SOP for Procedure for Analytical Method Validation and Verification 1.0 OBJECTIVE To establish a documented procedure for Analytical Method Validation and Verification in the Quality Control (QC) Department to ensure analytical methods are suitable for their intended purpose and comply with regulatory requirements. 2.0 SCOPE This SOP applies to all analytical method validation and verification … Read more
SOP for Stability Study of Volumetric Solutions 1.0 Objective To establish a standardized procedure for conducting stability studies of volumetric solutions to determine and assign their shelf life. 2.0 Scope This SOP is applicable to all volumetric solutions prepared and used in the Quality Control Laboratory. 3.0 Responsibility Chemist or above in the QC Laboratory … Read more
SOP for Chemical Analysis of Water Used in Manufacturing 1.0 Objective To establish a standardized procedure for the chemical analysis of water used in manufacturing to ensure compliance with approved specifications. 2.0 Scope This SOP is applicable to the Quality Control Laboratory for performing chemical analysis of water samples used in manufacturing processes. 3.0 Responsibility … Read more
Key checklist of WHO TRS 1044-annex-2 For products that have been filled aseptically, samples should include containers filled at the beginning and end of the batch. Additional samples (for example, taken after critical interventions) should be considered based on risk. For products that have been heat sterilized in their final containers, samples taken should be … Read more
Finishing of Sterile Products WHO GMP Questions 1. Containers should be closed by: A. Random methodsB. Appropriately validated methodsC. Visual inspection onlyD. Manual sealing without validationAnswer: B Questions 2. Containers closed by fusion, such as glass or plastic ampoules, should be: A. Tested in 10% of unitsB. Subject to 100% integrity testingC. Not tested if visually intactD. … Read more
Equipment WHO GMP Questions 1. A conveyor belt should not pass through a partition between a Grade A/B clean area and a lower-grade processing area unless: A. The belt is painted regularlyB. The belt is continuously sterilized (e.g., in a sterilizing tunnel)C. Personnel supervise it constantlyD. The belt is made of stainless steelAnswer: B Questions 2. Equipment … Read more
Premises WHO GMP Questions 1. Grade A and B areas should be designed so that operations can be: A. Conducted only by supervisorsB. Observed from outsideC. Hidden from viewD. Monitored by external cameras onlyAnswer: B Questions 2. All exposed surfaces in clean areas should be: A. Rough and porousB. Smooth, impervious, and unbrokenC. Painted with any coatingD. … Read more
Personnel in clean areas WHO GMP Questions 1. In clean areas, the number of personnel present should be: A. As many as possibleB. Only the minimum requiredC. Determined by convenienceD. Twice the normal staffAnswer: B Questions 2. During aseptic processes, inspections and controls should be conducted: A. Only from inside the clean areaB. As far as possible from … Read more
Blow/fill/seal technology WHO GMP Questions 1. Blow/fill/seal (BFS) units are designed to: A. Only fill pre-formed containersB. Form containers, fill, and seal them in one continuous operationC. Sterilize containers separatelyD. Only seal containers after manual fillingAnswer: B Questions 2. BFS equipment forms containers from: A. Glass sheetsB. Thermoplastic granulateC. Metal alloysD. Pre-sterilized plasticsAnswer: B Questions 3. For aseptic … Read more
Isolator Technology WHO GMP Questions 1. The primary benefit of isolator technology is: A. Faster productionB. Reduced human labor costsC. Decreased risk of microbial contaminationD. More ergonomic operationAnswer: C Questions 2. Isolators help reduce contamination mainly by: A. Increasing temperatureB. Limiting human interventionsC. Using disposable containersD. Increasing product exposureAnswer: B Questions 3. Isolators and transfer devices: A. All … Read more