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Regulatory authorities across Europe are increasingly and consistently requesting that each radiopharmaceutical producer should assess and document the qualification of all suppliers of starting materials, such as active pharmaceutical ingredients and precursors as well as excipients and raw materials on a regular basis. It is expected by the regulatory bodies that the manufacturer of radiopharmaceuticals should perform regular audits at least for the suppliers of critical starting materials.
Therefore, multiple institutions across Europe are being requested to perform audits on the same suppliers, usually independently and in a non-coordinated manner. In addition, radiopharmaceuticals are often manufactured by small institutions or universities that in most cases do not have the staff resources and financial means to perform these audits regularly if at all.
We conduct SASAI audit reports per EU Regulation No. 1252/2014 and EU Commission Directive (EU) 2017/1572 in regards to the principles and guidelines of Good Manufacturing Practice (GMP) for medicinal products for human use, as per The European Medicines Agency (EMA) with the aim to harmonise GMP activities within the EU. SASAI audit reports comply with GMP standards meeting the requirements of marketing authorisation or clinical trial authorisation, as well as consistent high quality and being appropriate for their intended use.
The EU has signed mutual recognition agreements (MRAs) with third-country authorities for the conformity assessment of regulated products. To find the list of those countries, please visit the EMA web site.