Cartridge filter -Integrity Testing SOP Objective: To lay down a procedure for integrity testing of the cartridge filter. Scope: This SOP is applicable for integrity testing of cartridge filters in the formulation plant. Responsibility: Production officer / Executive Accountability: The production Head shall be accountable for compliance with SOP. Procedure Pre-Start-up …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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: …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …