A. by a sleeve, 32. b) forging A. Heavy duty emulsifiable oil, Answer: D.All of the above Built to bore holes, C. Typically bed mills with a long spindle throw, Answer: D.All of the above What are the Agencys recommendations regarding in-process stratified sampling of finished dosage units? Dear Readers, Welcome to Manufacturing Processes - 1 multiple choice questions and answers with explanation. Pocket milling is extensively used in The firm used TSB (nonsterile bulk powder) from a commercial source and prepared the sterile solution by filtering through a 0.2 micron sterilizing filter. A. A. For drilling, the drill is rotated with a downward pressure causing the tool to penetrate into the material. Objective tests can also be an effective teaching tool. Diseconomies of scale are the root cause of diminishing returns to scale. 4. B. Following cutting fluid is used for grinding of Cast iron d) molding and plating. Machining process deals with drawing. Yes, CGMP regulations do require these written procedures. d. With the help of a neat sketch, explain Plastic Injection Molding with its advantages. A. A. true, 36. a) brazing Question 49: What causes a shift in the isocost line? employed in manufacturing must be used in the most cost effective manner. Clarification: Forming and shaping process includes powder metallurgy. While this specific species was the identified contaminant in this case, other Leptospira species also are capable of passing through 0.1 m pore size rated filters (see Faine 1982). C. Rotated by single motor and at same speed. 211.84)(d)(4-5), including applicator material (e.g., cotton pads) and water used as an ingredient in the product. Is the same frequency expected of a process conducted in an isolator? 65. 2001), (b) variability over time of one location, and (c) potential correlation between the powder sample and the unit dosage form. 83. What are some recommended innovative approaches to ensuring adequacy of mixing of powder blends? 13. A. 98. A. In electrochemical grinding, grinding wheel is 72. Normally, media fills should be repeated twice per shift per line per year. An iso-quant, on the other hand, includes all technically effective ways to produce a good that yields a specific level of output. A. We expect that validated and well-controlled processes will achieve fairly consistent waste amounts batch-to-batch. Testing of bulk drug substances produced in the reported cases did not detect theLeptospira species, and no evidence of deleterious effects on in-process product were observed in the known case study. Your IP: Your email address will not be published. 7. Land in economics refers to all the resources that come from the natural world. 53. In cutting Right hand threads, the spindle and lead screw rotates in the 0000000596 00000 n 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. 6. 10. A. true, 110. Perhaps more importantly, correction of answers is entirely objective and comparatively easy. Heavy cuts can be given during machining in Answer ALL questions 1. Cutting speed, 48. A. 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? 21 CFR 211.113(a) specifies that appropriate written procedures be established and followed to prevent growth of objectionable microorganisms in drug products not required to be sterile. c) machining Because of this, output goes up by the same amount as the number of factors of production. What were the Agencys major concerns with this guidance? Shaping machine, Answer: C.Slotting machine Slotting machines are used to cut internal gear teeth for 69. c) The rope acts a limit to new work coming int. Have you always wanted a career in manufacturing? However, in economics, the term labor has a broader meaning. 0 Which of the following attachments can be used on Centre lathe? 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 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. Deep helical grooves running up the cutter, Answer: A.Deep helical grooves running up the cutter Shaping machine, Answer: D.None of these The following part of Lathe serves as housing for the driving pulleys and back gears List the advantages of Forging. and approval or rejection of components, drug product containers, and closures ( 211.80). 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). In how many groups, various metal working processes can be classified? The offer the user the usual options to print. An investigation was launched to trace the source of contamination. Only one answer is strictly correct. At one end, Answer: C.Both (A) and (B) It is assumed that some of the inputs have a fixed amount and some have a variable amount. Planers, Shapers and Slotters FDA is aware of a reportof Leptospira licerasiae contamination in cell cultures (see Chen, Bergenvin, et al. Forming and shaping type process include the process like drawing. 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. 59. 250+ TOP MCQs on Manufacturing Process and Answers Quiz 490.100 on Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval. Additive process: C. Formative process: D. All of above: Answer A. Subtractive process In _____, the cutting action occurs primarily at the end corners of the milling cutter. The sampling and analysis needs to ensure that no differences exist between locations in a blend that could adversely affect finished product quality. 5) Explain what is Six Sigma? The manufacturer is expected to have a sound rationale for its choices in this regard. The bacteria measure 1m in diameter and 10-20 m in length. (Firm's autoclave is too small to permit processing of TSB for media fills, so this was not a viable option.) A. When all production factors are the same size, the production function is homogeneous to degree 1. Even though a drug product is not sterile, a firm must follow written procedures that proactively prevent introduction and proliferation of objectionable microorganisms. 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. marginal product = (difference in total products/difference in variable input). A. Lead screw, 15. Both the input and the output are perfectly divisible. In the bed mill, the table moves ____ to the spindles axis A. Threading, D. Increasing the size of the existing hole for a certain length, Answer: C.Spline cutting As a result, substitution is only possible at the kinks. (4) A comparability protocol can be submitted to the Agency outlining PAT research, validation and implementation strategies, and time lines. will consistently produce a quality product ( 211.100). Wrist motion of y involves. Sorry, preview is currently unavailable. Nice & helpful information, b. A. a) adhesive bonding Which of the following operation, we cant perform on drilling machine? Answer: b 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. It is considered acceptable practice to display temporary equipment status information on dry-erase boards or chalkboards. 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. Question 05: What are the features of the land? D. Arc melting . In economics, labor refers to both physical and mental labor. Clarification: Brazing is the one type of permanent joining process and mechanical joining is the one type of temporary joining process because we can remove the joint with the help of equipments like some type of bolts and so on. The CGMP regulations provide the minimum legal requirements for conducting reliable operations (see 21 CFR part 211). Which of the following is not the type of joining process? Grinding is commonly used on 0000003582 00000 n It is assumed that technology will stay the same. Examples include: a. 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 firm had multiple media fill failures. A. hTr@}0Tms`a4vAgP &oL{}`ZM8PWJHJI/GIA$t1gBJbE!o x~[ A. A. For example, although the CPG does not specifically mention concurrent validation for an API in short supply, the Agency would consider the use of concurrent validation when it is necessary to address a true short-supply situation, and if the concurrent validation study conforms to the conditions identified in the CPG (see paragraph 4, a-c). Honing, Answer: D.All of the above 1. Worm, Answer: D.All of the above The isocost line is also called the outlay line or the line of equal costs. b) brazing 1.What is a lathe? BOM stands for Bill Of Materials; it is a list of item or parts that makeup a product assembly. A machining process used for increasing the size of the existing hole, B. Thin or fragile jobs can be conveniently machined because of lower cutting forces, C. Surfaces with obstruction can also be machined, D. Removal of the whole material in one stroke, Answer: D.Removal of the whole material in one stroke However, a minimum number of conformance (a.k.a. What could be the source of contamination? 15. Explain Roll Forging. Do pharmaceutical manufacturers need to have written procedures for preventing growth of objectionable microorganisms in drug products not required to be sterile? It joints the metal by melting and flowing a filler metal into the joint. Production factors are divided into two categories: Question 12: What are fixed factors or inputs? GMP Questions and Answers / October 2010 Page 3 of 24 Q.6 Does the concept of self-contained facilities apply equally to research and development laboratories (susceptible to contain highly sensitizing, highly potent or potentially pathogenic material in the analytical scale) that may be in the same building as the manufacturing facilities, or . What do you know about our business? 0000004287 00000 n A. Question 35: What are the factors behind the law of returns? 2003). validation) batches necessary to validate the manufacturing processes is not specified. 0000002875 00000 n 1. 103. BASIC MANUFACTURING PROCESSES Basic Manufacturing Processes (NME-101/201). c) twisting of the object about the arm axis. 6. A. d) none of the mentioned. Same, vertical, Answer: A.Same, vertical Explain different Extrusion processes. b. What is mean by Directional solidification? What could be the source of contamination? Answer: The marginal product is the amount by which the total product goes up when one more unit of a variable factor is used. Answer: a Clarification: It is a metal joining process. A. This is one way we can change how the factor is put together and see how it affects the output. Face milling, 49. A. 5. A. It implies that a commodity can only be produced using a single method. A. Cylindrical surfaces, C. The surfaces which are neither cylindrical nor tapered, Answer: C.The surfaces which are neither cylindrical nor tapered, 29. Answer: b What are your greatest strengths and weaknesses as a production worker? Answer. The term production has a specific meaning in economics. Which of the following processes are included in finishing? Following coating(s) is (are) for milling cutters Synthetic oil is used as cutting fluid in grinding for Question 18: What are the assumptions of the production function? The work holding device in surface grinding is known as 450.100). Impact in-process production (e.g., production yields, impurity levels, process performance) Go undetected due to the limitations of current compendial bioburden tests in detecting this microbial . Production Management MCQ [Free PDF] - Objective Question Answer for 104. A. Answer: d Consider all possible sources of microbial contamination, including the following: Components or products stored in open bins can be at risk for contamination by spore-forming microbes, such as. 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. 1000 Manufacturing Processes MCQ (Multiple Choice Questions The .gov means its official.Federal government websites often end in .gov or .mil. Six sigma is a data-driven methodology and approach for eliminating defects in any process from manufacturing to transactional and from product to service. What is the purpose of Chills and Chaplets? Answer: An isoquant is a place where all the combinations of production factors that lead to a certain level of output are found. If you read these 50 important theory of production questions and answers on a regular basis, you will gain a better understanding of the chapter. Kanban is scheduling system which advises manufacturers about how much to produce, what to produce and when to produce. The meaning of the term objectionable needs to be evaluated on a case-by-case basis by each drug manufacturer. In this case, the variable factors marginal product must be going up. Therefore, because the procedure and acceptance criteria prescribed in section VII provided only limited statistical assurance that batches of drug products met appropriate specifications and statistical quality control criteria, FDA no longer supports their use for batch release. The goal is to remove any unnecessary materials, tools, equipment, or inventory that do not contribute to the production process. To cut a screw of 3mm pitch on Lathe machine having same speeds of spindle and lead screw, the tool should move, parallel to the axis of the work, a distance of ____ for every revolution of the spindle. 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. 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. A. by chucks, 39. 68 questions with answers in LEAN MANUFACTURING | Science topic GMP is a good manufacturing practice and is recognized worldwide for the control and management of manufacturing and quality control testing of foods, medical devices and pharmaceutical products. The drilling machine was primarily designed to originate a _____ 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. B. 63. True, Answer: B.False Is this okay? In this case, as a business increases its output, the cost per unit starts going down. A. A desired speed of _____ can be obtained by selecting the suitable change gears havingproper number of teeth. Answer: The following are the key features of labor in economics: Answer: Capital is another factor in production. 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. before a batch disposition decision is made. document.getElementById("ak_js_1").setAttribute("value",(new Date()).getTime()); Economics 2021 JAMB Past Questions and Answers | Questions 21 - 30, 40 Important Types of Business Communication Questions and Answers [With PDF], 60 Important Capital Budgeting Questions and Answers [With PDF], 30 Important Introduction to Business Communication Questions and Answers [With PDF], 30 Important Theory of Cost Questions and Answers [With PDF], 50 Important Theory of Production Questions and Answers [With PDF]. Answer: Diminishing returns to a factor happen when the increase in marginal product from each additional unit of a variable factor starts to go down but stays positive. The effect of setting a boring tool above center height leads to 67. Good Manufacturing Practices Question 1: Consider the following statements: A. In this system, inventory is re-filled only when visual cues like an empty bin or cart is seen. The following is used to support too flexible job very close to the cutting edge. Which of the following is the type of permanent joining process? Some of the companies that provide the manufacturing software solution are SAP, Oracle ERP system, etc. 185.142.46.18 M|I(ja$RWY%:M. d) none of the mentioned. On drilling machine, which process is known as reaming? A firm has multiple media fill failures. The factors affect the manufacturing process are. Please refer to ASTM E2709 and ASTM E2810 for further guidance on establishing acceptance criteria for a stratified sampling plan. In addition, the book emphasises problem areas and attempts to help students avoid common mistakes in financial accounting. a) true 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 Per 21 CFR 211.111, time limits for the completion of each phase of production, when appropriate, must be established and followed. 20. Two types of tests are generally used. Answer: Following are the points of distinction: (a) An integrated steel plant is larger than mini steel plant. Powder metallurgy is a process in which material or shapes are made from or by using metal powders. 41 Production Supervisor Interview Questions (With Example Answers 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 . However, due to the unique aspects of producing sterile drug products by aseptic processing (e.g., microbiological issues), an aseptic processing manufacturer should not rely solely on 14644-1 and 14644-2 when qualifying its facility. A. A. Chuck, Answer: A.Chuck For example, some product considerations for manufacturers include, but are not limited to: 14. 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. Explain different defects in Casting with neat sketches. Sawing and Broaching Machines 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. Since we were encouraged to submit a proposal. b) casting Explain different types of Rolling Mills. Investigation did not show any obvious causes. Controlled the entire steel making process from mining to . 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. 1999). In cylindrical grinder, how many centers hold the workpiece? 1. a) steels. 21. 12. d. What are the common Welding defects? The location of the food industry should be away from environmentally polluted areas. 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. Some products, such as transdermal patches, are made using manufacturing processes with higher in-process material reject rates than for other products and processes. Successful completion of the initial conformance batches would normally be expected before commercial distribution begins, but some possible exceptions are described in the CPG. Explain Rolling of Channels, I and Rail sections. Profile sharpened type, Answer: A.Profile sharpened type Leptospira are obligate aerobes that use oxygen as the electron receptor and long-chain fatty acids as a major source of energy. Academia.edu no longer supports Internet Explorer. 8. Which of the following is the type of temporary joining process? Clarification: Only burnishing is an example of finishing process. 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? It is in the form of chips. 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? PDF Manufacturing Interview Questions - Skillful Once that level has been determined, firms may establish appropriate corresponding analytical test specifications. Quality Control MCQ [Free PDF] - Objective Question Answer for Quality 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). The media fill runs, simulating the filling process during production, were conducted inside an isolator. b) soldering A. Boring, 41. How many types of broaches are there? 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? Examples of these kinds of status labels include mixing lot ###; clean, ready for use as of d/m/y; and not clean. What does objectionable mean anyway? 7. Shailendra soni, Can I get more questions on aero space production line. ), 1982, Guidelines for the Control of Leptospirosis, Geneva: World Health Organization, Ricaldi, JN, DE Fouts, JD Selengut, DM Harkins, KP Patra, et al., 2012, Whole Genome Analysis of, Matthias, MA, JN Ricaldi, M Cespedes, MM Diaz, RL Galloway, et al., 2008, Human Leptospirosis Caused by a New Antigenically Unique, Bharti, AR, JE Nally, JN Ricaldi, MA Matthias, MM Diaz, et al., 2003, Leptospirosis: A Zoonotic Disease of Global Importance, Lancet Infect Dis, 3:757771, Ellinghausen, HC, and WG McCullough, 1965, Nutrition of, Rule Pl, and AD Alexander, 1986, Gellan Gum as a Substitute for Agar in Leptospiral Media, J Clin Microbiol, 23(3):500504, Frank S, and J Kohn, 1973, J Amer Med Technology, JulyAug, Wu, H, M Tawakkul, M White, and M Khan, 2009, Quality-by-Design (QbD): An Integrated Multivariate Approach for the Component Quantification in Powder Blends, International Journal of Pharmaceutics, 372(1-2):3948, El-Hagrasy, A, H Morris, F DAmico, et al., 2001, Near-Infrared Spectroscopy and Imaging for the Monitoring of Powder Blend Homogeneity, Journal of Pharmaceutical Sciences, 90(9):12981307. c. Consideration of special stain techniques or other means to identify the presence of Leptospira (Frank and Kohn 1973). What is the difference between Hot and Cold. During the manufacturing process, whatever the cost is incurred during the process is referred as factory overhead, excluding the cost of materials and direct labours. Top 20 Manufacturing Interview Questions and Answers - Guru99 Question 47: What is the shape of the iso-cost curve? 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. (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). However, for aseptic filling conducted in an isolator over two shifts, it may be justified to perform fewer than four media fill runs per year, while still evaluating the line semiannually to ensure a continued state of aseptic process control. Following is a type of centerless grinding 90+ Advanced Manufacturing Method Solved MCQs with PDF Download - McqMate 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). 2. However, the procedures and acceptance criteria in General Chapter <905> are not a statistical sampling plan and so the results of the procedures should not be extrapolated to larger populations. Evaluate risk of contamination from components, including during component production, storage, or due to the intrinsic risk from source materials. Following are the overheads aproductionmanufacturing engineer has to consider: Supervising a manufacturing process includes attending to the individual phases of the production. 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. A. No. Firms should continue to properly employ basic, standard microbiology laboratory practices to detect contamination. It sometimes also includes the details about how the complaint should be addressed. trailer A. Flute, Answer: A.Flute Jig borer are You can calculate all the below factors to know the costing for the manufacturing work in progress. Plz. a. A milling cutter may have surfaces made of 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.
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