Risk Evaluation and Control Strategy

Usługi doradcze w zakresie działalności gospodarczej, w tym usługi badawcze i eksperymentalno-rozwojowe

Tryb zamówienia	Zapytanie ofertowe
Rodzaj zamówienia	Usługi
Tytuł	Risk Evaluation and Control Strategy
Zamawiający	Dostępne dla zalogowanych
Miejsce realizacji	Kraków
Data publikacji	2026-04-24
Data składania ofert	04/05/2026, Godzina 23:59
Dokumenty do pobrania	Dostępne dla zalogowanych
Kod CPV	731100006 Usługi badawcze
Numer przetargu	7121657

<div>
    <h1>Zapytanie ofertowe nr 24 04 2026 IM - Risk Evaluation and Control Strategy for Impurities in Support of IMPD Preparation</h1>

<h2>Załączniki</h2>
    <ul>
            <li><span class="was-link">Zapytanie ofertowe 24 04 2026 IM (RFQ 24 04 2026 IM)</span></li>
            <li><span class="was-link">Formularz ofertowy do zapytania 24 04 2026 IM (Offer form to RFQ 24 04 2026 IM)</span></li>
        </ul>
    
    <h2>Części zamówienia</h2>

<h3>Risk Evaluation and Control Strategy</h3>
        <strong>Przedmioty zamówienia</strong>
                    <p>Risk Evaluation and Control Strategy for Impurities in Support of IMPD Preparation<br />
Detailed impurities control evaluation services related to the proprietary clinical phase 1-suitable API manufacturing process:<br />
<br />
1.	Mutagenicity / Genotoxicity Assessment:<br />
<br />
1.1.	Conduct genotoxicity and mutagenicity assessment of all identified and potential organic impurities using Lhasa DEREK Nexus and Lhasa SARAH Nexus or equivalent (QSAR) expert rule – based and statistical prediction systems recognized by global regulatory agencies under ICH M7(R2).<br />
1.2.	Assess potential structural alerts, supporting conclusions with scientifically justified expert review following ICH M7 guidelines (including classification into Classes 1–5).<br />
1.3.	Utilize Lhasa’s Mirabilis or equivalent risk-based modeling tools for purge and likelihood analysis, consistent with ICH M7 recommendations on applying process knowledge and fate/purge principles (optional).<br />
<br />
2.	Impurity Identification and Process-Based Risk Analysis:<br />
<br />
2.1.	Propose a comprehensive list of process - and degradation-related organic impurities based on received structures and process understanding.<br />
2.2.	Evaluate each impurity for mutagenic potential and relevance, consistent with ICH Q3A/B impurity frameworks and ICH M7 requirements.<br />
<br />
3.	Carryover / Purge Assessment (optional):<br />
Perform data-supported assessment of impurity carryover risk across the API manufacturing process using Lhasa Mirabilis software or other equivalent, regulator-accepted purge modeling tools. Apply ICH M7(R2) and ICH Q9 quality risk management principles demonstrating adequate control strategies, purge justification (e.g., Option 4), and risk-ranking of impurities. <br />
<br />
4.	Nitrosamine Risk Assessment:<br />
<br />
4.1.	Conduct a step-by-step nitrosamine formation risk assessment in alignment with the EMA’s &quot;Guideline on the Limits of Genotoxic Impurities&quot;, EMA/FDA Nitrosamine Guidelines, ICH M7(R2), and supporting Q&amp;A documents. <br />
4.2.	Evaluate potential nitrosamine precursors, nitrosating conditions, reagent/solvent compatibility, and formation pathways throughout the full synthetic route.<br />
4.3.	Provide risk classification and recommendations for mitigation and control strategies consistent with global regulatory expectations.<br />
<br />
All evaluations must be conducted following the principles outlined in ICH M7(R2) for mutagenic impurities, ICH Q3A(R2), ICH Q3B(R2), ICH Q7, and ICH S9 (where applicable to oncology products), as well as relevant EMA/FDA nitrosamine guidance, including the FDA&#039;s &quot;Risk Assessment of Nitrosamine Impurities in Human Drugs&quot; and associated Q&amp;A documents.<br />
Selected bidder must provide the deliverables as results of the service. The cost of the deliverables given below must be included in the offer or calculated into the price of the services:<br />
•	Mutagenicity assessment report based on DEREK/SARAH or equivalent (ICH M7-compliant QSAR evaluation).<br />
•	Impurity list with carryover/purge justification, supported by Mirabilis or equivalent simulations and ICH M7 fate/purge principles (Optional).<br />
•	Nitrosamine risk assessment report aligned with EMA/FDA guidance and ICH M7.<br />
</p>

<h2>Kryteria oceny</h2>
                <p>Criterion 1: Total Price – 90,00 points<br />
Kryterium 1: Cena całkowita - 90,00 punktów</p>
                <p>Criterion 2: Ecological Aspect – 10,00 points<br />
Kryterium 2: Aspekt proekologiczny - 10,00 punktów</p>
            
        <h2>Warunki zmiany umowy</h2>

<p>Warunki zmiany umowy zostały zamieszone w załączonym zapytaniu ofertowym w wersji PDF.<br />
The terms and conditions of the contract amendment are set out in the attached PDF version of the RFQ.</p>
    </div>