manufacturing process question and answer pdf
What does objectionable mean anyway? 18) What are the softwares which can be useful in manufacturing unit? Candidates will be able to download GATE PI 2023 Question Paper after the completion of the exam on Feburary 11, 2023 (Afternoon Session). limited ability to substitute one factor for another because labor and capital are insufficient replacements. 490.100 on Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval. A. true, 110. A. Can Leptospira species penetrate sterilizing-grade filters? View Answer. The information on the temporary status label should correspond with the information recorded in the equipment cleaning and use log, or the previous batch record for nondedicated equipment. However, a minimum number of conformance (a.k.a. Traditional sampling using a powder-thief may have drawbacks and limitations, such as causing disturbance to the powder bed, powder segregation, or other sampling errors. 69. Normally, media fills should be repeated twice per shift per line per year. In cylindrical grinder, how many centers hold the workpiece? A. true, 33. 0000000985 00000 n It is often used in a transaction where a customer returns goods to the manufacturer for replacement or repair purpose. 104. 1.What is a lathe? Shaping machine, Answer: D.All of these The axial advancement in one rotation of the screwed part is known as ____ of the threads. In March 2004, FDA revised the Compliance Policy Guide (CPG) Sec. Diseconomies of scale are the root cause of diminishing returns to scale. 2008; Bharti, Nally, et al. Even though a drug product is not sterile, a firm must follow written procedures that proactively prevent introduction and proliferation of objectionable microorganisms. The Lathe carriage serves the following purpose of the tool No. Answer ALL questions 1. Increases in labor wages frequently reduce rather than increase the labor supply. These include labor, raw materials, and so on. marginal product = (difference in total products/difference in variable input). Shaping machine only, Answer: D.All of the above Process Automation. Question 13: What are the variable factors? It is assumed that technology will stay the same. Application crashes when trying to generate a pdf. Answer: The iso-cost line shows the different combinations of two production factors that a firm can buy with a certain amount of money. For example, some product considerations for manufacturers include, but are not limited to: 14. A milling cutter may have surfaces made of CGMP inspections by a PAT-certified investigator can precede or follow PAT implementation. This is one way we can change how the factor is put together and see how it affects the output. PDF Animal Care Program b. Some inputs, like machinery, management skills, and so on, can only be used for a certain size of production. 2) Explain what is DCR? Which of the following method is not used for holding tool? This rule doesnt work when every factor is different. 0000004038 00000 n Answer: All of the components that go into making a product is referred to as factors of production. The following are important production factors: Answer: The first and most important component of production is the land. Worm, Answer: D.All of the above Manufacturers should contact the Office of Pharmaceutical Quality and/or the appropriate review division in CDER to discuss applicability of PAT to CDER-regulated products. A. Cylindrical surfaces, C. The surfaces which are neither cylindrical nor tapered, Answer: C.The surfaces which are neither cylindrical nor tapered, 29. The primary meaning relates to microbial contaminants that, based on microbial species, numbers of organisms, dosage form, intended use, patient population, and route of administration, would adversely affect product safety. Manufacturing Processes - 1 - Mechanical Engineering (MCQ) questions A. Such procedures shall include validation of all aseptic and any sterilization process. All the following are true regarding DBR except: a) It is both a push and pull system. 10) List out the factors that can affect the manufacturing process? With neat sketches, explain Semi-Centrifugal and Centrifuged Casting process with its. Determine the types of microbes that might survive or thrive in your products. A. C. Basic oxygen process . Slope of the iso-cost line = (labor cost/capital cost). A. Boring, 41. A. Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval, ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Process Validation: General Principles and Practices, U.S. Food and Drug Administration Web site, International Organization for Standardization Web site, Sterile Drug Products Produced by Aseptic ProcessingCurrent Good Manufacturing Practice, Current Good Manufacturing Practice for Finished Pharmaceuticals, Pre-operational Reviews of Manufacturing Facilities, Sterile Drug Products Produced by Aseptic ProcessingCurrent Good Manufacturing Practice, FDA Reminds Health Care Professionals About Safe Use of Non-Sterile Alcohol Prep Pads, Sampling and testing of in-process materials and drug products, General requirements [Laboratory Controls], Testing and release [of the finished drug product] for distribution, PATA Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, Control of Components and Drug Product Containers and Closures, 21 CFR 211.182: Equipment cleaning and use log, 21 CFR 211.105: Equipment identification, 21 CFR 211.84: Testing and approval or rejection of components, drug product containers, and closures, 21 CFR 211.94: Drug product containers and closures, 21 CFR 211.113(b): Control of microbiological contamination, 21 CFR 211.122: Materials examination and usage criteria, 21 CFR 211.113: Control of microbiological contamination, 21 CFR 211.84(d)(6): Testing and approval or rejection of components, drug product container, and closures, Sundaram, S, J Eisenhuth, G Howard, and H Brandwein, 1999, Application of Membrane Filtration for Removal of Diminutive Bioburden Organisms in Pharmaceutical Products and Processes, PDA J Pharm Sci Technol, 53(4):186201, Kong, F, G James, S Gordon, A Zekynski, and GL Gilbert, 2001, Species-Specific PCR for Identification of Common Contaminant Mollicutes in Cell Culture, Appl Environ Microbiol, 67(7):31953200, Murray, P, E Baron, M Pfaller, F Tenover, and R Yolken, 1995, Manual of Clinical Microbiology, 6th ed., Washington, DC: ASM Press, ISO 14644-1 Part 1: Classification of Air Cleanliness, ISO 14644-2 Part 2: Specifications for Testing and Monitoring to Prove Compliance with ISO 14644-1, FDA Guidance for Industry, 2004, PATA Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, 21 CFR 211.63:Equipment design, size, and location, 21 CFR 211.67: Equipment cleaning and maintenance, 21 CFR 211.84(c)(3), which states that "Sterile equipment and aseptic sampling techniques shall be used when necessary. Please submit your suggestions and detected errors to Jeetender Singh Kushawaha 9450935651 (k .jitendrasingh@yahoo.com) 1 Updated 07 July 2013 BASIC MANUFACTURING PROCESSES Questions and answers A. 5) Explain what is Six Sigma? The process of chamfering the entrance of a drilled hole is known as_____ Clarification: Only rolling, forging and sheet forming are included in forming and shaping process. 15. Answer: a There are three different kinds of returns to scale, which are: Question 39: What are the increasing returns to scale? The CGMP regulations provide the minimum legal requirements for conducting reliable operations (see 21 CFR part 211). Questions and Answers on Current Good Manufacturing Practice The investigation was not successful in isolating or recovering the contaminating organism using conventional microbiological techniques, including the use of selective (e.g., blood agar) and nonselective (e.g., TSB and tryptic soy agar) media, and examination under a microscope. There can be no intersection of two isoquants. Please use the space provided on the inside cover of the Candidate Answer Booklet to indicate your chosen answer to each multiple choice question. Manufacturing Technology 1 Lab Viva Questions and answers It implies that a commodity can only be produced using a single method. In cutting Right hand threads, the spindle and lead screw rotates in the A firm had multiple media fill failures. 7) Explain what is QMS? Does CGMP regulations require three successful process validation batches before a new active pharmaceutical ingredient (API) or a finished drug product is released for distribution? On drilling machine, which process is known as reaming? Large number of cutting tools can be simultaneously used in. This is most pronounced for processes involving lamination of rolls of various component layers. Explain their causes, Do not sell or share my personal information. 20) Explain what are the approach used in manufacturing for QA? b) mechanical joining Which of the following operation, we cant perform on drilling machine? The location of the food industry should be nearest to the populous area. BASIC MANUFACTURING PROCESSES Basic Manufacturing Processes (NME-101/201). In which type of operation, motion of cutting tool is translating? 2003). Answer: A.Rotated by separate motors and at different speeds. Question 28: What is the average product? How do I contact CDER with questions aboutPAT? The term "production" has a specific meaning in economics. 7. 0000003582 00000 n Controlled the entire steel making process from mining to . The effect of setting a boring tool above center height leads to Answer: Iso-cost line is a straight line that intersects both axes (x and y). 58. 45. Required fields are marked *. It depends on the cause and consistency of the reject rate. It is considered acceptable practice to display temporary equipment status information on dry-erase boards or chalkboards.
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