Interdependencies of the different CPPs and.Basis on which the CPPs have been identified (e.g., prior knowledge, scientific first principles, QRM, design of experiment (DoE), and other appropriate experimentation).Risk assessment and experimentation to establish the linkage between potential CPPs and CQAs.Inter-dependencies of the different CQAs.Ĭonsiderations for identifying and documenting CPPs can include the:.Basis on which the CQAs have been developed (e.g., prior knowledge, scientific first principles, and experimentation) and.Link to the patient as described in the QTPP.Severity of harm (safety and efficacy) before taking into account risk control and the rationale for distinguishing CQAs from other quality attributes.It is based on the probability of occurrence and detectability and therefore can change as a result of risk management.Ĭonsiderations for identifying and documenting CQAs can include the: Process parameter criticality is linked to the parameter’s effect on any critical quality attribute.Quality attribute criticality is primarily based upon severity of harm and does not change as a result of risk management.Risk includes severity of harm, probability of occurrence, and detectability, and therefore the level of risk can change as a result of risk management.Relationship between risk and criticality: In some risk management tools, the ability to detect the harm (detectability) also factors in the estimation of risk.” The introduction of ICH Q9 states that “… the protection of the patient by managing the risk to quality should be considered of prime importance.” The QTPP provides an understanding of what will ensure the quality, safety, and efficacy of a specific product for the patient and is a starting point for identifying the CQAs.Īs part of risk assessment, risk analysis, as defined by ICH Q9 is “ the qualitative or quantitative process of linking the likelihood of occurrence and severity of harm. Increase transparency and understanding for regulators and industryĪ. Considerations for Establishing CQAs and CPPs.Ensure quality of the product throughout the product lifecycle.The information developed to determine CQAs and CPPs will help to: The quality target product profile (QTPP) describes the design criteria for the product, and should therefore form the basis for development of the CQAs, CPPs, and control strategy. Scientific rationale and quality risk management (QRM) processes are used to reach a conclusion on what are critical quality attributes (CQAs) and critical process parameters (CPPs) for a given product and process II. WHAT ARE THE POINTS TO CONSIDER FOR CRITICALITY OF QUALITY ATTRIBUTES AND PROCESS PARAMETERS In all cases, good manufacturing practice (GMP) compliance is expected. Using the Quality by Design (QbD) approach does not change regional regulatory requirements but can provide opportunities for more flexible approaches to meet them. The development approach should be adapted based on the complexity and specificity of product and process therefore, applicants are encouraged to contact regulatory authorities regarding questions related to specific information to be included in their application. They are intended to provide clarity to both industry and regulators and to facilitate the preparation, assessment, and inspection related to applications filed for marketing authorizations. The points to consider are not intended to be new guidance. The points to consider are based on questions raised during the ICH Q-IWG training workshop sessions in the three regions.
The ICH Quality Implementation Working Group (Q-IWG) has prepared this Points to Consider document covering topics relevant to the implementation of ICH Q8(R2), Q9, and Q10, which supplement the existing guidance Q8, Q9, and Q10 Questions & Answers and workshop training materials already produced by this group.
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