Standards and Guidelines Aligning with Our Services

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 At Probionalytix Labs, we uphold the highest international standards and regulatory guidelines to ensure precision, reliability, and compliance in our probiotic and microbiome testing services. Below is a summary of the ISO standards, pharmacopoeias, monographs, and guidelines associated with our core services 

Standards and Guidelines:

• ISO 16140: Validation of microbiological methods for strain identification and typing.
• ISO 11133: Microbiology of food, animal feed, and water — Testing of culture media.
• Monographs: Specific microbial and probiotic strain requirements in USP, Ph. Eur., and BP.

Standards and Guidelines:

• ISO 20189: Molecular microbiology — General requirements for molecular techniques.
• WHO guidelines for genomic sequencing applications in microbiome research.
• Pharmacopoeial Monographs: Standards for microbial profiling in probiotics and biological products.

Standards and Guidelines:

• ISO 20387: General requirements for biobanking.
• OECD Guidelines: Biological resource centers for strain storage and maintenance.
• Monographs: Specific probiotic strain storage protocols under USP and Ph. Eur..

Standards and Guidelines:

• ISO 16140: Validation of methods for demonstrating efficacy in probiotics and microbiome research.
• ICH Q6A/Q6B: Test procedures and acceptance criteria for new drug substances and products.

Standards and Guidelines:

• ISO 10932: Assessment of microbial antibiotic resistance (Minimum Inhibitory Concentration methods).
• WHO/FAO guidelines on probiotics in food for antibiotic susceptibility testing.
• Monographs: Resistance testing methodologies outlined in USP and Ph. Eur..

Standards and Guidelines:

• ISO 19344: Quantification of lactic acid bacteria by flow cytometry.
• USP <1111>: Microbiological examination of non-sterile products.
• Monographs: Probiotic viability specifications under USP, BP, and Ph. Eur..

Standards and Guidelines:

• ISO 14698-1/2: Biocontamination control in cleanrooms and controlled environments.
• USP <1116>: Microbiological control and monitoring in cleanroom environments.
• Ph. Eur. Chapter 5.1.4: Microbiological quality of non-sterile pharmaceutical preparations.

Standards and Guidelines:

• ISO 11930: Evaluation of antimicrobial preservation efficacy.
• USP <51>: Antimicrobial Effectiveness Testing.
• WHO guidelines for assessing the stability and safety of probiotics.

Standards and Guidelines:

• ISO 20189: Molecular techniques for studying probiotic gene expression.
• WHO/FAO guidelines on evaluating probiotics' mechanisms of action.

Standards and Guidelines:

• ICH Q8 (R2): Pharmaceutical development for new formulations.
• ISO 22000: Food safety management systems for probiotic food products.
• FAO/WHO Guidelines: Safe formulation and efficacy evaluation of probiotics.