Do pharmaceutical manufacturers need to have written procedures for preventing growth of objectionable microorganisms in drug products not required to be sterile? Following collaborative review of the general strategy outlined in the comparability protocol, the regulatory pathway can include implementation under the facility's own quality system, a preoperational review, CGMP inspections (either before or after PAT implementation), a combination of these, or another flexible approach. 9. Top 20 Manufacturing Interview Questions and Answers - Guru99 Answer: The term least cost combination of factors refers to a firm that, on the one hand, produces the greatest amount of output from a given level of inputs and, on the other hand, produces a given level of output at the lowest cost when the factors are combined in the best way possible. The location of the food industry should be away from environmentally polluted areas. Casting doesnt includes grinding process. A. Enlargement of existing hole, B. Hole made by removal of metal along the hole circumference, C. Smoothly finishing and accurately sizing a drilled hole, Answer: C.Smoothly finishing and accurately sizing a drilled hole, 46. Answer: Following are the points of distinction: (a) An integrated steel plant is larger than mini steel plant. In ____type of manufacturing process, material is wasted. PDF 1 Introduction to manufacturing - Elsevier 84. What specific CGMP regulations might be useful to manufacturers of topical antiseptic drug products? a) welding A. counter-boring, Answer: B.counter-sinking Face milling, 49. This set of Manufacturing Engineering Multiple Choice Questions & Answers (MCQs) focuses on. Rest all( mentioned ) are included in finishing process. Heavy cuts can be given during machining in 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. 83. c. Explain Ultrasonic welding process and Friction welding process with neat sketches. 95. Academia.edu no longer supports Internet Explorer. The Agency encourages firms to adopt more innovative approaches to ensuring adequacy of mixing (see, e.g., the guidance for industry PATA Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance). Statistical tools are available to ascertain both the number of replicates and the number of sampling locations across the blender that should be analyzed to conduct a valid analysis. A. A. Cylindrical surface, 114. On drilling machine, which process is known as reaming? In such cases, FDA still expects the manufacturer to reject the drug product based on the initial results. The guidance reflects the current working procedure . Interview Questions Below are occupation and industry specific skills-based interview questions and technical demonstrations to use to evaluation candidates. In todays world, it doesnt make sense to think that prices for inputs and production methods will stay the same. The drilling machine is the second most important machine tool in a workshop. Machining process includes grinding process. However, a minimum number of conformance (a.k.a. Answer: All of the components that go into making a product is referred to as factors of production. The following are important production factors: Answer: The first and most important component of production is the land. Shaping machine, Answer: C.Slotting machine Grinding Machines and Abrasives QMS stands for Quality Management System; it documents all necessary information about companys design and operational controls, including issue reporting, monitoring, continuous improvement and training, to make sure that company delivers continuous product. Only one answer is strictly correct. 62. It depends on the cause and consistency of the reject rate. Answer: following are the key features of capital: Answer: The organization is the fourth and final component of production. Document and implement any corrective actions deriving from the evaluation ( 211.192). You can email the site owner to let them know you were blocked. c) coating and milling Answer: The marginal product is the amount by which the total product goes up when one more unit of a variable factor is used. In cylindrical grinder, how many centers hold the workpiece? In how many groups, various metal working processes can be classified? Is the same frequency expected of a process conducted in an isolator? limited ability to substitute one factor for another because labor and capital are insufficient replacements. DoesCGMP require three successful process validation batches before a new active pharmaceutical ingredient (API) or a finished drug product is released for distribution? A. turning, 106. A. b. Which manufacturing process includes the powder metallurgy? Question 13: What are the variable factors? 11. The Lathe carriage serves the following purpose of the tool 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. The CGMP regulations require that the management of a manufacturing facility maintains a well-functioning quality system, which includes an effective quality unit vested with the responsibilities and authorities required under CGMP ( 211.22). Answer: b The following is used for holding bored parts for machining their outside surfaces onLathe. Stainless steel is very difficult to grind due to its Diseconomies of scale are the root cause of diminishing returns to scale. Sample Practice Questions, Answers, and Explanations - Wiley Online Library What is the acceptable media fill frequency in relation to the number of shifts? For which of the following operations, broaching can be used? Built to bore holes, C. Typically bed mills with a long spindle throw, Answer: D.All of the above 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. In which operation, motion of job is rotary and motion of cutting tool is forwardtranslating? What do you know about our company? a) casting b) forming and shaping c) machining d) joining Answer: b Clarification: Forming and shaping process includes powder metallurgy. 5. What are your greatest strengths and weaknesses as a production worker? Answer: The total product is the sum of all the goods and services that a company makes with a certain number of inputs. 18) What are the softwares which can be useful in manufacturing unit? d) forming and shaping process. Engineering 2023 , FAQs Interview Questions. It can be obtained by dividing the total output by the total number of units of factor employed. 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. Following milling machine is used to cut gears A firm had multiple media fill failures. A turret mill has a ____ spindle and the table is moved ____ to the spindle axis to accomplishcutting. 21 Manufacturing Engineer Interview Questions and Answers 3. A. Any status label should be correct, legible, readily visible, and associated with the correct piece of equipment. 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. As a result, substitution is only possible at the kinks. a) honing and welding Powder metallurgy is a process in which material or shapes are made from or by using metal powders. Which of the following broaches are re-sharpened by grinding at rake faces? c) machining 5. Leptospira are obligate aerobes that use oxygen as the electron receptor and long-chain fatty acids as a major source of energy. Labor can be both physical and mental in nature. Good Manufacturing Practices Question 1: Consider the following statements: A. A firm has multiple media fill failures. <<2BFF83D679D3CA49AB51E34DB865E38F>]>> 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). b. The process of generating the invoice is basically to call an SSRS report which is the invoice and generate it for the user as a pdf in adobe embedded in the app. 96. 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. A. The following is used in Magnetic chucks What could be the source of contamination? Microorganisms may be objectionable for several reasons; for example, they: Establishing production time limits is an example of a control to prevent growth of objectionable microorganisms. What does the boring mean? Which of the following processes are included in finishing? Quality Control interview questions in electronic industry. The following is used to support too flexible job very close to the cutting edge. As a result, land includes land surface, soil fertility, light, air, heat, weather, climate, rainfall, rivers, streams, mountains, mines, forests, and fisheries, among other things. Answer: The ratio of input prices is shown by the slope of the iso-cost line. 14. A. Which drilling machine is used to perform drilling operation on the workpieces which are too heavy and also maybe too large to mount on worktable? 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. Examples of these kinds of status labels include mixing lot ###; clean, ready for use as of d/m/y; and not clean. Which of the following is not the type of finishing process? A. Question 02: What is the theory of production? To reduce machining time. Wrist motion of y involves. A. For example, it is expected that a conventional aseptic processing line that operates on two shifts be evaluated twice per year per shift and culminate in four media fills. A. Your IP: 2012). iron ore for making steel. 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. Use of single point cutting tool which are inexpensive and can be grounded to any shape, 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 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. However, in economics, the term labor has a broader meaning. Mention the most important products and services the company provides, the markets they operate in, and any significant projects they've been involved with recently. Because they cant be split up, these factors must be used in a minimum amount, even if the production scale is small. Synthetic oil is used as cutting fluid in grinding for Which type of job motion is there in drilling operation? The 50 most important "theory of production" questions and answers are as follows: Question 01: What is production? chapter: The isoquants kinks, which represent the fact that there are only a few production methods for each commodity, show how limited substitution is. 13. 50 Important Theory of Production Questions and Answers [With PDF Gang milling refers to the use of two or more milling cutters mounted on the ____ arbor in a____ milling set up. How many types of broaches are there? The offer the user the usual options to print. Answer: The following are the key features of labor in economics: Answer: Capital is another factor in production. 71. Wrought <.2% Steel .2-2.3% Cast Iron 2.3-4.2% . 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. 8. Question 43: What are the diminishing returns to scale? Objective tests can also be an effective teaching tool. 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). Milling, Answer: B.Grinding In broaching, generally the broach remains fixed and the workpiece travels providing cutting velocity. Good Manufacturing Practices MCQ [Free PDF] - Objective Question Answer 104. 100. 0000002875 00000 n Here are 10 general questions to expect during a production worker interview: Tell me about yourself. 17. A. Rotated by separate motors and at different speeds. 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). Some products, such as transdermal patches, are made using manufacturing processes with higher in-process material reject rates than for other products and processes. This question and answer (Q&A) document is intended to clarify key issues. The manufacturer is expected to have a sound rationale for its choices in this regard. The application of the principle of diminishing returns to land is obvious. Manufacturers are highly dependent on their raw material suppliers, to communicate with them effectively SCAR is used. (PDF) Manufacturing Account (With answers - Academia.edu What is the acceptable media fill frequency in relation to the number of shifts? 89. This should not of itself be a concern. 92. 5) Explain what is Six Sigma? Since we were encouraged to submit a proposal. 73. Cutting speed, 48. 74. 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. Diffusion type bonding is included in the of process of joining. Yes. The CGMP regulations provide the minimum legal requirements for conducting reliable operations (see 21 CFR part 211). A. 12. 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. will consistently produce a quality product ( 211.100). C. Basic oxygen process . 70 15 3, Answer: D.9 Shaping machine, Answer: D.None of these Production Management MCQ [Free PDF] - Objective Question Answer for PDF Management Accounting - ACCA Global There are several actions that could trigger this block including submitting a certain word or phrase, a SQL command or malformed data. 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. Clarification: This is false. As appropriate, preventive measures should be implemented during the product and process lifecycle. The exhaustibility of natural resources is another factor causing diminishing returns to scale. 86. 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? High efficiency deep grinding, 97. "Automation Of Manufacturing Process". This rule doesnt work when every factor is different. Jig borer are Investigation did not show any obvious causes. Steady rest, 20. 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. In end mill cutter, chips are pulled up the a) machining process Why is FDA concerned about human topical antiseptic drug products? Question 40: What are the reasons for increasing returns to scale? Additionally, confidence in the API manufacturing process may be gained by enhanced sampling (larger sample size representative of thebatch) and perhaps the testing of additional attributes. A. Subtractive process: B. 1.1 Introduction Scallan-01.qxd 2/24/03 2:38 PM Page 1 Answer: c In economics, labor refers to both physical and mental labor. Answer: The following are the key features of the land: Answer: In general, the term labor refers only to physical labor. The business maximizes the efficiency of its inputs. The CGMP regulations provide the minimum legal requirements for conducting reliable operations (see 21 CFR part 211). Explain different types of Rolling Mills. Question 17: What is the long-run production function? Thanks PDF Manufacturing Interview Questions - Skillful 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.
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