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
SOP FOR LABORATORY INSTRUMENT QUALIFICATION Objective: To lay down the procedure for Qualification of laboratory instrument / equipment. Scope: This procedure is applicable for the qualification of laboratory instrument /equipment in Quality Control Lab. Responsibility: IT person shall be responsible to provide IT support and implement the data backup policy for electronic data generated by … 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
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