In 1997 heeft het VHCP het initiatief genomen tot het opstellen van een internationale gedragscode, de zogeheten Guiding Principles, voor de export van grondstoffen voor zowel gevoelige producten als humane geneesmiddelen. Inmiddels is het VHCP niet langer de enige die een dergelijk initiatief heeft genomen. Ook de World Health Organisation (WHO) deed op dit terrein een aantal aanbevelingen. De Guiding Principles van het VHCP zijn zoveel mogelijk afgestemd op de aanbevelingen van de WHO en luiden als volgt:
Guiding Principles for export of chemical/raw materials that are intended as an ingredient of a medicinal products for human use:
Whereas medicinal products for human use are indispensable to achieve a high degree of health protection;
whereas the quality and the safety of these products should be beyond dispute;
whereas under GMP-rules it is common practice for the manufacturer to ascertain that chemicals/raw materials, before being incorporated into medicinal products, are of good quality and meet the agreed specifications;
whereas under the present circumstances this common practice has no legal basis in all countries where medicinal products are being manufactured;
whereas chemical trade and distribution is committed tot Responsible Care and to continuous progress in the areas of health, safety and environment.
Chemical trade and distribution have adopted the following Guiding Principles:
1. Each supplier of chemicals/raw materials, intended, as an ingredient of a medicinal product for human use, must – before shipment – have available in respect of those chemicals/raw materials a Certificate of Analysis issued by the producer (working under GMP or another suitable quality management system, such as the ISO 9000 series)* or by a certified laboratory (working under GLP or comparable conditions) and
a. Material Safety Data Sheet. From these documents it should be possible to obtain the following data: a. the physical and chemical properties
b. the effects thereof on human health and the environment
c. the instructions for handling and storage and preferably also
d. the purpose(s) for which it is intended to be used. At all times such documents will be made availble to the customer
2. Any chemical/raw material that, due to its nature or its purity, is intended for use in a medicinal product for human use, should be labelled as such (e.g. USP, BP, EP, DAB).
3. Quality records and, if required, samples taken from the same batch as the chemical/raw material supplied, should be kept at the disposal of the supplier for a reasonable period of time, which enables the supplier to provide evidence of the quality of the chemicals/raw materials supplied, if need be.
Chemical trade and distribution call upon producers to make these documents available in time