" NATIONALLY AND INTERNATIONALLY AT THE HIGHEST LEVEL." Audit

Transcription

1 " NATIONALLY AND INTERNATIONALLY AT THE HIGHEST LEVEL." Audit

2 " NATIONALLY AND INTERNATIONALLY AT THE HIGHEST LEVEL." pharmaplace AG EXPLOITING POTENTIALS TOGETHER " Since 2009, we have had GMP audits on active substances conducted via pharmaplace in Asia. The content of audit reports and checklists complies with our stipulated standard. Thanks to attractive prices, the costs of an audit are repeatedly of interest to us." Dr. Helmut Gaden / Head of Quality Compliance / Haupt Pharma AG " For years now, Riemser Arzneimittel AG has been collaborating with pharmaplace AG in diverse lines of business, including auditing of active substance manufacturers. As a specialty pharmaceuticals vendor, according to our portfolio we have dealings with a large number of manufacturers. By placing orders with a third party, we have been able to pool our resources and optimise our workflows. Our company makes use of the know-how of pharmaplace s declared experts for qualification in compliance with the ICH Q7A regulations, thus ensuring compliance with legal requirements in the future as well." Silke Buß / Quality Assurance / Riemser Arzneimittel AG " For years now, pharmaplace AG has been one of our service providers for third-party audits. The audit reports issued are highly detailed and extensive. As a result, we are in a position to conduct our internal evaluation to a high standard. Moreover, the advantage of this collaboration is that, thanks to the flexibility of pharmaplace AG, audits can be carried out at short notice and necessary changes can be considered as early as during the planning phase." Dr. Daniel Bracher / Leiter Qualitätssicherung, QP / Hermes Arzneimittel GmbH "Exploiting potentials together" it was under this concept that pharmaplace AG came into being in the year 2000 thanks to the initiative of several pharmaceutical companies. In the beginning, the concept was implemented as a purchasing cooperation. Until today, pharmaplace pools its members purchasing volumes and places the negotiated large-purchaser agreements at the individual pharmaceutical companies disposal. Thus, these companies achieve terms and conditions that they could not attain on their own. With over 60 negotiated product groups and more than 130 cooperation partners, pharmaplace offers the largest active cooperation in the pharmaceuticals industry. Over the years, the concept has been continually developed further to remain consistent with the customers needs. Today, the service spectrum encompasses the following business areas: Purchasing cooperation Benchmarking Auditing Consulting The largest purchasing cooperation in the pharmaceuticals trade Over 60 negotiated product groups Over 130 cooperation partners Over 100 m volume Thanks to cost reductions, cost optimisations and increases in efficiency, pharmaplace achieves significant competitive advantages for its customers and strengthens them on a lasting basis in the market. pharmaplace s members include the top 10 pharmaceutical companies as well as small and medium pharmaceutical businesses. 1

3 Your specialist for third-party audits Your specialist for third-party audits LAWS PAVE THE WAY INTERNATIONALLY AT THE HIGHEST LEVEL In the pharmaceuticals industry, there are only limited means of changing suppliers, and this also holds true for market implementation. This in particular results from the Good Manufacturing Practice (GMP) for active substances. The pharmaceuticals industry must provide this proof through an on-site audit on the premises of the active substance manufacturer. pharmaplace aims at keeping the personnel and financial burden of an audit cost-effective for pharmaceutical companies. Consequently, pharmaplace has been successfully conducting third-party audits for several years. It assists and relieves the participating companies in preparing and conducting this important process. pharmaplace cost-effectively ensures the qualification of raw material and active substance suppliers, as well as monitoring compliance with Good Manufacturing Practice. pharmaplace supports its members depending on their individual needs and does so on a global scale. This service spectrum encompasses: independent, qualified auditors through an external neutral body (APM board) preparation of an extensive audit report in compliance with ICH Q7 valid auditing processes monitoring of active substance production at the highest level management of non-conformities (CAPA evaluation and response) mediation of audits already carried out 2 3

4 Your specialist for third-party audits Quality through experience good to know LOCALLY IN ASIA SUCCESS SPEAKS FOR ITSELF Nowadays, around 60 % of the active substances processed to pharmaceuticals in the EU originate from Asian countries such as China and India. pharmaplace has taken this into account, establishing an audit team in Asia in This team, which resides in Shanghai, is under German management and has language competencies in German, Chinese and English. It possesses a high level of technical and intercultural competence and has a good network at its disposal in the region. Travel distances are short and cost-efficiency is warranted thanks to a well thought-through planning system. Until now, pharmaplace has been able to fall back on the experience of having conducted over 200 audits. The total number of over 70 customers consist of German and international pharmaceutical companies from corporations to the Experience in figures Since 2006 Over 200 audits Over 70 customers small or medium businesses. The quality of the audits and the success speak for themselves. Your advantages: many years of experience from over 180 audits in Asia assuring cultural acceptance and high quality cost of auditing cut by up to 60 % no resources tied up in your enterprise additional auditing capacity without your own personnel resources cooperation effects thanks to the use of pooling opportunities and mediation (if requested) of audits already undertaken reimbursement if forwarding of audits to third parties is approved It goes without saying, but it s good to know information transparency, e.g. auditors CVs are made available before an order is placed confidentiality of documents and data is guaranteed If you are interested in working with us or for further information, please don t hesitate to contact us. We look forward to hearing from you. 4 5

5 pharmaplace AG Inselwiesenstraße Heilbronn Deutschland Tel.: Fax: info@pharmaplace.de Internet: