International Conference on Harmonization (ICH) Quality Implementation Working Group (Q-IWG) has prepared ‘Points to Consider’ covering topics relevant to the implementation of ICH Q8(R2), Q9 and Q10, which is a simplified Technical Requirements for Registration of Pharmaceuticals for Human Use.
The ‘Points to Consider’ are based on questions raised during the ICH Q-IWG training workshop and are not new but intended to provide clarity to both industry and regulators and to facilitate the preparation, assessment and inspection related to applications filed for marketing authorizations which was released in a 16-page document here recently.
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.
Using the Quality by Design (QbD) approach does not change regional regulatory requirements but can provide opportunities for more flexible approaches to meet them. In all cases, GMP compliance is expected.
The 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) are for a given product and process.
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.
The information to determine CQAs and CPPs will help to develop control strategy, ensure quality of the product throughout the product lifecycle and increase product and process knowledge, besides enhance transparency and understanding for regulators and industry to enable evaluate the changes.
According to Q-IWG, the QTPP provides an understanding of what would ensure the quality, safety and efficacy of a specific product for the patient and is a starting point for identifying the CQAs.
As part of risk assessment, risk includes severity of harm, probability of occurrence, and detectability, and therefore the level of risk can change as a result of risk management. Quality attribute criticality is primarily based upon severity of harm and does not change as a result of risk management. The process parameter criticality is based on the probability of occurrence and detectability which could change with risk management, stated the document.
Considerations for documenting CQAs could cover severity of harm before taking into account risk control. A well-developed control strategy will reduce risk and play a key role in ensuring the QTPP is realized.
The lifecycle of the control strategy is supported by Pharmaceutical Development, Quality Risk Management (QRM) and the Pharmaceutical Quality System (PQS) as indicated in the ICH Guidelines ICH Q8(R2), Q9, Q10.
Pharma industry would need devise a control strategy. This is generally developed and initially implemented for production of clinical trial materials. It can be refined for use in commercial manufacture as new knowledge is gained. Changes could include acceptance criteria, analytical methodology, and introduction of real-time release testing.
The Pharmaceutical Quality System (PQS) strengthens the link between the product lifecycle stages, to facilitate the process validation lifecycle approach. Therefore equipment and facilities should be suitably qualified, including computerized systems and the personnel involved in process validation activities should be appropriately trained, stated the document.
The ‘Points to Consider’ are based on questions raised during the ICH Q-IWG training workshop and are not new but intended to provide clarity to both industry and regulators and to facilitate the preparation, assessment and inspection related to applications filed for marketing authorizations which was released in a 16-page document here recently.
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.
Using the Quality by Design (QbD) approach does not change regional regulatory requirements but can provide opportunities for more flexible approaches to meet them. In all cases, GMP compliance is expected.
The 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) are for a given product and process.
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.
The information to determine CQAs and CPPs will help to develop control strategy, ensure quality of the product throughout the product lifecycle and increase product and process knowledge, besides enhance transparency and understanding for regulators and industry to enable evaluate the changes.
According to Q-IWG, the QTPP provides an understanding of what would ensure the quality, safety and efficacy of a specific product for the patient and is a starting point for identifying the CQAs.
As part of risk assessment, risk includes severity of harm, probability of occurrence, and detectability, and therefore the level of risk can change as a result of risk management. Quality attribute criticality is primarily based upon severity of harm and does not change as a result of risk management. The process parameter criticality is based on the probability of occurrence and detectability which could change with risk management, stated the document.
Considerations for documenting CQAs could cover severity of harm before taking into account risk control. A well-developed control strategy will reduce risk and play a key role in ensuring the QTPP is realized.
The lifecycle of the control strategy is supported by Pharmaceutical Development, Quality Risk Management (QRM) and the Pharmaceutical Quality System (PQS) as indicated in the ICH Guidelines ICH Q8(R2), Q9, Q10.
Pharma industry would need devise a control strategy. This is generally developed and initially implemented for production of clinical trial materials. It can be refined for use in commercial manufacture as new knowledge is gained. Changes could include acceptance criteria, analytical methodology, and introduction of real-time release testing.
The Pharmaceutical Quality System (PQS) strengthens the link between the product lifecycle stages, to facilitate the process validation lifecycle approach. Therefore equipment and facilities should be suitably qualified, including computerized systems and the personnel involved in process validation activities should be appropriately trained, stated the document.
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