Liquid Bourne Particle counter (LBPC)

Liquid Bourne Particle counter (LBPC) Objective: To lay down the procedure for Cleaning, Operation, Maintenance, and Analysis of samples using LBP counter. Scope: This SOP is applicable for the Operation, Cleaning, Maintenance and Analysis of LBPC samples in the manufacturing department. Responsibility: Microbiologist / IPQA personnel are responsible for follow the procedure. Accountability: Head – Quality Assurance … Read more

Cartridge filter -Integrity testing of SOP on

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 Close the air vent of … Read more

Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -9

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. … Read more

Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -8

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 … Read more

Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -7

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. … Read more

Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -6

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 … Read more

Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -5

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 … Read more

Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -4

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 … Read more

Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -3

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 … Read more

Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -2

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 … Read more

Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -1

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 … Read more