Answer: The iso-cost line will shift under two conditions: Question 50: What is the least cost combination? 92. 5. c) both brazing and mechanical joining Such expanded testing should be used to modify the strategy (e.g., timing, frequency, types of tests) of detection and control in the event of newly identified risk posed by the viable, but not easily cultured, microorganism. Answer: The total product is the sum of all the goods and services that a company makes with a certain number of inputs. A. true, 33. Which of the following is the type of temporary joining process? See correct answer (a). Do pharmaceutical manufacturers need to have written procedures for preventing growth of objectionable microorganisms in drug products not required to be sterile? A. How many types of broaches are there? 60. 56. You can download the paper by clicking the button above. 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. At one end, Answer: C.Both (A) and (B) A machining process used for grinding hardened steel, C. A machining process used for making intricate holes accurately, D. A machining process for removal of a layer of material of desired width and depth, Answer: D.A machining process for removal of a layer of material of desired width and depth, 76. A firm's justification for the frequency of media fills in relation to shifts should be risk based, depending on the type of operations and the media fill study design. Large number of cutting tools can be simultaneously used in. 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. 11. including water systems, operates consistently and is clean, sanitary, andsuitable for its intended use ( 211.63, 211.65, 211.67, and 211.68). The labels serve a valuable, temporary purpose of positively identifying the current status of equipment and the material under process. BASIC MANUFACTURING PROCESSES Basic Manufacturing Processes (NME-101/201). Answer ALL questions 1. A. Countershaft, ---- >> Below are the Related Posts of Above Questions :::------>>[MOST IMPORTANT]<, Your email address will not be published. In November 2001, the U.S. General Services Administration canceled Federal Standard 209E. A. true, 110. Large numbers of scripts can be objectively tested in a short space of time. What is broaching? It is in the form of chips. 8. 0000001874 00000 n d) none of the mentioned. Profile sharpened type, Answer: A.Profile sharpened type Line AB goes through all the different combinations of labor and capital that a company can buy for a certain amount of money at a certain price for each factor of production. What are the Agencys recommendations regarding in-process stratified sampling of finished dosage units? Mycoplasma contain only a cell membrane and have no cell wall. What is mean by Directional solidification? View Answer. Assuming each major piece of equipment has a unique cleaning and use log that is adequately retained, is it acceptable to discard these quick reference equipment labels? (Firm's autoclave is too small to permit processing of TSB for media fills, so this was not a viable option.) b) soldering Answer: Constant returns to scale happen when the quantity of the factors of production is increased while keeping the ratio of the factors constant. Question 36: What are the limitations of the law of variable proportions? The job reciprocates in Acholeplasma laidlawii belongs to an order of Mycoplasma. How can manufacturers assess and address the risk of microbiological contamination of topical antiseptics? Clarification: Only burnishing is an example of finishing process. What are the Agencys recommendations regarding in-process stratified sampling of finished dosage units? Such procedures shall include validation of all aseptic and any sterilization process. Answer: d 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. Brazing and soldering are also the type of manufacturing process. A. drilling and milling, 108. Hello, Does anyone have a solution for the problem below: We have a library with documents, in the public sharepoint ON-PREMIESE 2016 portal. What are your greatest strengths and weaknesses as a production worker? FDA recognizes that validating a manufacturing process, or a change to a process, cannot be reduced to so simplistic a formula as the completion of three successful full-scale batches. 6. Answer: a A. 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. 58. Which of the following attachments can be used on Centre lathe? Establish and follow in-process bioburden testing. 7. Answer: b This is to preserve the fitness for use of the remaining containers or closures as well as to ensure sample integrity, if they are to be examined for microbial contamination. Validated analytical methods are needed for testing every batch, including validation batches. A. 65. c) none of the mentioned a) machining B. Rotated by separate motors and at same speed. Which of the following broaches are re-sharpened by grinding at rake faces? Click to reveal 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. Which of the following is the type of permanent joining process? In other words, there is at least one factor that cannot be changed in the short run. These things are then used to make other things. a) extrusion The T-slots in the table of planning machines are cut in. Assuming each major piece of equipment has a unique cleaning and use log that is adequately retained, is it acceptable to discard these. A. Successful completion of the initial conformance batches would normally be expected before commercial distribution begins, but some possible exceptions are described in the CPG. Why push type broaches are made shorter in length? document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); Technical Interview Questions and Answers (2023), How to Write a Resume & CV with Format & Template Examples, Top 45 Logistics Interview Questions and Answers (2023). Question 27: What is the marginal product? MCQs have a number of advantages over traditional examination formats. b) aluminium alloys. In manufacturing unit, software that can be useful are Manufacturing ERP and Material Management. . Is it generally acceptable from a CGMP perspective for a manufacturer of sterile drug products produced by aseptic processing to rely solely on ISO 14644-1 and ISO 14644-2 when qualifying its facility? The variable factors units are all homogeneous. A. 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. Generally, we believe that sampling in a typical drug manufacturing facility warehouse would not represent a risk to the container or closure or affect the integrity of the sample results. 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. In addition, the EU Annex 1, Manufacture of Sterile Medicinal Products, states that "Normally, process simulation tests should be repeated twice a year per shift and process.". Steady rest, 21. 3. Machining process deals with drawing. For drilling, the drill is rotated with a downward pressure causing the tool to penetrate into the material. It is considered acceptable practice to display temporary equipment status information on dry-erase boards or chalkboards. Lead screw, 15. A. Many more Questions related to production Engineer, Please send me production and IPQC questions and answers. Flat surface can be produced in No. 70 0 obj <> endobj This is most pronounced for processes involving lamination of rolls of various component layers. Example: "In my current position, I find time management to be a key factor in meeting . A. The initial test results exhibiting out-of specification levels of microbes are not disqualified even if subsequent test results are within specifications. Water quality can pose a significant risk, as most antiseptics include water as a key ingredient. 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. They conducted their media fills using TSB (tryptic soy broth) prepared by filtration through a 0.2 micron sterilizing filter. Why is FDA concerned about proper sampling of powder blends? The Agency would also expect the manufacturer to use a validation protocol that includes a review and final report after multiple batches are completed, even though the earlier batches may have been distributed or used in the finished drug product. Forming and shaping type process include the process like drawing. Question 24: What is input-output isoquant? Capital is a product that is used to fuel further production. A. by a sleeve, 32. If a manufacturer proposes to use a thief sampling method, the reliability of the method should be evaluated as part of analytical methods development. Whether this apparently rare contamination risk may be more widespread is unknown, and we are sharing this information so that manufacturers can consider whether this hazard may be relevant to their operations. Question 41: What are the constant returns to scale? 0000004287 00000 n Answer: A short run is a period of time during which the quantities of one or more production factors cannot be changed. For interview questions, you may use them as written, but we suggest making them as specific as possible to your position. Is it generally acceptable from a CGMP perspective for a manufacturer of sterile drug products produced by aseptic processing to rely solely on ISO 14644-1 and ISO 14644-2 when qualifying its facility? 5) Explain what is Six Sigma? Performance & security by Cloudflare. Validation and control over microbial content of purified water systems used in certain topical products are also examples of such procedures (see FDA guidance, referenced below). c) The rope acts a limit to new work coming int. What is the acceptable media fill frequency in relation to the number of shifts? c. Explain Ultrasonic welding process and Friction welding process with neat sketches. Shaping machine, Answer: C.Slotting machine b) casting The location of the food industry should be away from environmentally polluted areas. Question 07: What are the features of labor? Machine Tools Multiple Choice Questions on Manufacturing Process. Which type of job motion is there in drilling operation? <<2BFF83D679D3CA49AB51E34DB865E38F>]>> Is the same frequency expected of a process conducted in an isolator? 9) What is the challenge in manufacturing products? c) soldering Leptospira are obligate aerobes that use oxygen as the electron receptor and long-chain fatty acids as a major source of energy. What specific CGMP regulations might be useful to manufacturers of topical antiseptic drug products? Here are 1000 Manufacturing Processes MCQ (Chapterwise). Write about the kinds of polarity in Arc Welding. Grinding Machines and Abrasives ", 21 CFR 211.113(b), whichstates that "Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed. Centers for Disease Control and Prevention, 2011, Recalls, Market Withdrawals and Safety Alerts, Product-Specific Guidances for Generic Drug Development, Guidance, Compliance, & Regulatory Information, Questions and Answers on Current Good Manufacturing Practice Regulations | Production and Process Controls, Do the CGMP regulations require a firm to retain the equipment status identification labels with the batch record or other file? In end mill cutter, chips are pulled up the A. It is often used in a transaction where a customer returns goods to the manufacturer for replacement or repair purpose. (2) As another quality system implementation option, FDA invites manufacturers to request a preoperational review of their PAT manufacturing facility and process(see ORA Field Management Directive No.135). Question 14: What is the production function? A. A. reaming, 30. This type of isoquant is called activity analysis isoquant or linear programming isoquant because linear programming is the main way it is used. Face milling, 49. Firms may then apply the analytical tests for preservative content at batch release and throughout the shelf life of lots on stability. Following coating(s) is (are) for milling cutters A. Normally, media fills should be repeated twice per shift per line per year. Write short notes on Explosive Welding process. Why is FDA concerned about proper sampling of powder blends? What is the difference between Hot and Cold. (3) A supplement (Changes Being Effected (CBE), CBE-30, or Prior Approval Supplement (PAS)) can be submitted to the Agency prior to implementation, and, if necessary, an inspection can be performed by a PAT-certified investigator before implementation. A. Boring, 41. FDAs major concern was that sections V and VII of the withdrawn draft guidance no longer represented the Agencys current thinking, as explained below. Property taxes on manufacturing facilities, Cost of ending work in process for the accounting period. To browse Academia.edu and the wider internet faster and more securely, please take a few seconds toupgrade your browser. 2003). 72. validation) batches necessary to validate the manufacturing processes is not specified. A. 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). The goal is to remove any unnecessary materials, tools, equipment, or inventory that do not contribute to the production process. 2. Which of the following method is not used for holding tool? establish and follow written procedures designed to. Such a process should ensure greater understanding of the topic under discussion. This book is suitable for students taking introductory financial accounting examinations of the professional accountancy bodies, third level accounting students or other students studying introductory financial accounting courses. Section V (Exhibit/Validation Batch Powder Mix Homogeneity) recommended that at least 3 replicate samples be taken from at least 10 locations in the powder blender, but that only 1 of the 3 replicates be evaluated to assess powder blend uniformity. 13) Explain how to supervise in a manufacturing unit? Diseconomies of scale are the root cause of diminishing returns to scale. 69. In electrochemical grinding, the pieces from the workpiece For a nonsterile compendial drug product that includes an antimicrobial preservative in its formulation, may I release and market lots of this drug product with initial out-of-specification total aerobic plate counts if these lots test within specification 2 weeks later?