Control is one good thing. Hedinger wants to be better. For this reason we host regular external audits of our integrated Quality and Environmental Management System.
In the meantime we are certified against these standards for more than 18 years and our integrated Management System contains more than 1.200 documents.
EU-GMP Part 1 und 2
The competent GMP-Inspectorate, RP Tübingen, inspected Hedinger according EU-GMP part II (GMP for active pharmaceutical ingredients)in February 2015 and granted a GMP certificate for the site in Stuttgart. Hedinger holding a manufacturing license in accordance with Art. 40 of Directive 2001/83/EC was also inspected according to EU-GMP part I (GMP for medicinal products) and received a certificate of GMP compliance of a manufacturer.
The competent GMP-Inspectorate, LVSA Halle (Germany), inspected Hedinger according to EU-GMP Teil II (GMP for active pharmaceutical ingredients) in June 2015 and granted a GMP certificate for the site Teutschenthal. Hedinger holding a manufacturing license in accordance with Art. 40 of Directive 2001/83/EC was also inspected according to EU-GMP part I (GMP for medicinal products) and received a certificate of GMP compliance of a manufacturer.
Hedinger participated in February 2013 as the first excipient supplier in the pilot phase of the EXCiPACTTM certification scheme providing third party certification of GMP and GDP compliance. GMP and GDP certificates for Hedinger have been granted by mdc on June 25th, 2013. mdc (medical device certification GmbH, Stuttgart, Germany) is the first approved EXCiPACTTM certification body. Our EXCiPACTTM GMP and GDP certificates in conjunction with the detailed audit report of the independent auditor of mdc provide evidence of our high level of GMP and GDP compliance according to the global EXCiPACTTM standard.
EXCiPACTTM is a global third party certification system providing verification and certification of GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices) compliance of manufacturers and distributors of pharmaceutical excipients. This system contributes to excipient safety, transparency of excipient supply chain and provides independent information about GMP/GDP compliance of excipient suppliers which may be used by pharmaceutical companies to reduce their own audit burden of certified suppliers.
The EXCiPACTTM standard is aligned to the ISO 9001 quality system certification. Therefore, an EXCiPACTTM certificate is only valid in conjunction with an ISO 9001 quality system certification. EXCiPACTTM certification audits are carried out every 3 year at the supplier sites, surveillance audits in the years between ensure the maintenance of the quality system standard between the certification audits.
1. General Part (Distributor Standard Activities - Di)
2. Section S: Site inspection
3. Section Cs: Chlorinated solvents
The ESAD programme helps to successfully implement and evaluate Responsible Care Principles in a chemical distribution company.
In 1999, Hedinger was the first European chemical distribution company to undergo the ESAD assessment. In April 2008, Hedinger was audited against ESAD in Stuttgart and Teutschenthal, by a third-party auditor from Swiss TS. All parts of ESAD, except those dealing with chlorinated solvents, formed the basis of this assessment. We are proud to have achieved greater than 90% compliance with the requirements of ESAD at both locations. Further, this confirms, that Hedinger honours the principles of Responsible Care at an extremely high level. This is evidence for our high standards in safety, environmental protection and health protection, while working with chemical products throughout all areas of Hedinger.
ESAD is a standardized voluntary assessment system, which measures the HSE standards¹ of chemical distribution companies. However, ESAD should also be used by distributors, to check their compliance with the requirements of the Responsible Care programme.
ESAD has been developed by a joint group of experts (CEFIC and FECC and is used by independent auditors to inspect chemical distribution companies. It is intended that re-assessments are carried out every three years. The auditors have been trained in a joint course run by CEFIC (European Chemical Industry Council) and FECC (European Association of Chemical Distributors) and have passed a qualifying examination. ESAD is part of the SQAS-Program²: objectivity, neutrality, transparency and free access to the system, for the users in the chemical industry.
ESAD is structured as follows:
I. Assessment Guidelines
Guidelines for interpreting and evaluating the following questionnaire.
The questionnaire for assessing the relevant processes and operations in a company is divided into three parts as follows:
¹HSE: Health, Safety, Environment
²SQAS: Safety and Quality Assessment Systems