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TUEV ISO CERTIFICATION 50001


Grand Opening Aurea
04.11.2014

Opening_RW C.Tönnies | G. Duin | E.T. Isim




What's new...

...at Pharma Action

24.08.2016
Successful ISO 50001:2011 Audit
We are proud to announce another success: all three locations of Pharma Action have passed the audit according to ISO 50001:2011 Energy Management Systems.

We will continue our systematic focus on continuously reducing energy consumption at all our locations. This is a great team effort from both Toennies and Pharma Action to reduce our carbon footprint. Special thanks to all members of the EnMS Team. 

The ISO 50001:2011 Energy Management System defines the requirements of the implementation, maintenance and improvement of energy management systems. This structure helps organisations to consistently reduce energy consumption and thus cost and greenhouse gas emissions.

10.08.2016
Successful Re-GMP-Inspection of PHARMA ACTION's Crude Heparin Factory
We are proud to announce that our crude Heparin factory in Rheda-Wiedenbrueck was successfully audited by the competent authority in GMP compliance without any critical or major deficiencies. The relevant GMP certificate according to Art. 111 (5) of Directive 2001/83/EC was issued.

21.03.2016
Pharma Action's API factory successfully passes GMP inspection
Pharma Action is proud to announce that the competent authority of Germany has re-certified the Berlin site for compliance of GMP principles for active substances referred to in Article 47 of Directive 2001/83/EC.

21.05.2015
#1 Worldwide: Crude Heparin Factory receives pharmaceutical Production License and GMP-Certificate. The first and only GMP certified Crude Heparin factory world wide!
As of the second quarter of 2015 the new crude manufacturing site in Rheda-Wiedenbrück has officially been licensed to produce crude heparin by the German authorities. At the same time it has been certified to comply with the Good Manufacturing Practice (GMP) requirements.

04.11.2014
Grand Opening Crude Heparin Factory
Rheda-Wiedenbrueck, 4 November 2014. The opening ceremony for Pharma Action's new factory located in the Aurea industrial park took place today. The factory, which will produce the pharmaceutical intermediate crude heparin, will start production in the 4th Quarter of 2014. This will signify the possibility to process around 60% of Europe's traceable heparin raw material in Germany. Toennies, a global company with many years of experience and expertise in the meat industry, fulfills all international requirements with respect to quality and hygiene. This expertise also ensures the complete traceability of the heparin raw material (pig intestinal mucosa). The opening was attended by Garrelt Duin, Northrhine-Westphalia's Minister for Economic Affairs, as well as numerous mayors and other political and economic decision makers.

Northrhine-Westphalia's Minister for Economic Affairs Garrelt Duin praises the Collaboration between Toennies and Pharma Action: "The opening of the Pharma Action Aurea factory is a good example of how companies with different focuses can come together to exploit synergy effects to enter into new markets. The collaboration between Toennies and Pharma Action is an innovative accomplishment, which gives a boost to the economy in Ostwestfalen".

Prof. Dr. Susanne Alban explains the Meaning of Heparin
The event concluded with a keynote lecture about heparin and its medicinal applications given by Professor Dr. Susanne Alban, Professor of Pharmaceutical Biology and head of the Pharmaceutical Institute at the Christian-Albrechts-University in Kiel. Her talk summarised current ressearch on the area and gave a perspective on relevant topics for the industrial manufacture of heparin.
26.09.2014
Successful Virusinactivation Process
Pharma Action successfully completed the virus inactivation study for the new Crude Heparin factory in Rheda-Wiedenbrueck. This completes the profound safety profile of bulk hepasafe® Crude Heparin, including full traceability to the livestock breeder and ante-/ post-mortem veterinary certification.

Miscellaneous

22.02.2017
EU MAHs for Heparin Products are requested to prove full transparency of their Heparin Supply Chain
The European Medicines Agency (EMA) has requested all European marketing authorisation holders (MAH) of finished products containing Heparin to give full information on the manufacturing process of Heparin with special focus on the intermediate Heparin manufacturing sites. If this information is missing from the dossier, the MAHs are requested to present appropriate variation(s) to update this part of the dossier accordingly, as soon as possible, and anyway, but no later than 6 months from the present date (10.01.2017, EMA/INS/GMP/18696/2017, see:
PDF-file).

Exactly this information is Pharma Action's unique selling proposition and part of Pharma Actions Module 3 (ASMF/"DMF").

04.03.2016
French Authorities take action: Heparin supply chain risk
On the 25th of February 2016 the French National Agency for Medicines and Health Products Safety took following action after their audit of a Heparin API producer of two Heparin APIs:

1. Withdrawal, of current valid GMP certificate
2. Removal of the site from the marketing authorisation(s)
3. Recall of batches already released
4. Statement of non compliance: prohibition of supply
5. Suspension / voiding of CEP (action to be taken by EDQM)

For further Information view Report No : 15MPP066NCS on the EudraGMDP Website
or click here for the PDF-file

01.01.2015
New EP 8.3 supplement on Heparin
SUPPLEMENT 8.3
Definition. The scope has been restricted to heparin material of porcine origin since some of the latest requirements do not apply to materials of other origins and heparin medicinal products currently on the European market are all of porcine origin. Further to the replacement of the clotting assay by 2 chromogenic assays for anti-factor IIa activity and anti-factor Xa activity in general chapter 2.7.5. Assay of heparin, potency is now measured by the assay of anti-factor IIa activity.
Production. A statement was introduced during the last revision, which requires testing for identity of the source species and the absence of material from other likely cross-contaminant species. Further indications have been added that reflect current widely spread practices.
Identification: a requirement for the ratio of anti-factor Xa activity to anti-factor IIa activity has been introduced; a ratio of 1 is typical of unfractionated heparin.
Sodium: range modified in line with current batch data.
Implementation date: 01.01.2015

28.06.2012
European Commission updates GMP Guideline to increase regulations on APIs
The new Annex 2 (effective from 31st of January 2013) of the EU guidelines for
Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
defines the starting point for APIs from animal origin (e.g. Heparin) as the collection of the "...organ, tissue or fluid...". Therefore in order to be compliant with the GMP requirements API producers need to assure a traceable supply-chain back to the slaughterhouse. Pharma Action fully complies with the new requirements by being part of the Tönnies Group with a system of full traceability already implemented.
Click here for the document (.pdf)

16.02.2012
EMA - Reflection Paper on the use of starting materials
New EMA / US FDA requirements state that the manufacturing process starts with the source of the mucosa, e.g. the slaughterhouse.
Source:
"Module 3 of the marketing authorization dossier should cover the whole manufacturing process starting from the sourcing of the mucosa. Aspects with potential impact on product quality and safety needs to be presented in sufficient detail e.g. species and country of origin, traceability from slaughterhouses/abattoirs, confirmation that the animals used are fit for human consumption."
Click here for the document (.pdf)

14.02.2011
EDQM excludes biological active substance from CEP procedure
EDQM does not accept new CEP applications for biological active substance.
Further information (opens in new browser-window):
Position paper
Concerned substances

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