La qualità del farmaco sperimentale come partner indispensabile per la ricerca clinica

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Antonella Lombardo
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52 SIMPOSIO AFI 30-31 MAGGIO 1GIUGNO 2012 - RIMINI La qualità del farmaco

1 52 SIMPOSIO AFI MAGGIO 1GIUGNO RIMINI La qualità del farmaco sperimentale come partner indispensabile per la ricerca clinica Luciano Gambini 1

2 L obiettivo di qualità del farmaco sperimentale è definito dall Annex 13: obiettivo etico, principale to ensure that trial subjects are not placed at risk, obiettivo scientifico the results of clinical trials are unaffected by inadequate safety, quality or efficacy arising from unsatisfactory manufacture

3 L obiettivo di qualità del farmaco sperimentale è definito dall Annex 13: Caratteristiche riproducibili Equally, it is intended to ensure that there is consistency between batches of the same investigational medicinal product used in the same or different clinical trials Miglioramenti qualitativi durante lo sviluppo and that changes during the development of an investigational medicinal product are adequately documented and justified

4 Attuale ed obbligatorio L applicazione delle Good Manufacturing Practice durante la produzione ed il controllo Applicare le linee guida ICH : Attuale, desiderabile, il futuro Q8 Pharmaceutical development Q9 Quality Risk management Q10 Pharmaceutical Quality System Q11 Development and Manufacture of Drug Substances (chemical entities and biotechnological/biological entities)

5 Oltre le Good Manufacturing Practice? Esempi : Q10 Pharmaceutical Quality System

6 3.1.1 Pharmaceutical Development - Q10 The goal of pharmaceutical development activities is to design a product and its manufacturing process to consistently deliver the intended performance and meet the needs of patients and healthcare professionals, and regulatory authorities and internal customers requirements. Con quale sistema di qualità Non obbligatoriamente in GMP, ma con un sistema di qualità strutturato

7 3.1.1 Pharmaceutical Development - Q10 Approaches to pharmaceutical development are described in ICH Q8. The results of exploratory and clinical development studies, while outside the scope of this guidance, are inputs to pharmaceutical development Con quale sistema di qualità e organizzato trasversalmente fra le varie discipline aziendali interessate (Medicinal Chemistry, Tox, Clinical Development, Pharmaceutical Development) e che conoscono i processi e le normative applicabili

8 Incominciando dalla sintesi del principio attivo Q11 Q11 provides guidance on what information should be provided on product and process development and where this information could be presented. Enhanced approach In an enhanced approach, risk assessment and scientific knowledge are used to select process parameters and unit operations that impact critical quality attributes (CQAs) for evaluation in multivariant DOE studies to establish any design space(s) and control strategies applicable over the lifecycle of the drug substance.

9 Incominciando dalla sintesi del principio attivo Q11 Q11 provides guidance on what information should be provided on product and process development and where this information could be presented. The guideline does not apply to contents of submissions for drug products during the clinical research stages of drug development. However, the principles in this guideline are important to consider during those stages as well.

10 Drug Substance Quality Link to Drug Product The intended quality of the drug substance is determined through consideration of its intended use in the drug product as well as from knowledge and understanding of its physical, chemical, biological, and microbiological properties or characteristics. The characteristics of the drug substance can influence the development of the drug product (e.g., the solubility of the drug substance can affect the choice of dosage form). The Quality Target Product Profile (QTPP) and potential Critical QualityAttributes (CQAs) of the drug product can help identify potential CQAs of the drug substance. Knowledge and understanding of the QTPP and critical quality attributes evolve during the course of development.

11 Per arrivare al Pharmaceutical Development Information from pharmaceutical development studies can be a basis for quality risk management. It is important to recognize that quality cannot be tested into products; i.e., quality should be built in by design. Changes in formulation and manufacturing processes during development and lifecycle management should be looked upon as opportunities to gain additional knowledge and further support establishment of the design space..

12 Per arrivare al Pharmaceutical Development A greater understanding of the product and its manufacturing process can create a basis for more flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided in the registration application. It is the knowledge gained and submitted to the authorities, and not the volume of data collected, that forms the basis for science- and risk-based submissions and regulatory evaluations. Nevertheless, appropriate data demonstrating that this knowledge is based on sound scientific principles should be presented with each application.

13 Pharmaceutical development should include, at a minimum, the following elements: Defining the quality target product profile1 (QTPP) as it relates to quality, safety and efficacy, considering e.g., the route of administration, dosage form, bioavailability, strength, and stability Identifying potential critical quality attributes1 (CQAs) of the drug product, so that those product characteristics having an impact on product quality can be studied and controlled Determining the critical quality attributes of the drug substance, excipients etc., and selecting the type and amount of excipients to deliver drug product of the desired quality Selecting an appropriate manufacturing process Defining a control strategy

14 Using the enhanced product and process understanding in combination with quality risk management to establish an appropriate control strategy which can, for example, include a proposal for a design space(s) and/or real-time release testing

15 Oltre le Good Manufacturing Practice

16 Come mettere in pratica questi strumenti Superando blocchi culturali Compartecipazione delle diverse competenze aziendali Coinvolgimento del senior management Collaborazione con le Autorità regolatorie

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