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Eurofins Biopharma Product Testing Finland >> Our Services >> Quality control & batch release testing

Quality Control

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Our analytical service portfolio covers a wide range of chemical and microbiological services. We are continuously developing our laboratory environment towards fully electronic data management, which continues to secure the integrity of analytical raw data, in compliance with the latest regulatory requirements. This, together with constant investments in our laboratory techniques and facilities, ensures that we can keep up with the needs of our clients and the continuous industry development.

By selecting Eurofins BPT Finland as your partner, you can be sure that your medicinal product meets the requirements set for its manufacture and quality control.

Our Team has more than 30 years of analytics experience in accordance with the Japanese, European and US pharmacopoeias as well as in the quality control analysis of drug products. Our service portfolio covers:

  • UHPLCs with UV and PDA/DAD detectors
  • HPLCs with UV, PDA/DAD and RI detectors
  • GC with head space, FID detector
  • FTIR (FT infrared spectrometer)
  • Spectrophotometer
  • Polarimeter
  • Titrators
  • In vitro dissolution
  • Disintegration tester
  • Friability tester

Eurofins BPT Finland offers batch release testing services for global manufacturers from countries without Mutual Recognition Agreements (MRAs). Under EU regulations, human and veterinary medicinal products imported into the European Economic Area (EEA) from third countries must be re-tested for compliance with the EU marketing authorisation (MA) and certified by a Qualified Person (QP) in order to be released onto the EU market.

Batch testing requirements for global pharmaceutical manufacturers vary significantly depending on whether or not their country has a Mutual Recognition Agreement (MRA) with the European Union

  • Countries that have MRAs with the EU include Australia, Canada, Israel, Japan, New Zealand, Switzerland and the United States. These agreements include a sectoral annex on the mutual recognition of Good Manufacturing Practice (GMP) inspections and batch certification for human and veterinary medicines.
  • In general, an MRA provides standardised, recognised procedures for the manufacture, shipment, storage and quality control of medicines. Manufacturers from these countries can bypass batch retesting for certification in the EU. This is a significant advantage as it streamlines the certification process, reduces the costs associated with retesting and mitigates delays in market entry.
  • Countries outside the EU/EEA that do not have an MRA are classified as “third countries”. Manufacturers from these countries wishing to enter EU markets must undergo batch retesting. This means that each batch imported into the EU must be retested to ensure compliance with EU standards.
  • This requirement for retesting implies additional costs for the manufacturer, including the direct costs of retesting and the indirect costs due to potential delays in market access.
  • Even for countries with MRAs, manufacturers must provide evidence that each part of a batch has been manufactured, shipped and stored consistently and safely.
  • QP certification

The legislation does not specify the exact tests required for batch release, but these tests should demonstrate that the product is fully compliant with its marketing authorisation.

The specific tests, including their specifications and laboratory methods, are agreed between the pharmaceutical manufacturer and the regulators during the marketing authorisation application process. This is an iterative dialogue involving a wide range of experts, including regulatory advisory boards, research scientists and manufacturing personnel.

Specific tests vary significantly depending on product type, mechanism of action and manufacturing process. A typical laboratory analysis for batch samples might include:

  • Physical characteristics (e.g. colour, shape, solubility for tablets)
  • Tests on active ingredients to ensure that their concentrations and any degradation products are within the regulatory and manufacturer’s tolerance ranges (usually 2-5%)
  • Microbiological and chemical scrutiny to verify the absence of hazardous materials, such as remnants of the manufacturing process

Laboratories conducting batch release testing must demonstrate the ability to perform these tests in a reproducible manner and adhere strictly and without deviation to the methodologies and procedures outlined in the marketing authorisation.

Eurofins BPT Finland laboratories are GMP certified and have been operating under a GMP licence (MIA) since 2005. We have the capability to perform GMP batch testing and batch release for non-sterile human and veterinary medicinal products; tablets, capsules, liquids, creams and powders. We also have extensive experience in batch release testing of inhalation products; dry powder inhalers (DPIs), metered dose inhalers (MDIs) and nebulisers. Choosing a batch release testing partner that not only meets regulatory requirements but also provides additional support and services can significantly enhance your quality control process and product safety.

Our integrated solution for GMP batch testing and batch release includes:

  • Analytical method transfer (AMT)
  • Batch testing and batch release of clinical and marketing batches according to the approved specifications
  • Testing of APIs according to relevant pharmacopoeias
  • Requesting import authorisation from the Medicines Agency
  • Importing Investigational Medicinal Products (IMPs) into the EU 
  • Issuing Qualified Person Declaration for IMPs and marketed products (annex 5.22)
  • Compilation of quality agreement
  • Reviewing shipping documents and transport conditions
  • Managing out-of-specification, change control, deviations and CAPAs
  • Review of batch manufacturing and packaging records
  • Batch release in accordance with Marketing Authorisation or Clinical Trial Regulation (EU) Nº536/2014.
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