Pharmaceutical and Analytical Services (PAS)
The PAS department is the interface for issues related to production, quality control and quality assurance at AMCAPHARM and the regulatory affairs department of the Marketing Authorization holder as well. By focusing all dossier relevant activities in one single department, workflows are optimized and provide a high process depth.
GAP analyses are performed by default to identify descrepancies between the dossier and recent European regulations as well as risk assessments. The scope of suppliable services is modular and customizable.
Quality Control (QC)
The analyses are accomplished by the QC department of AMCAPHARM. Both, common analytical techniques like HPLC/PAD, UV/Vis- or IR-spectroscopy and special procedures of the Ph. Eur. are established at the QC and are applied to suppositories and liquid dosage forms.
Analytical procedures for the determination of related substances or for assays can be updated and revised so that they comply with the latest regulations. The necessary expertise is available and statistical approaches of quality control are part of the ap-proach.
Scope of Services
PAS and QC provide the following services in close cooperation
Special analytical questions are raised, that cannot be answered by AMCAPHARM? Techniques like ICP/MS or microbiological tests are needed, but not available in-house? AMCAPHARM cooperates with qualified contract laboratories so that manifold the offered expertise that be applied to the individual products.
We can assist MAHs in the following fields