%PDF-1.4 % Answer: Negative returns to factors are when an increase in a variable factor causes the total output to go down. Answer: b For drilling, the drill is rotated with a downward pressure causing the tool to penetrate into the material. This style of examination question has recently been adopted by the Institute of Chartered Accountants in Ireland and is also used in third level institutions. chapter: d) molding and plating. A. Is the same frequency expected of a process conducted in an isolator? b. a) rolling 211.84)(d)(4-5), including applicator material (e.g., cotton pads) and water used as an ingredient in the product. In how many groups, various metal working processes can be classified? This lower total number of media fill runs would be based on sound risk rationale and would be subject to reevaluation if contamination issues (e.g., product nonsterility, media fill failure, any problematic environmental trends) occur. It implies that a commodity can only be produced using a single method. Answer: Iso-cost line is a straight line that intersects both axes (x and y). Enter the email address you signed up with and we'll email you a reset link. Forming and shaping type process include the process like drawing. With neat sketches, explain Semi-Centrifugal and Centrifuged Casting process with its. Exactly on a, 23. Document and implement any corrective actions deriving from the evaluation ( 211.192). 16. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. This is what increasing returns to scale means. Answer: Constant returns to scale are said to happen in productive activities where the factors of production are perfectly divisible. Grinding is commonly used on A. Mandrel, 19. Most Asked Technical Basic CIVIL | Mechanical | CSE | EEE | ECE | IT | Chemical | Medical MBBS Jobs Online Quiz Tests for Freshers Experienced . PDF Manufacturing Interview Questions - Skillful Question 14: What is the production function? A. Well-written and followed procedures are the critical elements. In a manufacturing account, the direct costs are largely variable while the factory overhead expenses will tend to be either fixed or semi-variable. 102. 9. 4) Explain what is MES? a) casting b) forming and shaping c) machining d) joining Answer: b Clarification: Forming and shaping process includes powder metallurgy. Flat surface can be produced in Click to reveal I hope you have a good understanding of the Theory of Production chapter by the end of this post. Section 211.165(f) mandates that drug products failing to meet established standards or specifications be rejected. A. drilling and milling, 108. Thanks you so much for this, Your email address will not be published. 10. A. Aluminium, Answer: D.Cast Iron Answer: D.To avoid buckling A multiple choice questionnaire (MCQ) style examination typically consists of 20/30 short statements, each of which is followed by a number of alternative answers. Built to bore holes, C. Typically bed mills with a long spindle throw, Answer: D.All of the above If a scientifically sound PAT monitoring and control strategy is established, it can facilitate the assessment of (a) variability across locations within the powder bed (El-Hagrasy, Morris, et al. B. Rotated by separate motors and at same speed. Diseconomies of scale are the root cause of diminishing returns to scale. 0000000016 00000 n b. The CGMP regulations in 21 CFR parts 210 and 211 for finished pharmaceuticals apply equally to over-the-counter (OTC) and prescription (Rx) drug products (see Compliance Policy Guide Sec. A. ASTM Standard E2709, 2014, Standard Practice for Demonstrating Capability to Comply with an Acceptance Procedure, West Conshohocken, PA: ASTM Standard E2810, 2011, Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units, West Conshohocken, PA: 21 CFR 211.165: Testing and release for distribution, USP 38National Formulary (NF) 33 (2015) General Chapter <51> Antimicrobial Effectiveness Testing, USP 38NF 33 (2015) General Chapter <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests, USP 38NF 33 (2015) General Chapter <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms, React with, or potentially damage the integrity of, the container closure system (for example, fermentation that creates gaseous pressures sufficient to rupture a product container/closure), Interfere with analytical methods or active ingredient bioavailability, 21 CFR 211.111: Time limitations on production, USP 38NF 33 (2015) General Chapter <51> Antimicrobial Effectiveness Testing. Yes. Answer. A. Powder metallurgy is a process in which material or shapes are made from or by using metal powders. It typically occurs as production size grows and managerial effectiveness declines, slowing the rate of output growth. A. upward, 38. Because of this, output goes up by the same amount as the number of factors of production. As such, FDA adopted these particle cleanliness ratings in the 2004 guidance for industry Sterile Drug Products Produced by Aseptic ProcessingCurrent Good Manufacturing Practice. In drilling operation, work should be held by hand. 71. b) forging Thanks Clarification: In machining process, some raw material is wasted in or in order to perform different operations like drilling, turning etc. Finally, drug manufacturers should review their manufacturing process to determine procedures or equipment that might introduce contaminating microorganisms into the process or product. Which operation can correct hole location, size or alignment of the hole which is already drilled in workpiece? d) joining. It can be obtained by dividing the total output by the total number of units of factor employed. Answer: In economics, the supply of a variable factor is elastic in the short run. Please refer to ASTM E2709 and ASTM E2810 for further guidance on establishing acceptance criteria for a stratified sampling plan. Which of the following processes are included in finishing? References: 19. Yes, CGMP regulations do require these written procedures. Following are the overheads aproductionmanufacturing engineer has to consider: Supervising a manufacturing process includes attending to the individual phases of the production. The topics covered in each chapter are logically sequenced so that as the student progresses through the chapter they build up their knowledge and skills in relation to that topic. Deep helical grooves running up the cutter, Answer: A.Deep helical grooves running up the cutter Answer: There are three types of returns to a factor, which are as follows: Question 32: What are the increasing returns to factor? It has been shown that Acholeplasma laidlawii is capable of penetrating a 0.2 micron filter, but is retained by a 0.1 micron filter (see Sundaram, Eisenhuth,et al. 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. Brazing is a type of metal joining process. Guiding, 16. A. turning, 106. Currently, there are several standard statistical practices that, if used correctly, can help to ensure compliance with CGMP regulations, including 21 CFR 211.110, 21 CFR 211.160, and 21 CFR 211.165. 7. Answer: The production function is a set of rules that shows how the inputs and outputs of factors are related. Line AB shows the iso-cost line. 104. Answer: a 18. Answer: The following are the key features of isoquant: Answer: The linear isoquant model assumes that all production factors are perfectly substitutable. c) coating and milling ADO.NET Entity Framework Interview Questions, Microsoft OFFICE :- More Interview Questions, Equity Trading & Dealer Interview Questions, Computer System Analyst (Software) Interview Questions, DATA ANALYTICS :- More Interview Questions, Oracle Warehouse Builder Interview Questions, Business Intelligence :- More Interview Quetions, Administrative Assistant Resume & Cover Letter, Manufacturing Production Interview Questions. 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). Only one answer is strictly correct. Hence , at the begining of industry 4.0 implementation . Only one answer is strictly correct. But whether the act of collecting a sample in the warehouse violates the CGMP requirement that containers "be opened, sampled, and sealed in a manner designed to prevent contamination of their contents" will depend on the purported quality characteristics of the material under sample and the warehouse environment. Determine the types of microbes that might survive or thrive in your products. A. Your email address will not be published. How can I implement PAT (process analytical technology)? Normally, media fills should be repeated twice per shift per line per year. Headstock, tailstock, carriage, crossslide, toolpost Answer: Producer equilibrium is when a producer makes a certain amount of output by putting together the factors that cost the least. 89. Examples include: a. A. planning, 109. Question 03: What are the factors of production? Required fields are marked *. In general, capital means money invested in a business. One, Answer: B.Two 70. Write short notes on Plastic Blow Molding. Use of specialized media such as Ellinghausen McCullough Johnson Harris (EMJH) medium (Ellinghausen and McCullough 1965) or other suitable media (Rule and Alexander 1986). 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. Answer: The total product is the sum of all the goods and services that a company makes with a certain number of inputs. In centerless grinding, workpiece is supported by 98. Question 35: What are the factors behind the law of returns? A. 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. c) twisting of the object about the arm axis. All the following are true regarding DBR except: a) It is both a push and pull system. Is the same frequency expected of a process conducted in an isolator? The waste is usually due to the cumulative effect of roll splicing, line start-ups and stoppages, roll-stock changes, and perhaps higher rates of in-process sampling. In manufacturing unit, software that can be useful are Manufacturing ERP and Material Management. Because they cant be split up, these factors must be used in a minimum amount, even if the production scale is small. a) machining process Once a supplier's reliability has been established by validation of their test results, a manufacturer could perform the visual examination entirely in the warehouse. Labor is a finite resource that cannot be sustained. 6. In this case, as a business increases its output, the cost per unit starts going down. b) casting process How can manufacturers assess and address the risk of microbiological contamination of topical antiseptics? However, powder-thief sampling remains widely used and provides reliable results in many cases. 1. Breaking of joint is not necessary in this case. Clarification: This is false. 15. In this case, a thorough investigation by the firm led to a determination of the cause of the failure and an appropriate corrective action. What is broaching? Question 44: What are the causes of diminishing returns to scale? Some of the companies that provide the manufacturing software solution are SAP, Oracle ERP system, etc. This should not of itself be a concern. Contact for further information:CBER Key Staff Directory. In electrochemical grinding, the pieces from the workpiece Additive process: C. Formative process: D. All of above: Answer A. Subtractive process b) casting b. Answer: The law of variable proportions works under the following assumptions: Question 31: What are the different types of returns to a factor? The adjoining metal has higher melting point compare to filler metal. The work-table can rotate in A. Planers, Shapers and Slotters They conducted their media fills using TSB (tryptic soy broth) prepared by filtration through a 0.2 micron sterilizing filter. 6) What is the difference between lean manufacturing and JIT (Just-in-Time) Manufacturing? If the amount of variable factor used is less than what is best, the fixed factor isnt being used to its full potential, which lowers the productivity of the variable factor. a. However, it has a specific meaning when used in economics. PDF BAA Call N00014-23-S-BC05 Amendment 0003 Special Program Announcement Because of this effect, increasing returns to scale happen. 13) Explain how to supervise in a manufacturing unit? FDAwithdrew its draft guidance for industry on Powder Blends and Finished Dosage UnitsStratified In-Process Dosage Unit Sampling and Assessment. M|I(ja$RWY%:M. A. 56. 21. Question 30: What are the assumptions of the law of variable proportions? Candidates will be able to download GATE PI 2023 Question Paper after the completion of the exam on Feburary 11, 2023 (Afternoon Session). MANUFACTURING INDUSTRIES SHORT ANSWER TYPE QUESTIONS [3 MARKS] 1. For example, because coal deposits are limited, doubling the size of a coal mine may not double the amount of coal that can be mined. View Answer. Sorry, preview is currently unavailable. Write short notes on Plastic Blow Molding. a) CAD and CAM b) drafting and documentation c) documentation and geometric modeling d) none of the mentioned View Answer 2. In which of the following machine, the work rotates and the tool is stationary? Answer: The law of variable proportions has the following limits: Question 37: What are the returns to scale? Answer: The ratio of input prices is shown by the slope of the iso-cost line. Establish and follow in-process bioburden testing. Cloudflare Ray ID: 7d1329fa5d1d6665 However, we are providing this communication to alert manufacturers that these types of bacteria can potentially: As a general principle, manufacturers should use sound risk management and be aware of unusual microbiota reported in the literature that may impact their manufacturing processes (e.g., cell culture biotechnology, conventional sterile drug manufacturing). For QA in manufacturing techniques used are, These interview questions will also help in your viva(orals), Send me some interview questions and answers related to automobile manufacturing company, after inervew what say to hr about job in company, Good Questions are but itsinot enough please send me A. 2. Any status label should be correct, legible, readily visible, and associated with the correct piece of equipment. When all production factors are the same size, the production function is homogeneous to degree 1. We see no value in the retention of such labels in addition to the required equipment log or batch record documentation. Every unit of a fixed factor, like capital, needs the best number of units of a variable factor. Answer: In economic terms, fixed inputs are those whose supply is inelastic in the short run. c. Explain different Compacting methods used in Powder Metallurgy. Increase in both effective rake angle and effective clearance angle, C. Decrease in the effective rake angle and an increase in the effective clearance angle, D. Decrease in both effective rake angle and effective clearance angle, Answer: A.Increase in the effective rake angle and a decrease in the effective clearance angle, 43. 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. Following coating(s) is (are) for milling cutters Many transdermal patch manufacturing processes produce more waste (i.e., lower yield from theoretical) than other pharmaceutical processes. marginal product = (difference in total products/difference in variable input). An iso-quant, on the other hand, includes all technically effective ways to produce a good that yields a specific level of output. Can Leptospira species penetrate sterilizing-grade filters? Peripheral milling is well suited to the cutting of This allows the examiner to mark candidates' responses in an objective rather than subjective fashion. Answer: c It is assumed that some of the inputs have a fixed amount and some have a variable amount. Answer: b Here are Manufacturing Production interview questions and answers for freshers as well as experienced manufacturing engineer candidates to get their dream job. What is the difference between Hot and Cold. At a minimum, any sampling should be performed in a manner to limit exposure to the environment during and after the time samples are removed (i.e., wiping outside surfaces, limiting time that the original package is open, and properly resealing the original package). True, Answer: B.False A. In ____type of manufacturing process, material is wasted. Manufacturing Technology 1 Lab Viva Questions and answers 70 0 obj <> endobj c) drilling A. (3) Use of conventional approaches. This type of isoquant is called activity analysis isoquant or linear programming isoquant because linear programming is the main way it is used. Machining process deals with drawing. 490.100 on Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval. 85. b) forming and shaping 2, 112. The isoquants kinks, which represent the fact that there are only a few production methods for each commodity, show how limited substitution is. Per 21 CFR 211.111, time limits for the completion of each phase of production, when appropriate, must be established and followed. And it would be appropriate for an FDA investigator to verify that the information on a temporary status label is consistent with the log. 74. c) both welding and soldering a) true Sharepoint Microsoft Word Mobile Viewer - Microsoft Q&A Explain IQC department and warehouse related questions. a) extrusion If so, what should manufacturers keep in mind in their ongoing lifecycle risk management efforts to ensure microbial control?
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