Medicinal products and investigational products

LEGAL REQUIREMENTS

Reduced therapeutic effect and potential adverse drug reaction can be caused by presence of microorganisms in product. Each launched batches of medicinal products and investigational products must meet principal requirements, and have confirmed microbiological purity according to product categories described in Pharmacopoeia.

OUR CERTIFICATES AND AUTHORIZATIONS

MIKROLAB is authorized by Main Pharmaceutical Inspectorate in quality control testing of medicinal products and investigational medicinal products (products in clinical trials). MIKROLAB is GMP certificate holder.

What do we offer?

  1. Microbiological tests needed to batch release
  2. Test to prove that product remain microbiologically stable while warehousing
  3. Raw materials/components tests
  4. Validation of tests methods and cleaning processes
  5. Packaging microbiological tests
  6. Industrial water tests / Tests for water used during the production process
  7. Challenge tests – assessment of preservatives effect
  8. Monitoring of manufacturing environment
  9. Microbiological expertises/opinions, to reduce a risk of microbial infections
  10. Solving existing microbiological problems in production line

Microbiological tests at research and development stage

  • Total aerobic microbial count
  • Total moulds count
  • Presence of Escherichia coli
  • Presence of Staphylococcus aureus
  • Presence of Pseudomonas aeruginosa
  • Presence of Salmonella
  • Presence of Clostridium
  • Presence of Candida albicans
  • Presence of Bile-tolerant gram-negative bacteria

Test methods and criteria of assessment:

MIKROLAB offers tests in accordance with:

  • European Pharmacopoeia
  • Polish Pharmacopoeia
  • Customer specification