laboratorium Services

Interdos Pharma offers batch testing and batch release services for human pharmaceutical products and medical devices. We are well equipped to execute method transfers and routine batch-release testing for pharmaceutical companies in accordance with GMP.

Interdos Pharma works for global pharmaceutical manufacturers from countries without a Mutual Recognition Agreement (MRA) who wish to import their products within the European Economic Area (EEA) where batch testing is mandatory prior to release.

In close collaboration with Basic Pharma Manufacturing we provide a service package including import, customs clearance, storage and batch release/certification. QP services of the products is also included into our portfolio.

Our customer focused, integrated Interdos Pharma/Basic Pharma Manufacturing solution includes:

• Analytical method transfer (AMT)
• Batch testing of commercial batches according to approved analytical methods and specifications
• Full analysis of all parameters to issue a batch Certificate Of Analysis
• APIs and excipient testing according to approved specifications and/or pharmacopeial methods
• Importation into the EU of human pharmaceutical products
• Warehousing, sampling and shipment of imported products
• Issuing a Qualified Person for batch release/batch certification in the EU in accordance with the Marketing Authorization
• Final product Stability Testing
• Managing the GMP Quality technical Agreement (QTA)
• Managing out-of-specifications
• Review of batch manufacturing/packaging records including deviation reports

Range of analytical test methods include:

• HPLC (UV, DAD, IR & fluorescent detection)
• DSD (Droplet Size Distribution)
• UV and IR Spectroscopy
• Identification testing and limit tests
• Tablet testing (dissolution, friability, hardness, disintegration)
• Karl Fisher
• Pharmacopeial wet chemical and physical techniques