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This analysis can demonstrate that variability attributable to sample location is not significant and that the powder blend is homogenous. A. uFoyYM~]' &]/MV8+dM @DCD+AI* K5"Yfc?*. ZB32,S0me`]0O\@( r"0 _( 82. Incorrect. Most CNC milling machines are List of the Most Frequently Asked Manufacturing Interview Questions: 1) Explain the term BOM? PDF Management Accounting - ACCA Global Why chip breakers are provided on the broach? Labels are merely one way to display temporary status information about a piece of equipment. In broaching, generally the broach remains fixed and the workpiece travels providing cutting velocity. Many transdermal patch manufacturing processes produce more waste (i.e., lower yield from theoretical) than other pharmaceutical processes. Question 42: What is the cause of constant returns to scale? BASIC MANUFACTURING PROCESSES Basic Manufacturing Processes (NME-101/201). The following is used in Magnetic chucks A. Electromagnet, 18. 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. Top 20 Manufacturing Interview Questions and Answers - Guru99 Capital is a product that is used to fuel further production. a) true Answer: a Manufacturing Industries Class 10 MCQ PDF Download. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Download link is provided below to ensure for the Students to download the Regulation 2017 Anna University ME8451 Manufacturing Technology - II Lecture Notes, Syllabus, Part-A 2 marks with answers & Part-B 16 marks Questions with answers, Question Bank with answers, All the materials are listed below for the students to make use of it and score . For example, the effective sample size of powder examined by PAT probes has to be estimated such that the scale of scrutiny of the PAT powder blending monitoring can be justified (Wu, Tawakkul, et al. Please understand that 14644-1 and 14644-2 have superseded Federal Standard 209E, Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones (Federal Standard 209E). A. Section 211.165(f) mandates that drug products failing to meet established standards or specifications be rejected. The offer the user the usual options to print. Do the CGMP regulations require a firm to retain the equipment status identification labels with the batch record or other file? 10) List out the factors that can affect the manufacturing process? will consistently produce a quality product ( 211.100). Thanks you so much for this, Your email address will not be published. 62. Clarification: In machining process, some raw material is wasted in or in order to perform different operations like drilling, turning etc. Shaping machine only, Answer: D.All of the above It is considered acceptable practice to display temporary equipment status information on dry-erase boards or chalkboards. Question 09: What are the features of capital? Question 05: What are the features of the land? Answer: There are two types of production functions: Question 16: What is the short-run production function? 89. 35 Production Worker Interview Questions (With Answers) Evaluate risk of contamination from components, including during component production, storage, or due to the intrinsic risk from source materials. GATE Production and Industrial Engineering Question Paper PDF are available for download here. b. Planers, Shapers and Slotters A. turning, 106. This website is using a security service to protect itself from online attacks. What is the difference between Hot and Cold. Answer: The ratio of input prices is shown by the slope of the iso-cost line. It is a change request that mentions the issues with the process or material from a supplier and ask for a resolution. Question 27: What is the marginal product? The exhaustibility of natural resources is another factor causing diminishing returns to scale. Some of the companies that provide the manufacturing software solution are SAP, Oracle ERP system, etc. Answer: The kinked isoquant curve indicates that the production factors are only partially interchangeable. A. Is the same frequency expected of a process conducted in an isolator? 8 answers. Forming and shaping type process include the process like drawing. 2. Which of the following device is not used for holding the work in a drilling machine? A. 104. Answer: b Question 40: What are the reasons for increasing returns to scale? The conditions outlined in the CPG include expanded testing for each batch intended to address a short-supply situation. A. true, 35. Questions and Answers on Current Good Manufacturing Practice A. Cylindrical surface, 114. Answer: B.Swivel Internal keyway in gears can be cut in c) Mixture of copper oxide and zinc oxide. Lean Production and Just in Time Discuss how inventory disguises possible problems in the production system. Manufacturers should assess their operations, be aware of potential risks, and apply appropriate risk management based on an understanding of possible or emerging contamination risks (seesection 18.3 in ICH guidance for industry Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients). MANUFACTURING INDUSTRIES SHORT ANSWER TYPE QUESTIONS [3 MARKS] 1. For now, this firm has decided to filter prepared TSB, for use in media fills, through a 0.1 micron filter (note: we do not expect or require firms to routinely use 0.1 micron filters for media preparation). Shailendra soni, Can I get more questions on aero space production line. 18. It can be obtained by dividing the total output by the total number of units of factor employed. Clarification: Only rolling, forging and sheet forming are included in forming and shaping process. Answer: The following are the key features of labor in economics: Answer: Capital is another factor in production. 98. 5. What is the purpose of Chills and Chaplets? The isoquants kinks, which represent the fact that there are only a few production methods for each commodity, show how limited substitution is. 1.1 Introduction Scallan-01.qxd 2/24/03 2:38 PM Page 1 Average product = (Total product/Inputs of variable factors). 4. 9) What is the challenge in manufacturing products? C. Rotated by single motor and at same speed. Manufacturing Process Model Exam Question Paper | PDF - Scribd FDA's process validation guidance now recommends a product lifecycle approach. This means that the manufacturing of the products must be planned to make best use of these resources, which is the very essence of process planning. Aerospace industry, Answer: C.Both (A) and (B) 7. Although 14644-1 and 14644-2 are not FDA regulations or FDA guidance, the Agency believesthat they are useful in facilitating the international harmonization of industrial air classification for nonviable particle cleanliness in multiple industries (e.g., computer, aerospace, pharmaceutical). If a manufacturer proposes to use a thief sampling method, the reliability of the method should be evaluated as part of analytical methods development. 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. Question 14: What is the production function? when the factors spending remains constant while their prices change. 0000004287 00000 n xb```f``Zj |@1*>D{V}~. ]~yPy4yRFbYy=gNq-)d,2x Drug manufacturers should not rely on antimicrobial preservatives to reduce initial out-of-specification plate counts to within-specification levels and then market the product. When a manufacturer decides to implement PAT or other process-monitoring and control techniques for powder blend homogeneity assessment, its decision should be supported with appropriate data and rationale using a science- and risk-based approach. Question 07: What are the features of labor? Which of the following attachments can be used on Centre lathe? No. 1. The speed at which the piece advances through the cutter is called Normally, media fills should be repeated twice per shift per line per year. The following is the equation: Question 15: What are the types of production functions? A. Finally, drug manufacturers should review their manufacturing process to determine procedures or equipment that might introduce contaminating microorganisms into the process or product. (2) Use of molecular or nonconventional microbial monitoring methods at appropriate intervals to detect microbial flora that may exist in processing steps or in the immediate environment, but are not readily detected by current routine methods. Candidates will be able to download GATE PI 2023 Question Paper after the completion of the exam on Feburary 11, 2023 (Afternoon Session). Answer: A production method is a set of the factors of production (or factor inputs) needed to produce a single unit of output. Answer: c Between- and within-location variability in the powder blend is a critical component of finished product quality and therefore should be evaluated. Batch production is a manufacturing technique, where components or goods are produced in groups and not in a continuous stream. 2. Clarification: This is false. A. true, 36. PDF BASIC MANUFACTURING PROCESSES - iMechanica Question 18: What are the assumptions of the production function? Length of the stroke can be varied in 67. Computer Integrated Manufacturing Questions and Answers - Scribd In cutting Right hand threads, the spindle and lead screw rotates in the Answer: Some of the assumptions that the analysis of the production function is based on are: Question 19: What is the method of production? 41 Production Supervisor Interview Questions (With Example Answers 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. In the bed mill, the table moves ____ to the spindles axis xref A. How can I implement PAT (process analytical technology)? Please include what you were doing when this page came up and the Cloudflare Ray ID found at the bottom of this page. 5. Shaping machine, Answer: D.All of these 16. You can email the site owner to let them know you were blocked. d) joining. 84 0 obj <>stream A milling cutter may have surfaces made of Hence , at the begining of industry 4.0 implementation . Innovative approaches to consider include, but are not limited to: (a) PAT real-time monitoring and feed-forward controlling of the powder blending process (see the guidance for industry PATA Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance) and (b) use of statistical process control tools to monitor the powder blending process and to maintain a state of control. 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. Answer: An isoquant is a place where all the combinations of production factors that lead to a certain level of output are found. In March 2004, FDA revised the Compliance Policy Guide (CPG) Sec. A. 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. The location of the food industry should be away from environmentally polluted areas. 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)). Even though a drug product is not sterile, a firm must follow written procedures that proactively prevent introduction and proliferation of objectionable microorganisms. Expanded testing conducted according to an established validation protocol could provide added assurance that the batch meets all established and appropriate criteria before the API is used in the finished drug product. Mechanical properties, Answer: D.All of the above On the other hand, the theory of production explains how a company makes production decisions that minimize costs and maximize profits, as well as how the companys production costs change with how much it makes. marginal product = (difference in total products/difference in variable input). when the price of the factors remains constant but the companys overall spending changes. The 2004 guidance for industry on Sterile Drug Products Produced by Aseptic Processing states that "[A]ctivities and interventions representative of each shift, and shift changeover, should be incorporated into the design of the semi-annual qualification program." 96. The supply of capital can be increased or decreased. At the first 1 g of HIPS polystyrene thermoplastic polymer was mixed with 10 cc of toluene solution for 1 hour and a half using a magnetic stirrer. Two types of tests are generally used. MES stands for a system that manages and controls the production on the factory floor with the motive of reducing the total time required to produce an order. May 30, 2019. (adsbygoogle = window.adsbygoogle || []).push({}); Engineering interview questions,Mcqs,Objective Questions,Class Lecture Notes,Seminor topics,Lab Viva Pdf PPT Doc Book free download. 2009). Same, vertical, Answer: A.Same, vertical Cutting speed, 48. Only parallel, Answer: B.Only perpendicular A turret mill has a ____ spindle and the table is moved ____ to the spindle axis to accomplishcutting. Sample Practice Questions, Answers, and Explanations - Wiley Online Library Additionally, the second paragraph of USP General Chapter <51> Antimicrobial Effectiveness Testing reads: Antimicrobial preservatives should not be used as a substitute for good manufacturing practices, solely to reduce the viable microbial population of a nonsterile product, or control the presterilization bioburden of a multidose formulation during manufacturing. Write short notes on Plastic Blow Molding. Outside diameter grinding, Answer: D.All of the above DoesCGMP require three successful process validation batches before a new active pharmaceutical ingredient (API) or a finished drug product is released for distribution? E. None of the above . Answer: One important thing that makes returns on a variable factor go up is that a fixed factor cant be split up. Questions and Answers(R4) . 490.100 on Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval. B. Rotated by separate motors and at same speed. What is mean by Directional solidification? A. 70 0 obj <> endobj The 50 most important "theory of production" questions and answers are as follows: Question 01: What is production? Answer: d Some materials, especially from natural sources, may have high or objectionable intrinsic bioburden. 102. [PDF] ME8451 Manufacturing Technology - LearnEngineering.in Interview Questions Below are occupation and industry specific skills-based interview questions and technical demonstrations to use to evaluation candidates. Therefore, it was not a contaminant from the process, but from the media source. What are your greatest strengths and weaknesses as a production worker? Because there are potentially many different root causes of product contamination by microorganisms, it is imperative that manufacturers perform a manufacturing risk assessment to understand manufacturing failure modes and implement prevention measures. Shaping machine, Answer: D.None of these What specific CGMP regulations might be useful to manufacturers of topical antiseptic drug products? These things are then used to make other things. In this case, the variable factors marginal product must be going up. Wrought <.2% Steel .2-2.3% Cast Iron 2.3-4.2% . b) false. In other words, it shows how the total output keeps going up as more units of the variable factor are added. A. Grinding dog. What does. 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. For correct setting for turning operation in a lathe machine, the tool nose should touch the workpiece _____ horizontal line which is parallel to and at the same level as the axis of correctly centred workpiece. 0000001874 00000 n Answer: c Please refer to ASTM E2709 and ASTM E2810 for further guidance on establishing acceptance criteria for a stratified sampling plan. 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. Large number of cutting tools can be simultaneously used in. Six sigma is a data-driven methodology and approach for eliminating defects in any process from manufacturing to transactional and from product to service. 63. Some inputs, like machinery, management skills, and so on, can only be used for a certain size of production. The adjoining metal has higher melting point compare to filler metal. Also, manufacturing supervisor should have a close eye on the inventory that going to be used. ", FDA Guidance for Industry, 2004,Sterile Drug Products Produced by Aseptic Processing, EU Annex 1, 2003, Manufacture of Sterile Medicinal Products, Penetrate sterilizing-grade membrane filters, Be present in the manufacturing site environment, Impact in-process production (e.g., production yields, impuritylevels, process performance), Go undetected due to the limitations of current compendial bioburden tests in detecting this microbial genus, Chen, J, J Bergenvin, R Kiss, G Walker, T Battistoni, P Lufburrow, H Lam, and A Vinther, 2012, Case Study: A Novel Bacterial Contamination in Cell Culture Production, Faine, S (ed. Heavy cuts can be given during machining in 6. Casting includes grinding process. Free PDF Download: Manufacturing Production Interview Questions and Answers. For such closed systems,1 if the design of the processing equipment is robust and the extent of manual manipulation in the manufacturing process is minimized, a firm can consider this information in determining its media fill validation approach. 0000002376 00000 n The work-table can rotate in View Answer. Question 30: What are the assumptions of the law of variable proportions? Examples include: a. Establish and follow in-process bioburden testing. Shaping machine, Answer: D.None of these 91. Save my name, email, and website in this browser for the next time I comment. By reading this post, you can quickly prepare for economics courses and other competitive exams such as Vivas, job interviews, and school and college exams. 84. There are three different kinds of returns to scale, which are: Question 39: What are the increasing returns to scale? A. The T-slots in the table of planning machines are cut in. The number of PAT probes and their locations also have to be justified. First, they allow the examiner to ask questions on every topic on the syllabus and thus test the candidates range of knowledge. When all production factors are the same size, the production function is homogeneous to degree 1. In this case, as a business increases its output, the cost per unit starts going down. <<2BFF83D679D3CA49AB51E34DB865E38F>]>>

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