Pharmaguidances Aseptic process simulation (APS)/ media fill questions EUGMP- Annex-1 Questions 1. What is another name for an Aseptic Process Simulation (APS)? A. Sterility testB. Media fillC. Endotoxin challengeD. Cleaning validationAnswer: B Questions 2. What is the purpose of periodic APS? A. To replace routine monitoringB. To verify the effectiveness of controls for aseptic processingC. To … Read more
Questions and Answers on Quality Control (QC) Questions 1. QC personnel supporting sterile manufacturing activities must have training and experience in: A. Marketing and financeB. Microbiology, sterility assurance, and process knowledgeC. Mechanical engineering onlyD. Warehouse operationsAnswer: B Questions 2. Specifications for raw materials, components, and products should include limits for: A. Moisture onlyB. Microbial, particulate, … Read more
Multiple-Choice Questions (MCQs) & answer on cleaning validation Considering Packaging Materials & Tubing and Hoses Questions 1: Which of the following is a primary consideration before using tubing or hoses in pharmaceutical manufacturing? A. Color of the tubing B. Biocompatibility and inertness with the contact material C. Cost of the tubing D. Manufacturer’s brand name Answer: … Read more
Multiple-Choice Questions (MCQs) & answer on cleaning validation Objective-Type Questionnaire 1.Question : According to the 1993 U.S. FDA cleaning validation guidance, cleaning validation is not required when the cleaning process is used:A. Between batches of different products on multipurpose equipmentB. Only between batches of the same productC. Between batches of high-potency pharmaceuticalsD. For any dedicated … Read more
Questions and Answers on Validation Master Plan (VMP) Questions 1. The VMP should be: A. Very detailed and lengthyB. Brief, concise, and clearC. A replacement for all SOPsD. Written only by external auditorsAnswer: B Questions 2. The VMP should not repeat information already documented elsewhere; instead, it should: A. Omit referencesB. Refer to existing documents … Read more
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ProtiASP – Protein Powder in Pista Badam Flavour ProtiASP – Protein Powder (Pista Badam Flavour) Specially Formulated Nutritional Supplement for Pregnant & Lactating Mothers Specially Formulated Nutritional Supplement for Pregnant & Lactating Mothers ProtiASP – Protein Powder (Pista Badam Flavour) offers a nutritionally complete, palatable, and safe supplement for expectant and lactating mothers. It bridges … Read more
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