SIST EN 12689:1999

Biotechnology - Guidance on assessment of the purity, biological activity and stability of microorganism based products

This European Standard gives guidance on assessment of technical specifications of microorganism based products (MBPs) for product quality evaluation. It is also applicable for purposes of product registration. NOTE 1: In this European Standard, the technical specifications are considered to be purity, biological activity and stability of microorganism based product. This European Standard describes criteria and factors considered for the validity of the assessment of the technical specifications.

Biotechnik - Leitfaden zur Bewertung der Reinheit, biologischen Aktivität und Stabilität von Produkten, die auf Mikroorganismen basieren

Diese Europäische Norm gibt im Hinblick auf die Beurteilung der Produktqualität eine Anleitung zur Bewertung technischer Spezifikationen von Produkten, die auf Mikroorganismen basieren (MBPs). Sie ist auch für Zwecke der Registrierung von Produkten anwendbar. ANMERKUNG 1: In dieser Europäischen Norm werden die Reinheit, biologische Aktivität und Stabilität von Produkten, die auf Mikroorganismen basieren, als technische Spezifikationen betrachtet.

Biotechnologie - Guide pour l'évaluation de la pureté, l'activité biologique et la stabilité des produits a base de microorganismes

La présente norme européenne donne des indications relatives à l'évaluation des spécifications techniques des produits à base de microorganismes pour l'évaluation de la qualité des produits. Elle s'applique également à l'enregistrement des produits. NOTE 1: Dnas la présente norme, la pureté, l'activité biologique et la stabilité sont considérées comme les spécifications techniques d'un produit à base de microorganismes. La présente norme européenne décrit les critères et les facteurs qui sont pris en considération pour la validité de l'évaluation des spécifications techniques.

Biotehnologija - Navodilo za ocenjevanje čistosti, biološke aktivnosti in obstojnosti mikrobioloških proizvodov

General Information

• Status: Published
• Publication Date: 30-Nov-1999
• ICS: 07.080 - Biology. Botany. Zoology
• ICS: 07.100.01 - Microbiology in general
• Technical Committee: BTH - Biotechnology
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Dec-1999
• Due Date: 01-Dec-1999
• Completion Date: 01-Dec-1999
• Directive: 90/219/EEC - Contained use of genetically modified micro-organisms
• Directive: 90/220/EEC - Deliberate release into the environment of genetically modified organisms
• Directive: 90/679/EEC - Protection of workers from risks related to exposure to biological agents at work
• Mandate: M/BC/CEN/91/19 - Mandate for CEN on biotechnology
• Ref Project: EN 12689:1998 - Biotechnology - Guidance on assessment of the purity, biological activity and stability of microorganism based products

Overview

EN 12689:1998 (CEN) provides guidance for the assessment of technical specifications of microorganism based products (MBPs). The standard focuses on three core attributes used for product quality evaluation and, where relevant, regulatory registration: purity, biological activity, and stability. It outlines the criteria and factors to consider to ensure that assessments of these attributes are valid, consistent and defensible.

This guidance applies to MBPs across research, industrial and regulatory contexts where a documented evaluation of product quality is required. EN 12689:1998 helps manufacturers, quality managers and regulatory specialists frame assessment strategies and document outcomes for product dossiers.

Key Topics

• Scope and definitions: Clarifies that the technical specifications addressed are purity, biological activity and stability of MBPs and that these form the basis for product quality evaluation.
• Assessment criteria: Describes the factors to consider when judging the validity of tests and measurements used to evaluate MBP technical specifications (for example, suitability of methods, reproducibility, and appropriate controls) without prescribing specific numeric thresholds.
• Documentation and reporting: Highlights the importance of clear documentation to support product quality claims and for use in registration submissions.
• Reliability and validity considerations: Emphasises factors such as method selection, sample handling, and evidence of consistent performance over time.

Applications

EN 12689:1998 is practical for organizations involved in the development, manufacture, quality control and registration of MBPs. Typical applications include:

• Preparing quality evaluation reports for internal release or external review.
• Compiling technical dossiers for product registration with regulatory authorities.
• Designing and justifying test strategies for purity, potency and shelf-life monitoring.
• Establishing acceptance criteria and stability monitoring programs that are robust and auditable.

Benefits of following this guidance:

• Improved consistency and defensibility of product quality assessments.
• Clearer documentation paths for regulatory submissions.
• Better alignment between laboratory methods and product specification requirements.

Related Standards

Relevant complementary standards and guidelines may include general microbiology, quality management and stability testing standards (national and international), as well as regulatory guidance addressing product registration and safety assessment. Users should consult applicable CEN/ISO standards and national regulations when applying EN 12689:1998 to specific MBP types.

For implementation, combine the conceptual guidance of EN 12689:1998 with validated laboratory methods and regulatory-specific requirements to produce a comprehensive, auditable quality assessment program for microorganism based products.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotechnik - Leitfaden zur Bewertung der Reinheit, biologischen Aktivität und Stabilität von Produkten, die auf Mikroorganismen basierenBiotechnologie - Guide pour l'évaluation de la pureté, l'activité biologique et la stabilité des produits a base de microorganismesBiotechnology - Guidance on assessment of the purity, biological activity and stability of microorganism based products07.100.01Mikrobio
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