Audits and inspections by authorities
The Bionorica production facility in Neumarkt is regularly inspected by national and international monitoring authorities. Between 2019 and 2021, due to the coronavirus pandemic, there were only two official inspections conducted in Neumarkt, both with positive outcomes:
In February 2021, the local monitoring authority, the Regierungspräsidium Oberfranken (Regional Council of Upper Franconia), carried out an inspection that resulted in new GMP certificates and a new manufacturing authorisation.
The EAEU inspection at the main business location in Neumarkt conducted by the monitoring authority in November 2021 was also successful; the corresponding EAEU GMP certificate, which will subsequently be valid for all countries of the Eurasian Economic Union, was still being prepared at the time of reporting.
In addition, the Bionorica production facility in Neumarkt is regularly audited by Bionorica sales partners and by the customers of Bionorica subsidiary Phytoneering Extract Solutions GmbH (PES); the extracts of PES are used, for example, in pharmaceutical, cosmetic and veterinary products.
In the period 2019 to 2021, a total of 15 such audits took place, each with positive results.
Bionorica reviews and audits suppliers
Not only Bionorica is subject to regular scrutiny in audits; for its part, it audits suppliers, for example with regard to compliance with the GACP, GMP and GDP guidelines. Suppliers relevant to manufacturing (including packaging materials and herbal starting materials) were classified into various classes in the 2019 to 2021 reporting period in accordance with Bionorica SE specifications and reviewed and audited accordingly. In the event of non-compliance or violations, Bionorica would seek a new supplier as a last resort. However, Bionorica focuses on long-term, sustainable cooperation and therefore on supplier development. This means that Bionorica, as a customer, helps the supplier in a spirit of partnership to improve its performance.
Extensively tested Bionorica pharmaceuticals
Bionorica’s quality control department analyses each batch of raw materials that arrives at Bionorica with regard to defined parameters and verifies compliance with GMP guidelines. In addition, the plant-based raw materials are only sourced from qualified suppliers and growers. This means that they have been tested, audited and approved by Bionorica’s Quality Management department. Just like the herbal raw materials, the “end product” is also subject to strict controls. All Bionorica pharmaceuticals are extensively tested upon leaving the Bionorica premises in Neumarkt for the pharmacies.
Drug safety: Reports on Bionorica preparations
For Bionorica, patient safety is a top priority. We therefore continuously monitor the safety profile of our medicinal products. The aim is to evaluate all data and information that become known about the safety of one of our pharmaceuticals. In addition to scientific literature and study reports, the collection and evaluation of spontaneous reports is also an essential part of this process.
Spontaneous reports refer to reports of adverse drug reactions that are “spontaneously” reported outside of systematic investigations (e.g. clinical trials, standardised data collection, etc.).
As part of our spontaneous reporting system, cases are reported to Bionorica by pharmacies, doctors, but also by affected patients themselves whenever they suspect a connection between an adverse reaction and the administration of a Bionorica medicinal product.
The most frequent recipients of such reports are Bionorica sales representatives or office staff with direct contact with customers. However, any other Bionorica employee can also learn of an adverse drug reaction to our products at work or in private.
For this reason, each Bionorica employee receives training on how to deal with reports of adverse drug reactions and how to forward them immediately to the Drug Safety team.
The Drug Safety team takes charge of the collection and further processing of the reports. For a comprehensive medical-scientific evaluation, it is often necessary to contact the person reporting the adverse drug reaction again and, if necessary, his or her treating physician.
The Drug Safety department also coordinates compliance with legal reporting deadlines to health authorities in Germany or abroad. In addition, all documented data is continuously monitored to identify possible indications of rare, previously unknown adverse reactions or a change in the frequency, type or severity of already known reactions.
Moreover, all processes in the Drug Safety department are continuously monitored for their impact on the safety of Bionorica medicinal products and on patient health. These processes are continuously reviewed for potential improvements in the scope of Bionorica’s quality management system.
No violations related to the impact of products and services on health and safety
Bionorica SE did not identify any violations of regulations and/or voluntary rules of conduct related to the impacts of products and services on health and safety during the 2021 reporting period.