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Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -9 Question 1: What is robustness, and when should its evaluation be considered? Answer 1: Robustness is the measure of an analytical procedure’s reliability with respect to deliberate variations in method parameters. Its evaluation should be considered during the development phase of the procedure….

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Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -8 Question 1: What validation approach can be used to validate an estimated value for the detection limit? Answer 1: An estimated value for the detection limit can be validated by the independent analysis of a suitable number of samples known to be near…

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Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -7 Question 1: What are the possible approaches for determining the detection limit, and what determines their applicability? Answer 1: The possible approaches for determining the detection limit depend on whether the procedure is non-instrumental or instrumental. Approaches include visual evaluation and signal-to-noise determination….

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Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -6 Question 1: How should accuracy be assessed in the quantitation of impurities? Answer 1: Accuracy should be assessed on samples (drug substance/drug product) spiked with known amounts of impurities. Question 2: What is considered acceptable when it is impossible to obtain samples of…

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Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -5 Question 1: How is the specified range determined in an analytical procedure? Answer 1: The specified range in an analytical procedure is typically derived from linearity studies and depends on the intended application of the procedure. It is established by confirming that the…

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Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -4 Question 1: How can specificity be demonstrated in chromatographic procedures? Answer 1: Specificity in chromatographic procedures can be demonstrated by using representative chromatograms where individual components are appropriately labeled. Critical separations should be investigated, and specificity can be shown by resolving components that…

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Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -3 Question 1: What is the purpose of the ICH Q2 discussed? Answer 1: The purpose of the ICH q2 is to provide guidance and recommendations on how to consider various validation characteristics for each analytical procedure, complementing the parent document which discusses the…

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Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -2 Question 1: What does accuracy of an analytical procedure express? Answer 1: The accuracy of an analytical procedure expresses the closeness of agreement between the value accepted as a true or reference value and the value found. It is sometimes referred to as…

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Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -1 Question 1: What is the objective of validation of an analytical procedure according to the ICH Q2? Answer 1: The objective of validation of an analytical procedure is to demonstrate its suitability for its intended purpose. Question 2: What is the scope of…

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Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -10 Question 1: What is the purpose of management review regarding process performance and product quality? Answer 1: The purpose of management review regarding process performance and product quality is to provide assurance that these aspects are managed effectively over the lifecycle of the…

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Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -9 Question 1: How should changes be managed in the pharmaceutical development stage? Answer 1: Changes in the pharmaceutical development stage should be an inherent part of the process and documented accordingly. The formality of the change management process should be consistent with the…

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Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -8 Question 1: What types of actions should be implemented through the CAPA system according to the ICH Q10? Answer 1: The CAPA system should implement corrective actions and preventive actions resulting from the investigation of various issues such as complaints, product rejections, non-conformances,…

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Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -7 Question 1: Why is it important for pharmaceutical companies to implement a system for monitoring process performance and product quality? Answer 1: It is important for pharmaceutical companies to implement such a system to ensure a state of control is maintained. This system…

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Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -6 Question 1: What are the four elements of the pharmaceutical quality system described in the ICH Q10? Answer 1: The four elements of the pharmaceutical quality system described in the ICH Q10 are: Process performance and product quality monitoring system Corrective action and…

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Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -5 Question 1: What is management responsible for regarding resource management according to the ICH Q10? Answer 1: Management is responsible for determining and providing adequate and appropriate resources (human, financial, materials, facilities, and equipment) to implement and maintain the pharmaceutical quality system and…

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Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -4 Question 1: What role does leadership play in ensuring the effectiveness of a pharmaceutical quality system? Answer 1: Leadership is essential for establishing and maintaining a company-wide commitment to quality and for the performance of the pharmaceutical quality system. Question 2: What is…

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Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -3 Question 1: Why is it important for the design, organization, and documentation of the pharmaceutical quality system to be well structured and clear? Answer 1: It is important for the design, organization, and documentation of the pharmaceutical quality system to be well structured…

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Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -2 Question 1: What is the primary aim of implementing a system according to the ICH Q10 guideline? Answer 1: The primary aim of implementing a system, is to ensure the delivery of products with quality attributes suitable to meet the needs of patients, healthcare professionals,…

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Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -1 Question 1: What is the main focus of the Pharmaceutical Quality System (PQS) outlined in the ICH Q10 guideline? Answer 1: The main focus of the Pharmaceutical Quality System (PQS) described in the ICH Q10 guideline is to establish an effective quality management system within…

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