Dietary supplements

LEGAL REQUIREMENTS

According to Directive of 25 September, 2006 on food safety, dietary supplements are foodstuff which supplement regular diet and which are concentrated sources of nutrients and vitamins. Dosage form of supplements is similar to oral medicinal products. This products are also very often produced by pharmaceutical producers.

Why the microbial quality of dietary supplements should be controlled?

Reduced effect and potential adverse drug reaction can be caused by presence of microorganisms in product. Producer of supplements should provide customer safety as much as possible. It is absolutely crucial to eliminate the risk of microbiological infection.

Our certificates and Authorizations

MIKROLAB is authorized by Main Pharmaceutical Inspectorate to 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 remains microbiologically stable while warehousing
  3. Microbiological tests at research and development stage

Microbiological analyzes are performed in the area of ​​determinations

  • 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


Testing methods and criteria of assessment:
MIKROLAB offers dietary suplements tests in accordance with customer specifications based on regulations for food and for medicinal products:

We perform tests according to:

  1. Ph. Eur.
  2. ISO Standards:
  • PN-EN ISO 4833-1:2013-12
  • PN-ISO 21527-1:2009
  • PN- ISO 16649-2:2004
  • PN- ISO 21528-2:2005
  • PN-EN ISO 6888-2:2001+A1:2004
  • PN-EN ISO 6579-1:2017-04
  • PN-EN ISO 7932:2005