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manufacturing process question and answer pdf28 May manufacturing process question and answer pdf

Deep helical grooves running up the cutter, Answer: A.Deep helical grooves running up the cutter For drug products formulated with preservatives to inhibit microbial growth, is it necessary to test for preservatives as part of batch release and stability testing? A. However, a minimum number of conformance (a.k.a. The following is used in Magnetic chucks Following is an abrasive cutting b) brazing 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. Following process (es) is (are) subset(s) of grinding 89. 2) Explain what is DCR? Jan 7, 2022. Write about the kinds of polarity in Arc Welding. The initial test results exhibiting out-of specification levels of microbes are not disqualified even if subsequent test results are within specifications. Good Manufacturing Practices Question 1: Consider the following statements: A. A. Aluminium, Answer: D.All of the above GATE Question Paper for Production and Industrial Engineering The production of these items is the primary manufacturing activity, and it involves a range of secondary activities such as quality control, maintenance, and logistics. The adjoining metal has higher melting point compare to filler metal. Profile sharpened type, Answer: A.Profile sharpened type For drilling operation, the drill rotates with_____ pressure if job is held on earth. Write short notes on Pressurized and Unpressurized Gating system. In a manufacturing account, the direct costs are largely variable while the factory overhead expenses will tend to be either fixed or semi-variable. MCQs have a number of advantages over traditional examination formats. It is a change request that mentions the issues with the process or material from a supplier and ask for a resolution. Validated analytical methods are needed for testing every batch, including validation batches. tleblower process, the strategy management process) and (2) governance issues arising from audits that are not specifically focused on gover-nance (e.g., audits of the risk management pro-cess, internal control over financial reporting, and fraud risks). a) true However, in economics, capital is defined as a product used for further production. With neat sketches, explain Semi-Centrifugal and Centrifuged Casting process with its. 12) List out some of the examples of factory overhead? No. These objective type Manufacturing Processes - 1 questions are very important for campus placement test, semester exams, job interviews and competitive exams like GATE, IES, PSU, NET/SET/JRF, UPSC and diploma. c) twisting of the object about the arm axis. 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. C. Rotated by single motor and at same speed. A. Question 02: What is the theory of production? The current FDA guidance on APIs (seeguidance for industry ICH Q7 for APIs)also does not specify a specific number of batches for process validation. procedures to help monitor in-process control, including understanding the bioburden challenge to a final sterilization process ( 211.110(a)(6)). Compendial microbiological test methods typically used in association with upstream biotechnology and pharmaceutical production are not capable of detecting this type of bacteria. True, Answer: B.False This analysis can demonstrate that variability attributable to sample location is not significant and that the powder blend is homogenous. The emphasis for demonstrating validated processes is placed on the manufacturers process design and development studies in addition to its demonstration of reproducibility at scale, a goal that has always been expected. Certain modern manufacturing designs (isolators and closed vial filling) afford isolation of the aseptic process from microbiological contamination risks (e.g., operators and surrounding room environment) throughout processing. A. 21 CFR 211.165(b) states that [t]here shall be appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms before it is released for distribution. d) none of the mentioned. It is also not acceptable for manufacturers to allow an inappropriately long time (e.g., weeks) to pass before testing the product, which might permit the preservative to reduce levels of microbes possibly introduced during manufacture and thus avoid out-of-specification test results. startxref 84. A. Tail stock set-over method, 24. Which operation can correct hole location, size or alignment of the hole which is already drilled in workpiece? The location of the food industry should be nearest to the populous area. Explain different types of Rolling Mills. Wrought <.2% Steel .2-2.3% Cast Iron 2.3-4.2% . BASIC MANUFACTURING PROCESSES Basic Manufacturing Processes (NME-101/201). A. What do you know about our company? It is often used in a transaction where a customer returns goods to the manufacturer for replacement or repair purpose. For example, if a firm finds it necessary to hold a bulk topical or liquid product for several months until it is filled, the firm might establish a holding time limit to help prevent objectionable microbial buildup. Manufacturing Industries Class 10 MCQ PDF Download. Labor can be both physical and mental in nature. 18) What are the softwares which can be useful in manufacturing unit? In _____, the cutting action occurs primarily at the end corners of the milling cutter. a) rolling The 7th chapter of our economics learning course is Theory of Production. In this article, well learn the 50 most important theory of production questions and their answers. What are the Agencys recommendations regarding in-process stratified sampling of finished dosage units? B. What specific CGMP regulations might be useful to manufacturers of topical antiseptic drug products? d) molding and plating. See correct answer (a). 9. Clarification: This is false. Use of specialized media such as Ellinghausen McCullough Johnson Harris (EMJH) medium (Ellinghausen and McCullough 1965) or other suitable media (Rule and Alexander 1986). Answer: The law of variable proportions works under the following assumptions: Question 31: What are the different types of returns to a factor? Can containers, closures, and packaging materials be sampled for receipt examination in the warehouse? Why is FDA concerned about human topical antiseptic drug products? What do you know about our business? A. 66. 2012; Matthias, Ricaldi, et al. A. It is considered acceptable practice to display temporary equipment status information on dry-erase boards or chalkboards. In todays world, it doesnt make sense to think that prices for inputs and production methods will stay the same. 8. Required fields are marked *. Do pharmaceutical manufacturers need to have written procedures for preventing growth of objectionable microorganisms in drug products not required to be sterile? To reduce machining time. This methodology is mainly used when similar items are produced together. endstream endobj 71 0 obj <> endobj 72 0 obj <> endobj 73 0 obj <>/Font<>/ProcSet[/PDF/Text]/ExtGState<>>> endobj 74 0 obj <> endobj 75 0 obj <> endobj 76 0 obj [/ICCBased 83 0 R] endobj 77 0 obj <> endobj 78 0 obj <> endobj 79 0 obj <> endobj 80 0 obj <>stream Labels are merely one way to display temporary status information about a piece of equipment. How do I contact CDER with questions aboutPAT? 1 A manufacturing company benchmarks the performance of its accounts receivable department with that of a leading credit card company. This is what increasing returns to scale means. Objective tests can also be an effective teaching tool. chapter: Answer: A short run is a period of time during which the quantities of one or more production factors cannot be changed. c) sheet forming Soft material, Answer: B.Very hard material A. 88. A. 21 CFR 211.113(a) requires appropriate written procedures to be established and followed during manufacturing to prevent objectionable microorganisms in drug products not required to be sterile. 1999). Explain IQC department and warehouse related questions. In lathe, form tools are used to produce According to the modern economys definition of capital, capital includes not only money but also houses, buildings, machinery, furniture, and anything else used for production. Most CNC milling machines are For example, some product considerations for manufacturers include, but are not limited to: 14. Which of the following device is not used for holding the work in a drilling machine? Centers, Answer: C.Work rest Surface hardness, 52. 35 Production Worker Interview Questions (With Answers) b) casting What is mean by Directional solidification? Question 30: What are the assumptions of the law of variable proportions? 68. 6. Hello, Does anyone have a solution for the problem below: We have a library with documents, in the public sharepoint ON-PREMIESE 2016 portal. Saddle, 17. Steady rest, 20. Your email address will not be published. It shows the message below: "Viewing of .pdf MANUFACTURING INDUSTRIES SHORT ANSWER TYPE QUESTIONS [3 MARKS] 1. establish control procedures to monitor output and validate processes to include bioburden testing ( 211.110(a)(6)), 211.111) and establish and follow written procedures designed to prevent the introduction of objectionable microorganisms ( 211.113(a)). Yes, CGMP regulations do require these written procedures. chapter: Dear Readers, Welcome to Manufacturing Processes - 1 multiple choice questions and answers with explanation. A is correct B is correct Both A and B Neither A nor B Answer: Increasing returns to a factor means that when more and more units of a variable factor are added to a fixed factor of production, the output goes up by a larger percentage. 4. Write short notes on Plastic Blow Molding. Additive process: C. Formative process: D. All of above: Answer A. Subtractive process The firm will continue monitoring for Mycoplasma and has revalidated their cleaning procedure to verify its removal. Casting includes grinding process. 72. Question 13: What are the variable factors? 490.100 on Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval. Following coating(s) is (are) for milling cutters Main challenge in manufacturing is to develop better production processes, ensure the right material and component supplies at the least cost, decrease production time, eliminate wastage and maintain quality in the final product. 0000002376 00000 n Determine the types of microbes that might survive or thrive in your products. Pitch, 26. Clarification: In machining process, some raw material is wasted in or in order to perform different operations like drilling, turning etc. 59. If one of the variable factors changes, the level of output will also change. A. Countershaft, ---- >> Below are the Related Posts of Above Questions :::------>>[MOST IMPORTANT]<, Your email address will not be published. We expect that validated and well-controlled processes will achieve fairly consistent waste amounts batch-to-batch. The Agency acknowledges that the idea of three validation batches became prevalent in part because of language used in past Agency guidance. establish and follow written procedures designed to. Thus the tutor can indicate the correct solution and also explain or seek responses as to why other plausible answers are incorrect to the given statement. In which type of operation, motion of cutting tool is translating? The land is an infinite resource that can never be depleted. However, it has a specific meaning when used in economics. 8. This allows the examiner to mark candidates' responses in an objective rather than subjective fashion. For example, the capital and the manager cant be split up to fit a small production. Length of the stroke can be varied in In this way, the relationship between inputs and outputs is tested by changing all the factors of production at the same time and in the same way. 3. The following is used for holding bored parts for machining their outside surfaces onLathe. 78. Answer: In economics, the supply of a variable factor is elastic in the short run. Powder metallurgy is a process in which material or shapes are made from or by using metal powders. FDAs major concern was that sections V and VII of the withdrawn draft guidance no longer represented the Agencys current thinking, as explained below. Tapping attachment is included in_______ method of tool holding devices. 211.84)(d)(4-5), including applicator material (e.g., cotton pads) and water used as an ingredient in the product. How do I contact CDER with questions about PAT? Here are 1000 Manufacturing Processes MCQ (Chapterwise). In cylindrical grinder, how many centers hold the workpiece? Do the CGMP regulations require a firm to retain the equipment status identification labels with the batch record or other file? Portable drilling machine, 42. 77. Following milling machine is used to cut gears Even though a drug product is not sterile, a firm must follow written procedures that proactively prevent introduction and proliferation of objectionable microorganisms. For example, man has increased the utility of things provided by nature by creating chairs, tables, and other furniture out of trees and clothing out of cotton. It is generally not acceptable from a CGMP perspective for a manufacturer of sterile drug products produced by aseptic processing to rely solely on ISO[International Organization for Standardization]14644-1 Part 1: Classification of Air Cleanliness (14644-1) and ISO 14644-2 Part 2: Specifications for Testing and Monitoring to Prove Compliance with ISO 14644-1 (14644-2) when qualifying its facility. A. drilling and milling, 108. 94. c) Mixture of copper oxide and zinc oxide. b) casting process Answer: b 9. Finally, drug manufacturers should review their manufacturing process to determine procedures or equipment that might introduce contaminating microorganisms into the process or product. B. Rotated by separate motors and at same speed.

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