All excipient production sites with GMP certification

In the pharmaceutical world, the term GMP, or Good Manufacturing Practice, plays quite a big role. In this article, we explain what GMP stands for in general, and specifically for the pharmaceutical excipient industry. Moreover, it is shown which organizations perform testing and inspection, and how the GMP-certification process works. To get a good overview of the currently GMP-certified excipient production sites,we have marked all of them in an interactive mapwith additional information available.

What is GMP exactly?

“Good manufacturing practices(GMP)是为了符合t所需的实践活动o the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. […] The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over 100 countries worldwide, primarily in the developing world. The European Union’s GMP (EU-GMP) enforces similar requirements to WHO GMP, as does the FDA’s version in the US. Similar GMPs are used in other countries, with Australia, Canada, Japan, Saudi Arabia, Singapore, Philippines, Vietnam and others having highly developed/sophisticated GMP requirements.” (Wikipedia)

In the excipient industry,EXCiPACThas an important role:

Regulators require excipient users to qualify their suppliers based on GMP/GDP audits and they have indicated that third party auditing of suppliers is acceptable if a creditable certification body issues certificates and audit reports by employing qualified auditors who are demonstrably credible in suitable GMP/GDP standards and in the needs of the pharmaceutical industry.EXCiPACT asbl is a non-profit organisation that owns and manages oversight of such an independent, high quality, third party Certification Scheme available to pharmaceutical excipient manufacturers and distributors worldwide.

Which certification bodies are working with EXCiPACT?

There are several certification bodies working with EXCiPACT, these are: SGS (global); AENOR (global); AJA (global), blue inspection body (global), DQS (mainly Europe and Mid-East); BV (mainly China), and Certiquality (mainly Italy).

The Certification Scheme can only be undertaken by a Registered EXCiPACT Certification Body employing a Registered EXCiPACT Auditor. The Certification process contains eigth steps in total.

Certification Scheme EXCiPACT
EXCiPACT GMP Certification Process

This is the first step:

“The Supplier selects a Certification Body from the approved list and provides them with information to issue a cost quotation, audit timetable and duration for a 3-year certification audit. This reflects the supplier’s audit scope and the organisational and operational complexity of the specified site.”

The remaining steps of the certification process can be seen hereor in the graphic on the right side, which can be expanded.

The detailed process may vary with each Registered EXCiPACT Certification Body.

Developed by excipient suppliers and users, the Scheme’s core objectives are (i) to demonstrate a safe, reliable, transparent pharmaceutical supply chain, and (ii) to reduce the audit burden, costs and resources for manufacturers, distributors and users of pharmaceutical excipients without compromising quality. The Scheme comprises the following components:

  1. GMP standard for excipients as an annex to ISO 9001:2015
  2. GDP standard for excipients as an annex to ISO 9001:2015
  3. Certifying Body competency qualification as an annex to ISO 17021-1:2015
  4. Auditor competency qualification as an annex to ISO 17021-1:2015.

Have a look at all the pharmaceutical excipient production sites with EXCiPACT Certification here:

See the GMP-certified production site’s of our partners:

Name Certification Body Site Location Scope Issue Date Expiry Date Registration Number Certified Since
Air Liquide Austria GmbH AJA (Global) Schwechat, Austria GDP, GMP 19. Nov 19 19. Nov 22 AJAEU/20/009 19. Nov 19
Air Liquide Benelux Industries DQS GmbH Marchienne-au-Pont, Belgium GDP, GMP 02. Aug 19 01. Aug 22 527184 EXCI 02. Aug 16
Air Liquide France Industrie Grande Synthe SGS Grande-Synthe, France GMP 12 January, 2021 11 January, 2024 FR17/81842681 12 January, 2018
Air Liquide France Industrie Moissy Cramayel SGS Moissy Cramayel, France GMP 12 January, 2021 11 January, 2024 FR17/81842665 12 January, 2018
Air Liquide France Industrie, Feyzin Activité Liquide SGS Feyzin, France GMP 12 January, 2021 11 January, 2024 FR17/81842646 12 January, 2018
Air Liquide Italia Produzione srl Certiquality Castelnuovo del Garda, Verona, Italy GMP 11 December, 2020 10 December, 2023 P4513 11 December, 2020
Air Liquide Italia Produzione srl Certiquality Limito Di Piotello, Milan, Italy GMP 19. Nov 20 18. Nov 20 P4485 19. Nov 20
Air Liquide Italia Service SRL Certiquality Rodano (Milano), Italy GMP 25. Aug 20 24. Aug 20 P4452 25. Aug 20
AL Air Liquide España, S.A. AENOR Cabanillas del Campo (Guadalajara), Spain GDP, GMP 16. Sep 20 16. Sep 23 EXC-2020/001 16. Sep 20
AL Air Liquide España, S.A. AENOR Madrid, Spain GDP, GMP 16. Sep 20 16.09.2020 EXC 2020/002 16. Sep 20
Armor Proteines S.A.S. (ARMOR PHARMA™) SGS Loudéac, France GMP 08. Aug 19 07. Aug 22 FR16/1842321 08. Aug 19
BASF Advanced Chemicals Co., Ltd Bureau Veritas China Pudong, Shanghai, PR China GMP 05 March, 2020 04 March, 2023 CNBJ202001 05 March, 2020
BIOGRUND GmbH DQS GmbH Hünstetten, Germany GDP, GMP 26 June, 2019 25 June, 2022 296948 EXCI 13 December, 2013
Chemische Fabrik Budenheim KG SGS Budenheim, Germany GDP, GMP 14. Apr 20 13. Apr 23 DE16/819942543 19 June, 2014
Evonik Nutrition & Care GmbH DQS GmbH Darmstadt, Weiterstadt, Germany GDP, GMP 08 January, 2020 07 January, 2023 527392 EXCI 27 January, 2014
Ideal Cures Private Limited SGS Jammu, Jammu & Kashmir, India GMP 12 February, 2021 04 February, 2024 IN/EXCiPACT/15/50053 06 February, 2015
Ideal Cures Private Limited SGS Vasai (East), Palghar, India GMP 27. Apr 18 26. Apr 21 IN/EXCiPACT/15/50060 27. Apr 15
JRS Pharma SGS Cedar Rapids, Iowa, USA GMP 27. Aug 19 26. Aug 22 US19/819943331 27. Aug 19
JRS Pharma & Gujarat Microwax Private Limited SGS Nandasan, India GMP 19. Aug 18 18. Aug 21 IN18/500165 19. Aug 18
JRS Pharma & Gujarat Microwax Private Limited SGS Nandasan, India GMP 19. Aug 18 18. Aug 21 IN18/500165.01 19. Aug 19
JRS Pharma and Gujarat Microwax Pvt. Ltd. (Unit - IV) SGS Mehsana, Gujarat, India GMP 17 December, 2020 17 December, 2023 IN20/818844536 17 December, 2020
JRS Pharma Oy AJA (Global) Nastola, Finland GMP 27 January, 2020 27 January, 2023 AJAEU/15850 27 January, 2020
MEGGLE GmbH & Co. Kg SGS Wasserburg, Germany GDP, GMP 01 July, 2020 30 June, 2023 DE17/819943082 27 July, 2014
Merck KGaA blue inspection body Darmstadt, Germany GDP, GMP 17 June, 2019 17 June, 2022 E-ME-18887-2019-01 25 June, 2013
Merck Life Science Technologies (Nantong) Co., Ltd. Bureau Veritas China Nantong, Jiangsu, PR China GMP 30 June, 2020 29 June, 2023 CNSH7682741 30 June, 2020
Microcellulose Weissenborn GmbH & Co KG DQS GmbH Weissenborn/Erzgebirge, Germany GDP, GMP 15 January, 2019 14 January, 2022 537607 EXCI 15 January, 2019
Nutrition & Biosciences USA 1 LLC Midland Ethocel Operations SGS Midland, Michigan, USA GMP 07 January, 2018 06 January, 2021 US18/81827258 07 January, 2018
Nutrition & Biosciences USA 1 LLC Midland Methocel Operations SGS Midland, Michigan, USA GMP 2018年1月,08年 07 January, 2021 US18/81827257 2018年1月,08年
Nutrition & Biosciences USA 1, LLC LA Methocel Operations SGS Plaquemine, Louisiana, United States GMP 26 June, 2018 25 June, 2021 US18/81827450 26 June, 2018
Omya SAS Bureau Veritas China Orgon, France GMP 23 January, 2019 22 January, 2022 CNSH10344096 01 January, 1970
Rettenmaier Iberica SL y Cia S.C AENOR Barcelona, Spain GDP 12 January, 2021 12 January, 2024 EXC 2021/001 12 January, 2021
Rettenmaier Natural Fiber Manufacturing (Changzhou) Co., Ltd. Bureau Veritas China Changzou, PR China GMP 17 July, 2020 16 July, 2023 CNSH6866459 17 July, 2020
ROQUETTE FRERES SGS Lestrem, France GMP 24 December, 2018 23 December, 2021 FR15/81841993 24 December, 2015
SEPPIC SGS Castres, France GMP 04. Sep 18 03. Sep 21 FR16/81842387 22. Nov 13
SEPPIC (Shanghai) Chemical Specialities Co., Ltd SGS Shanghai, China GMP 24 July, 2019 23 July, 2022 CN16/21698 22. Nov 16
Specialty Products US, LLC SGS Institute, West Virginia, USA GMP 07 January, 2018 06 January, 2021 US18/81827245 07 January, 2018

Sources:Wikipedia,EXCiPACT,EXCiPACT 2