06.20, 30.12.20 | By correspondence, application form | I, II | Pharmakor Production LLC |
03.06.20, 15.06.20 | Remote | I, II | Ministry of Industry and Trade of the Russian Federation |
20.05.20 | By correspondence, application form | I | STS Pharma |
23.12.2019 | Face-to-face | I, II | Ministry of Industry and Trade of the Russian Federation |
27.11.2019 | By correspondence, application form | I | Pharmstandard JSC |
18.02.2019 | By correspondence, application form | I | Valenta Pharm JSC |
13.06.2019 | By correspondence, application form | I | Pharmaceutical company Obnovlenie JSC |
28.08.2019 | By correspondence, application form | I | VIPS-MED Firm LLC |
04.09.2019 | By correspondence, application form | I | Grotex LLC |
18.10.2019 | By correspondence, application form | I | STADA LLC |
18.10.2019 | By correspondence, application form | I | Irbitskiy Khimpharmzavod JSC |
06.11.2019 | By correspondence, application form | I | OTISIPHARM JSC |
12.01.2018
Audit passed: STADA LLC
Form: Desk, questionnaire
01.02.18
Audit passed: Ministry of Industry and Trade of Russia
Form: Full time
Auditors:
N.N. Aladysheva – Leading Advisor of the Drug Production Licensing & Inspection Unit of the Pharmaceutical and Medical Industry Development Department
A.V. Reznichenko – Deputy Head of the Drug Production Licensing & Inspection Unit of the Pharmaceutical and Medical Industry Development Department
11.04.18
Audit passed: Severnaya Zvezda CJSC
Form: Full time
Auditors:
M.V. Dubko – Authorized person
U.Y. Yuplova – Quality Director
E.V. Vasilyeva – Head of Quality Control Department
11.05.18
Ya.B. Maryasova – Quality Compliance Specialist
24.05.18
Audit passed: Pharmproject JSC
Form: Full time
Auditors:
N.A. Korosteleva – Head of Quality Control Department
T.V. Shavrina – Head of Supply Department
07.05.18
Audit passed: Pharmproject JSC
Form: Desk, questionnaire
29.05.18
Audit passed: Valenta Pharm JSC
Form: Desk, questionnaire
09.08.18
Audit passed: Novosibkhimpharm JSC
Form: Desk, questionnaire
22.08.18
Audit passed: Pharmfirma Soteks CJSC
Form: Desk, questionnaire
31.08.18
Audit passed: Biosyntez PJSC
Form: Full time
05.09.18
Audit passed: Groteks LLC
Form: Desk, questionnaire
05.09.18
Audit passed: Groteks LLC
Form: Desk, questionnaire
V.A. Grebenik – Chief Process Engineer
07.05.18
Audit passed: Pharmproject JSC
Form: Desk, questionnaire
29.05.18
Audit passed: Valenta Pharm JSC
Form: Desk, questionnaire
09.08.18
Audit passed: Novosibkhimpharm JSC
Form: Desk, questionnaire
22.08.18
Audit passed: Pharmfirma Soteks CJSC
Form: Desk, questionnaire
31.08.18
Audit passed: Biosyntez PJSC
Form: Full time
05.09.18
Audit passed: Groteks LLC
Form: Desk, questionnaire
05.09.18
Audit passed: Groteks LLC
Form: Desk, questionnaire
March 2017
Audit passed: Firma VIPS-Med LLC
Form: Desk, questionnaire
April 2017
Audit passed: ООО «TEVA»
Form: Desk, questionnaire
20.09.17-21.09.17
Audit passed: STADA LLC
Form: Full time
Auditors:
I.I. Nakhimova – Senior Audit Manager of DK Nizhpharm JSC
O.I. Sedova – Head of QA for DK Nizhpharm JSC
A.A. Pulkina – QA Leading Process Engineer for DK Nizhpharm JSC
03.10.2017
Form: Full time Auditors:
S.V. Ushakova – Chief Quality Assurance Specialist
E.I. Konovalova – Standardization Specialist
17.10.2017
Audit passed: FP Obolenskoye JSC
Form: Full time
Auditors:
N.A. Gabitova – Quality Director
D.S. Yatsyuk – Head of Quality Assurance Department
A.S. Karpova – QA Manager
14.11.2017
Audit passed: Vertex LLC
Form: Full time
Auditors:
E.G. Karaseva – Director of Quality Management
I.E. Degtyareva – Quality Engineer of the Quality Management Department
D.N. Chebotareva – Head of the Commercial Group of the Supply Department
Audit passed: Valenta Pharm JSC
Form: Desk, questionnaire
December 2016
Audit passed: Nizhpharm OJSC
Form: Desk, questionnaire
August 2016
Audit passed: Biosyntez OJSC
Form: Desk, questionnaire
July 2016
Audit passed: Biomedical complex Nanolek
Form: Desk, questionnaire
June 2016
Form: Desk, questionnaire
June 2016
Audit passed: Moscow Pharmaceutical Factory CJSC
Form: Desk, questionnaire
27.05.2016
Audit passed: Severnaya Zvezda CJSC
Form: Full time
April 2017
Audit passed: Nizhpharm OJSC
Form: Desk, questionnaire
April 2017
Audit passed: Akrikhin OJSC
Form: Desk, questionnaire
April 2017
Audit passed: Pharmaceutical company Medisorb
Form: Desk, questionnaire
30.11.15-01.12.15
Audit passed: Canonpharma Production CJSC
Form: Full time
September 2015
Audit passed: Valenta Pharmacevtika OJSC
Form: Desk, questionnaire
August 2016
Audit passed: Sintez OJSC
Form: Desk, questionnaire
August 2015
Form: Desk, questionnaire
August 2015
Audit passed: FP Obolenskoye СJSC
Form: Desk, questionnaire
27.05.2016
Audit passed: Evalar CJSC
Form: Desk, questionnaire
19.02.2015
Audit passed: Ministry of Industry and Trade of Russia
Form: Planned field inspection
17.02.2015
Audit passed: Federal Health Surveillance Service
Form: Planned field inspection
November 2014
Audit passed: Stada CIS LLC
Form: Desk, questionnaire
24.11.2014
Audit passed: AVVA RUS OJSC
Form: Full time
June 2014
Audit passed: Vertex LLC
Form: Desk, questionnaire
June 2014
Form: Desk, questionnaire
03.05.2014-05.06.2014 год
Audit passed: Stada CIS LLC
Form: Full time
May 2014
Form: Desk, questionnaire
May 2014
Form: Desk, questionnaire
26.05.2014-27.05.2014
Audit passed: Severnaya Zvezda CJSC
Form: Full time
April 2014
Form: Desk, questionnaire
January 2014
Form: Desk, questionnaire
Audit passed: Vertex CJSC
07.08.2013
Auditors:
E.G. Karaseva – Director of Quality Management
M.V. Berezina – Head of Quality Management Department
D.N. Chebotareva – Head of the Commercial Group
________________________________________
Audit passed: Veropharm OJSC
22-23.07.2013
Auditors:
G.A. Afonina – senior chemist for the quality control department of VEROFARM OJSC branch in Belgorod.
L.V. Kostrykina – specialist (complaint management in the field of quality assurance) of VEROFARM OJSC branch in Belgorod.
________________________________________
Audit passed: AKRIKHIN OJSC (verification of corrective actions)
08.07.2013
Auditors:
M.N. Lavrova – Quality Director
E.A. Shemyakina – Supplier Qualification Manager
________________________________________
Audit passed: Organika OJSC
06.06.2013
Auditors:
T.Y. Zanina – Head of Quality Assurance Department at Organika OJSC
I.M. Titova – Deputy Head of Procurement Department, Organika OJSC December 2012
December 2012
Audit passed: Akrikhin OJSC
19.04.2011
Audit passed: Stada CIS LLC
Auditors:
N.A Novichkova – Head of Quality Assurance Department, Stada CIS LLC, Moscow, Russia
T.V. Hayetskaya – Senior Quality Manager of Quality Assurance Department, Stada CIS LLC,
Moscow, Russia
N.Y. Guschina – Quality Manager of Quality Assurance Department, Stada CIS LLC, Nizhny
Novgorod, Russia
Opinions and Observations on the Audit of ACTICOMP LLC by Stada CIS LLC Group of Companies:
The organization of production, assurance and quality control system meet the requirements of EU GMP. The company employs experienced and competent employees. The quality system is described in standard operating procedures, the documentation is GMP compliant. The laboratories are well equipped and have enough space to avoid cross-flows.
16-17.07.2009
Audit passed: Valenta Pharmacevtika OJSC
Chief Auditor: A.S. Arutyunova – Quality Assurance Manager
Auditors: A.N. Babikov – Head of the Quality Control and Assurance Department
________________________________________
20.05.2009
Audit passed: Canonpharma Production CJSC
Auditors: G.E. Baryshnikova – Director for Strategic Development
N.S. Vetrova – Quality Director
I.A. Gert – Head of QA
18.12.2008
Audited by Makiz-Pharma CJSC
Auditors: N.A. Novichkova – Deputy Director of Quality Management Department
L. N. Pavlyuchenkova – Head of Production Department
________________________________________
18-19.11.2008
The audit of the company JSC "Akrikhin" has been passed
Auditors: N.A. Novichkova – Deputy Director of Quality Management Department
Audit team members: L.V. Rozhkovskaya – Head of Documentation and Audit Unit of the Quality Assurance Department