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
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
Aseptic Processing and Sterilization by Filtration WHO GMP Question 1. The main objective of aseptic processing is to: A. Reduce product costB. Maintain sterility of assembled componentsC. Improve product colorD. Increase viscosityAnswer: B Question 2. Aseptic processing must operate under conditions that: A. Encourage microbial growthB. Prevent microbial contaminationC. Maximize airflowD. Reduce temperatureAnswer: B Question 3. … Read more
Terminal Sterilization WHO GMP Question 1. Heat-sterilization cycles should be recorded using: A. Visual inspectionB. Time/temperature chartC. Sound alarmsD. Pressure onlyAnswer: B Question 2. Temperature during heat sterilization should be measured at: A. The hottest partB. The center of the chamber onlyC. The coolest part of the loadD. The chamber wallsAnswer: C Question 3. The coolest … Read more
Sterilization WHO GMP Question 1. Preferred sterilization method for sterile products is: A. FiltrationB. Aseptic filling onlyC. Terminal heat sterilization in final containerD. UV irradiationAnswer: C Question 2. Terminal heat sterilization may be avoided when the product: A. Is too expensiveB. Is unstable to heatC. Is stored in glass containersD. Has low viscosityAnswer: B Question 3. … Read more
Terminally Sterilized Products WHO GMP Question 1. Components for terminally sterilized products should be prepared in at least:A. Grade AB. Grade BC. Grade CD. Grade DAnswer: D Question 2. Preparation should occur in Grade C when the product:A. Has low microbial riskB. Is stable for long storageC. Actively supports microbial growthD. Is a solid tabletAnswer: … Read more
Manufacture of Sterile Preparations Question 1. Clean areas for sterile product manufacture are classified according to: A. Equipment costB. Required environmental characteristicsC. Number of personnelD. Type of raw materialAnswer: B Question 2. The purpose of environmental cleanliness classification is to minimize: A. Energy consumptionB. Packaging costC. Particulate or microbial contaminationD. Airflow noiseAnswer: C Question 3. … Read more