WE GUARANTEE THE MOST RELIABLE QUALITY BECAUSE WE COMPLY WITH THE STRICTEST STANDARDS.
Seratec has invested and will invest more in the quality business, a tool of excellence in certification, and guarantee of the mastery of good pharmaceutical practice.
Seratec is certified as a company performing research and development (R & D) on behalf of ordering parties from the pharmaceutical industry, in the form of a CIR certification awarded by the French Ministry of Higher Education and Research.
Since the 1990s, Seratec has organized its R & D activities for active pharmaceutical ingredients, managed as projects, by specifying the requirements for its quality management system in order to demonstrate its ability to consistently provide a product that complies with the demands of customers and applicable statutory and regulatory requirements. As part of our business of developing and manufacturing active pharmaceutical ingredients, our quality management system operates in a process of continuous evaluation to ensure it continues to comply with requirements and to continuously improve it.
Surprisingly enough, although regulatory requirements related to these activities have long been established and verified in the USA (Code of Federal Regulations - Title 21, 1977), it is only recently that these obligations have appeared in Europe.
In the 1990s, the FDA and the PIC / S and other stakeholders were interested in developing recommendations specific to good manufacturing practice (GMP) of active pharmaceutical ingredients. This was followed in September 1996 by a draft guide at the initiative of the PIC / S. Meanwhile the International Conference on Harmonisation (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use was created, bringing together experts from the three main regions of the global pharmaceutical industry - USA, Japan, Europe - which has developed to date fifty harmonized guidelines. In February 1998, the ICH adopted the topic of GMP requirements for active pharmaceutical ingredients (ICH Q7), which were formalized in July 2000 and adopted consecutively by the regulatory authorities. To date these ICH Q7 good manufacturing practices for active pharmaceutical ingredients are recognized by major global health authorities.
In the absence of an implementing decree on the need for inspection, although established in 1998 for French manufacturers of APIs (and required at the EU level in 2004), our approach in 2001 was oriented towards having our business evaluated by the only health authority who mastered it: the US FDA. This was achieved with the first acceptance on this market in 2003. It was only in 2007 that we were able to benefit from an inspection of our activities by the French drug agency. We have subsequently passed various inspections in 2010 and 2014 for Europe and again in 2009 and 2013 for the USA, now the permanence of the high-level qualification of our business and of our facilities with these Authorities.
It is only since 2004 that pharmaceutical companies have been required to use only active substances which have been manufactured in accordance with these Good Manufacturing Practices (GMP) for active substances, like at Seratec, by amendment to the European guidelines 2001/83 / EC (instituting an EC code on medicinal products for human use). Finally the amendment of May 2011 of this same directive intended to fight against falsified medicines (2011/62 / EU) requires the protection of the European market for active substances (especially) showing a false identity or falsified traceability.
In this directive, a falsified medicine is a medicine that contains a false presentation:
- of its identity, its name, its composition and its dosage. This applies to any of its components, the active ingredient in particular.
- of its source (manufacturer, country of manufacture, country of origin and the marketing authorization holder)
- of its history including distribution channels used.
It excludes from this definition unintentional quality defects.
For the drug manufacturer this implies new requirements:
- reporting relating to active substances and their manufacturers (written confirmation in the marketing authorization application that the API manufacturer is GMP - the “QP declaration”) as well as excipients (risk analysis);
- To report to the authorities any falsified medication or suspected of being so, through European drug recall systems;
- To perform audits - or through an entity acting on its behalf – of the manufacture and distribution of active substances in order to provide evidence of its obligation to source only API manufactured under GMP.
For the manufacturer of active ingredients this implies new requirements:
- The business reporting obligation for manufacturers, importers, or distributors of active substances; An inventory of the changes affecting general information is to be done annually but immediate reporting is required if the safety or quality of the API is concerned;
- The obligation of inspections by Member States (triggered upon non-compliance or after risk analysis);
- The obligation to manufacture active substances under GMP, whether these substances are manufactured in the EU or are imported (requirements therefore also apply to products manufactured outside the EU).
- The establishment of appropriate and effective sanctions for any activity related to falsified medicines;
- The need for an exchange of information between Authorities on the measures adopted;
These new supply chain assessment requirements are to fight unfair competition from countries outside the EU, suppliers of more than 80% of the APIs in Europe, and restore opportunity for European manufacturers to exercise their pharmaceutical expertise. The objective of the new amendment to Directive 2011/83 / EC is indeed to protect the functioning of the domestic market for medicinal products while ensuring a high level of protection of public health against falsified medicines. It therefore incorporates the supply chain assessment requirements and its logistics, detailed in an update of Chapter 5 (Production) of the European GMP.
This directive, by setting the requirements for non-European countries, could be accused of protectionism. However, it applies to all suppliers of APIs (among others), and requires from all that non-falsified products be manufactured, meaning those whose quality, source identification and traceability can be guaranteed. In other words, regardless of the API manufacturer, GMPs apply to all.
European pharmaceutical expertise was first exhausted by the game of concentration of the pharmaceutical industry in the deteriorating context of globalization, alongside the disappearance of family laboratories from the French territory. Proof that the authorities are not solely responsible.
Therefore it seems obvious to us that the expertise of Seratec must not follow the de-industrialization of our country, but can represent the added value sometimes missing in a strong and justified representation of French pharmaceutical expertise.
This is the driving force of our inspections, approvals and certifications.