Preguntas y respuestas sobre ICH Q8 Q9 y Q10
Mayo 29th, 2009
En abril de este año la ICH ha adoptado de manera oficial un documento de Q&A emitido por el Implementation Working Group IWG. Este grupo fué creado en noviembre de 2007 para velar por que la implantación de estas guías se realice de forma coordinada y sacando el máximo beneficio de la interacción entre ellas.
En la línea de clarificar conceptos va este documento de trabajo que seguramente ayudará a despejar algunas dudas. Consultar el documento aqui
A continuación adjuntamos unas tablas que resumen algunos puntos clave clasificados por temas: design space-real time release-control strategy-GMP inspection practices-software solutions.
DESIGN SPACE
| Question | Answer |
| Is it always necessary to have a Design Space (DS) or Real Time Release (RTR) testing to implement QbD? | Under Quality by Design, establishing a design space or using real time release testing is not necessarily expected |
| Is it possible to develop a design space for existing products? | Yes, it is possible. For manufacturing operations run under narrow operational ranges in fixed equipment, an expanded region of operation and an understanding of multi-parameter interactions may not be achievable from existing manufacturing data alone and additional studies may be needed to develop a design space. |
| Can a design space be applicable to scale-up?Can a design space be applicable to a site change?Can a design space be developed for single and/or multiple unit operations? | Yes, when appropriately justified and documented. |
REAL TIME RELEASE
| Question | Answer |
| Does real time release testing mean elimination of end product testing? | Not necessarily. An applicant may propose RTR testing for some attributes only or not all. If all CQAs (relevant for real time release testing) are assured by in-process monitoring of parameters and/or testing of materials, then end product testing might not be needed for batch release. |
| Is a product specification still necessary in the case of RTR testing? | Yes, product specifications [see ICH Q6A and Q6B] still need to be established and met, when tested. |
| What is the relationship between Control Strategy and RTR testing? | RTR testing, if utilized, is an element of the Control Strategy in which tests and/or monitoring can be performed as in process testing (in-line, on-line, at-line) rather than tested on the end product. |
| If RTR testing results fail or trending toward failure, can end-product testing be used to release the batch? | No, in principle the RTR testing results should be routinely used for the batch release decisions and not be substituted by end-product testing. The batch release decision needs to comply with the content of the marketing authorisation and GMP compliance. |
CONTROL STRATEGY
| Question | Answer |
| What is the difference in a control strategy for products developed using the minimal approach vs. ‘quality-by-design’ approach? | Control strategies are expected irrespective of the development approach. For products developed following the minimal approach the control strategy is usually derived empirically and typically relies more on discrete sampling and end product testing. Under QbD, the control strategy is derived using a systematic science and risk-based approach. Testing, monitoring or controlling is often shifted earlier into the process and conducted in-line, on-line or at-line testing. |
| Are GMP requirements different for batch release under QbD? | No, the same GMP requirements apply for batch release under minimal and QbD approaches. |
| What is the relationship between a Design Space and a Control Strategy? | A control strategy is required for all products. If a Design Space is developed and approved, the Control Strategy [see ICH Q8(R1), Part II, Section 4] provides the mechanism to ensure that the manufacturing process is maintained within the boundaries described by the Design Space. |
GMP INSPECTION PRACTICES
| Question | Answer |
| How will product-related inspections differ in an ICH Q8, Q9 and Q10 environment? | Greater collaboration between inspectors and assessors for example for the assessment of development data. Greater focus on enhanced process understanding and understanding relationships e.g., Critical Quality Attribute (CQAs), Critical Process Parameters (CPPs). It will also extend into the application and implementation of quality risk management principles, as supported by the Pharmaceutical Quality System (PQS). |
| How will system-related inspections differ in an ICH Q8, Q9 and Q10 environment? | Inspections will have greater focus (but not only) on how the PQS facilitates the use of e.g., Quality Risk Management methods, implementation of design space and change management [see ICH Q10]. |
SOFTWARE SOLUTIONS
| Question | Answer |
| Is a specific dedicated computerised information management system required for the implementation of knowledge management with respect to ICH Q8, Q9 and Q10? | No, but such computerised information management systems can be invaluable in capturing, managing, assessing and sharing complex data and information. |
| A number of commercial vendors are now offering products that are being marketed as ‘ICH compliant solutions’ or ICH Q8, 9 & 10 Implementation software, etc. Is it necessary for a pharmaceutical firm to purchase these products | No. While there will likely be a continuous proliferation of new products targeting the implementation of these ICH guidelines, firms will need to carry out their own evaluation of these products relative to their business needs. |
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