Pharmaceutical and Analytical Services (PAS)
& Quality Control (QC)

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

  • Analytical method validation
  • Validation of test procedures acc. to ICH Q2
  • Stability programs / Finished Dosage Forms
    • OGS, climatic zone II as well
    • ICH at 25/60, 30/65 und 40/75
    • Filing of Stability reports
  • Process validation incl. Holding Time Tests
  • Management of product- and analytical method transfers
  • Product specific risk assessments
  • Review of 3rd party audit reports / Q7 Declarations
  • API manufacturer and supply chain qualification in tight collaboration with the Quality Assurance department
  • Accomplishment of release analyses

Range of Services

External Services

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.

Pharmaceutical Development

We can assist MAHs in the following fields

  • Galenic development of suppositories and liquida
  • Optimization of master batch formulas and products
  • Analytical method development and validation
  • Scaling-up to commercial batch sizes
  • Process validation
  • Assistance during product transfer
  • Running stability programs (ICH / OGS)