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Eragon
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This article is about the novel by Christopher Paolini. For other uses of the name, see Eragon (disambiguation). For the historical kingdom and region of modern Spain, see Aragon. For the J.R.R. Tolkien character, see Aragorn.
Eragon
Knopf edition cover by John Jude Palencar, featuring the blue dragon Saphira
Author
Christopher Paolini
Cover artist
John Jude Palencar
Country
United States
Language
English
Series
Inheritance Cycle
Genre
Young adult
Fantasy novel
Dystopia
Publisher
Paolini LLC (first edition), Alfred A. Knopf
Publication date
2002 (first edition), August 26, 2003 (Knopf)
Media type
Print (hardback & paperback) and audio-CD
Pages
509 (Knopf)
544 (Paolini LLC)
ISBN
0-375-82668-8 (First Knopf edition) ISBN 0-9666213-3-6 (Paolini LLC)
OCLC
52251450
Dewey Decimal
[Fic] 21
LC Class
PZ7.P19535 Er 2003
Followed by
Eldest
Copies sold: 24.55 million
Eragon is the first novel in the Inheritance Cycle by Christopher Paolini. After writing the first draft for a year, Paolini spent a second year rewriting and fleshing out the story and characters. His parents saw the final manuscript and in 2001 decided to self-publish Eragon;[1] Paolini spent a year traveling around the United States promoting the novel. By chance, the book was discovered by Carl Hiaasen, who got it re-published by Alfred A. Knopf. The re-published version was released on August 26, 2003.
The book tells the story of a farm boy named Eragon, who finds a mysterious stone in the mountains. Not knowing the stone's origin or worth, he attempts to use it as payment to a butcher. A dragon he later names Saphira hatches from the stone, which was really an egg. When the evil King Galbatorix finds out the general location of the egg he sends the Ra'zac to acquire it. By that time Saphira had been growing for a while and takes Eragon to the Spine after Ra'zac appear in their village Carvahall. Eragon and Saphira are forced to flee from their hometown, with a storyteller called Brom, and decide to search for the Varden, a group of rebels who want the downfall of Galbatorix.
Critics of Eragon often point out its similarities to other works such as Earthsea, Dragonlance, and Star Wars.[2] Reviewers have also called the book a notable achievement for such a young author as Paolini.
Eragon was the third-best-selling children's hardback book of 2003, and the second-best-selling paperback of 2005. It placed on the New York Times Children's Books Best Seller list for 121 weeks and was adapted as a feature film of the same name that was released on December 15, 2006.
Contents
[hide]
1 Background
1.1 Origins and publication
1.2 Inspiration and influences
2 Plot summary
3 Reception
4 Film adaptation
5 References
6 External links
Background[edit]
Origins and publication[edit]
Christopher Paolini started reading fantasy books when he was 10 years old. At the age of 14, as a hobby, he started writing the first novel in a series of four books, but he could not get beyond a few pages because he had "no idea" where he was going. He began reading everything he could about the "art of writing", and then plotted the whole Inheritance Cycle book series. After a month of planning out the series, he started writing the draft of Eragon by hand. It was finished a year later, and Paolini began writing the "real" version of the book.[3] After another year of editing, Paolini's parents saw the final manuscript. They immediately saw its potential and decided to publish the book through their small, home-based publishing company, Paolini International.[4] Paolini created the cover art for this edition of Eragon, which featured Saphira's eye on the cover. He also drew the maps inside the book.[5]
Paolini and his family toured across the United States promoting the book. Over 135 talks were given at bookshops, libraries, and schools, many with Paolini dressed up in a medieval costume; but the book did not receive much attention. Paolini said he "would stand behind a table in my costume talking all day without a break – and would sell maybe forty books in eight hours if I did really well. [...] It was a very stressful experience. I couldn't have gone on for very much longer."[3] In the summer of 2002, American novelist Carl Hiaasen was on vacation in one of the cities that Paolini gave a talk in. While there, Hiaasen's stepson bought a copy of Eragon that he "immediately loved".[3] He showed it to Hiaasen, who brought the book to the attention of the publishing house Alfred A. Knopf. Michelle Frey, executive editor at Knopf, contacted Paolini and his family to ask if they were interested in having Knopf publish Eragon. The answer was yes, and after another round of editing, Knopf published Eragon in August 2003, with a new cover, drawn by John Jude Palencar.[6]
Inspiration and influences[edit]
An illustration of Beowulf fighting the dragon (1908). Paolini received much inspiration from old epic poems.
Paolini cites old myths, folk tales, medieval stories, the epic poem Beowulf, and authors J. R. R. Tolkien and Eric Rücker Eddison as his biggest influences in writing. Other literary influences include David Eddings, Andre Norton, Brian Jacques, Anne McCaffrey, Raymond E. Feist, Mervyn Peake, Ursula K. Le Guin, Frank Herbert,[7] Philip Pullman, and Garth Nix. In Eragon, Paolini "deliberately" included the "archetypal ingredients" of a fantasy book – a quest, a journey of experience, revenge, romance, betrayal, and a "special" sword.[3]
The ancient language used by the elves in Eragon is based "almost entirely" on Old Norse, German, Anglo Saxon, and Russian myth.[8] Paolini commented: "[I] did a god-awful amount of research into the subject when I was composing it. I found that it gave the world a much richer feel, a much older feel, using these words that had been around for centuries and centuries. I had a lot of fun with that."[9] Picking the right names for the characters and places was a process that could take "days, weeks, or even years". Paolini said: "if I have difficulty choosing the correct moniker, I use a placeholder name until a replacement suggests itself."[4] He added that he was "really lucky" with the name Eragon, "because it's just dragon with one letter changed." Also, Paolini commented that he thought of both parts of the name "Eragon" - "era" and "gone" - as if the name itself changes the era in which the character lives. He thought the name fit the book perfectly, but some of the other names caused him "real headaches".[9]
Paolini received inspiration from Paradise Valley, Montana (Emigrant Peak pictured, as viewed from west bank of Yellowstone River)
The landscape in Eragon is based on the "wild territory" of Paolini's home state, Montana.[3] He said in an interview: "I go hiking a lot, and oftentimes when I'm in the forest or in the mountains, sitting down and seeing some of those little details makes the difference between having an okay description and having a unique description."[9] Paolini also said that Paradise Valley, Montana is "one of the main sources" of his inspiration for the landscape in the book (Eragon takes place in the fictional continent Alagaësia). Paolini "roughed out" the main history of the land before he wrote the book, but he did not draw a map of it until it became important to see where Eragon was traveling. He then started to get history and plot ideas from seeing the landscape depicted.[9]
Paolini chose to have Eragon mature throughout the book because, "for one thing, it's one of the archetypal fantasy elements". He thought Eragon's growth and maturation throughout the book "sort of mirrored my own growing abilities as a writer and as a person, too. So it was a very personal choice for that book."[9] Eragon's dragon, Saphira, was imagined as "the perfect friend" by Paolini.[3] He decided to go in a more "human direction" with her because she is raised away from her own species, in "close mental contact" with a human. "I considered making the dragon more dragon-like, if you will, in its own society, but I haven't had a chance to explore that. I went with a more human element with Saphira while still trying to get a bit of the magic, the alien, of her race."[9] Paolini made Saphira the "best friend anyone could have: loyal, funny, brave, intelligent, and noble. She transcended that, however, and became her own person, fiercely independent and proud."[4] Saphira's blue tinted vision was in turn inspired by Paolini's own color-blindness.[10]
Paolini added in archetypal elements of a fantasy novel like a quest, a journey of experience, revenge, romance, betrayal, and a "special" sword.[3] The book is described as a fantasy, and Booklist observed: "Paolini knows the genre well—his lush tale is full of recognizable fantasy elements and conventions".[11] Kirkus Review called the book a "high fantasy";[11] other reviewers have compared it to other books of the fantasy genre, such as Star Wars and Lord of the Rings, and in some instances stated Eragon's plot is too similar to those other fantasy novels.[2]
Plot summary[edit]
See also: List of Inheritance Cycle characters
A shade named Durza, along with a group of urgals, ambushes a party of three elves. After he and the urgals kill the other elves, Durza attempts to steal an egg, that one of the female elves carries, but is foiled when she causes it to vanish. Infuriated, he renders her unconscious with a ball of fire and abducts her.
Eragon is a fifteen-year-old boy who has lived with his uncle Garrow and cousin Roran (Roran Stronghammer) on a farm near the village of Carvahall, ever since his mother Selena, Garrow's sister, left him there right after his birth. While hunting in the Spine, Eragon is surprised to see the blue dragon egg, which he believes to be a stone, appear in front of him. A few months later, Eragon witnesses a baby dragon hatch from the egg. Eragon names the dragon Saphira. He raises the dragon in secret until two of King Galbatorix's servants, the Ra'zac, come to Carvahall; though it is later revealed that they weren't looking for the egg at first. Eragon and Saphira manage to escape by hiding in the Spine, but Garrow is fatally wounded and the house and farm are burned down by the Ra'zac. Once Garrow dies, Eragon is left with no reason to stay in Carvahall, so he goes after the Ra'zac with his newly hatched dragon, seeking vengeance for the destruction of his home and his uncle's death. He is accompanied by Brom, an elderly storyteller, who provides Eragon with the sword Zar'roc and insists on helping him and Saphira.
Eragon becomes a Dragon Rider through his bond with Saphira. He is the only known Rider in Alagaësia other than King Galbatorix, who, with the help of the now-dead Forsworn, a group of thirteen dragon riders loyal to Galbatorix, killed every other Rider a hundred years ago. On the journey, Brom teaches Eragon sword fighting, magic, the ancient elvish language, and the ways of the Dragon Riders. Their travels bring them to the city of Teirm, where they meet with Brom's friend Jeod. Eragon's fortune is told by the witch Angela, and her companion, the werecat Solembum, gives Eragon some mysterious advice. With Jeod's help, they are able to track the Ra'zac to the southern city of Dras-Leona. Although they manage to infiltrate the city, Eragon encounters the Ra'zac in a cathedral and he and Brom are forced to flee. Later that night, their camp is ambushed by the Ra'zac. A stranger named Murtagh rescues them, but Brom is gravely injured. Saphira watches over Brom as the night progresses, yet when morning comes they realize there is nothing they can do to save him. Brom gives Eragon his blessing, reveals that he was also once a dragon rider and that his dragon's name was Saphira, and dies. Saphira then encases Brom in a tomb made of a diamond.
Murtagh becomes Eragon's new companion and they travel to the city Gil'ead to find information on how to find the Varden, a group of rebels who want to see the downfall of Galbatorix. While stopping near Gil'ead, Eragon is captured and imprisoned in the same jail that holds a woman he has been having dreams about. As she is being dragged past she is revealed as an elf when her pointed ears are uncovered. Murtagh and Saphira stage a rescue, and Eragon escapes with the unconscious elf. During the escape, Eragon and Murtagh battle with Durza. Murtagh shoots Durza between the eyes with an arrow, and the Shade disappears in a cloud of mist. Having escaped, they run off. Eragon succeeds in communicating with the elf, whose name is revealed as Arya, and learns the location of the Varden. After some arguing, Murtagh decides to still travel with Eragon to the Varden but is still wary of them.
An army of Kull (Urgals who can grow up to 8 feet) reach Eragon right outside the Varden's entrance, but are driven off with the help of the Varden, who escort Eragon, Saphira, Murtagh, and Arya to Farthen Dûr the mountain hideout of the varden. When they arrive in Farthen Dûr, Eragon is led to the leader of the Varden, Ajihad. Ajihad imprisons Murtagh after he refuses to allow his mind to be read to determine if he is a friend or a foe to the Varden. Eragon is told by Ajihad that Durza was not destroyed by Murtagh's arrow, because the only way to kill a Shade is with a stab through the heart. Orik, nephew of the dwarf King Hrothgar, is appointed as Eragon and Saphira's guide. Orik shows them a place to stay and introduces them to Hrothgar. Eragon also meets Ajihad's daughter, Nasuada, and Ajihad's right-hand man, Jörmundur. He also runs into Angela and Solembum, who have arrived in Tronjheim, and visits Murtagh in his prison. He is tested by two magicians, The Twins, as well as Arya.
Eragon and the Varden are then attacked by the Kull, as well as the rest of the Urgal army. Eragon personally battles Durza again, and succeeds in stabbing him in the heart with Zar'roc, but Durza slashes a deep cut like Murtagh's on his back. He then passes out, and is visited telepathically by a stranger while he is unconscious who tells Eragon to visit him in the Elven capital, Ellesméra.
Reception[edit]
Eragon received generally mixed reviews and was criticized for its derivative nature. Liz Rosenberg of The New York Times Book Review criticized Eragon for having "clichéd descriptions", "B-movie dialogue", "awkward and gangly" prose." However, she concluded the review by noting that "for all its flaws, it is an authentic work of great talent".[12] School Library Journal wrote that in Eragon "sometimes the magic solutions are just too convenient for getting out of difficult situations".[13] Common Sense Media called Eragon's dialogue "long-winded" and "clichéd", with a plot "straight out of Star Wars by way of The Lord of the Rings, with bits of other great fantasies thrown in here and there." The website did concede that the book is a notable achievement for such a young author, and that it would be "appreciated" by younger fans.[2]
Favorable reviews of Eragon often focused on the book's characters and plot. IGN's Matt Casamassina called the book "entertaining", and added that "Paolini demonstrates that he understands how to hold the reader's eyes and this is what ultimately separates Eragon from countless other me-too fantasy novels."[14] Chris Lawrence of About.com thought the book had all the "traditional ingredients" that make a fantasy novel "enjoyable". The book was a "fun read" for him because it is "quick and exciting" and "packed" with action and magic. Lawrence concluded his review by giving the book a rating of 3.8/5, commenting that "the characters are interesting, the plot is engrossing, and you know the good guy will win in the end."[15]
Eragon was the third best-selling children's hardback book of 2003,[16] and the second best-selling children's paperback of 2005.[17] It placed on the New York Times Children's Books Best Seller list for 121 weeks.[18] In 2006, the novel was awarded with a Nene Award by the children of Hawaii.[19] It won the Rebecca Caudill Young Reader's Book Award[20] and the Young Reader's Choice Award the same year.[21]
Film adaptation[edit]
Main article: Eragon (film)
Aerial photography of the Ság mountain, which served as the backdrop for Farthen Dûr in the film adaptation of the book.
A film adaptation of Eragon was released in the United States on December 15, 2006. Plans to create the film were first announced in February 2004, when 20th Century Fox purchased the rights to Eragon. The film was directed by first-timer Stefen Fangmeier, and written by Peter Buchman.[22] Edward Speleers was selected for the role of Eragon.[23] Over the following months, Jeremy Irons, John Malkovich, Chris Egan and Djimon Hounsou were all confirmed as joining the cast.[24] Principal photography for the film took place in Hungary and Slovakia.[25]
The film received mostly negative reviews, garnering a 16% approval rating at Rotten Tomatoes;[26] the tenth worst of 2006.[27] The Seattle Times described it as "technically accomplished, but fairly lifeless and at times a bit silly".[28] The Hollywood Reporter said the world of Eragon was "without much texture or depth".[29] The story was labelled "derivative" by The Washington Post,[30] and "generic" by the Las Vegas Weekly.[31] Newsday stressed this point further, asserting that only "nine-year-olds with no knowledge whatsoever of any of the six Star Wars movies" would find the film original.[32] The acting was called "lame" by the Washington Post,[30] as well as "stilted" and "lifeless" by the Orlando Weekly.[33] The dialogue was also criticized: MSNBC labelled it "silly";[34] the Las Vegas Weekly called it "wooden".[31] Positive reviews described the film as "fun"[35] and "the stuff boys' fantasies are made of".[36] The CGI work was called "imaginative" and Saphira was called a "magnificent creation".[37] Paolini stated he enjoyed the film, particularly praising the performances of Jeremy Irons and Ed Speleers.[38]
Eragon grossed approximately $75 million in the United States and $173.9 million elsewhere, totaling $249 million worldwide.[39] It is the fifth highest-grossing film with a dragon at its focal point,[40] and the sixth highest-grossing film of the sword and sorcery subgenre.[41] Eragon was in release for seventeen weeks in the United States, opening on December 15, 2006 and closing on April 9, 2007.[42] It opened in 3,020 theaters, earning $8.7 million on opening day and $23.2 million across opening weekend, ranking second behind The Pursuit of Happyness.[43] Eragon’s $75 million total United States gross was the thirty-first highest for 2006.[44] The film earned $150 million in its opening weekend across 76 overseas markets, making it the #1 film worldwide.[45] The film’s $249 million total worldwide gross was the sixteenth highest for 2006.[46]
References[edit]
Jump up ^ "About the Author". Alagaesia.com. Retrieved 2017-03-23.
^ Jump up to: a b c Berman, Matt. "Eragon Book Review and Rating". Common Sense Media. Retrieved 2009-01-31.
^ Jump up to: a b c d e f g Spring, Kit (2004-01-26). "Elf and efficiency". The Observer. Retrieved 2009-01-31.
^ Jump up to: a b c Saichek, Wiley (September 2003). "Christopher Paolini interview". Teenreads.com. Retrieved 2009-01-31.
Jump up ^ Paolini, Christopher (2002). Eragon. Paolini International LLC. ISBN 0-9666213-3-6. OCLC 49993776.
Jump up ^ "The Author". Alagaesia.com. Retrieved 2009-01-31.
Jump up ^ "Christopher Paolini Q&A". Shurtugal.com. Archived from the original on 2008-05-14. Retrieved 2009-01-31.
Jump up ^ Jana Schulman, "Retelling Old Tales: Germanic Myth and Language in Christopher Paolini's Eragon," The Year's Work in Medieval-ism 25 (2010), 33-41.
^ Jump up to: a b c d e f Weich, Dave (2003-07-31). "Philip Pullman, Tamora Pierce, and Christopher Paolini Talk Fantasy Fiction". Powell's Books. Archived from the original on 2009-02-22. Retrieved 2009-01-31.
Jump up ^ https://twitter.com/paolini/statuses/467683317202952192
^ Jump up to: a b "Reviews: Eragon BETA". catalog.dclibrary.org. Archived from the original on 2013-04-14. Retrieved 2010-09-26.
Jump up ^ Rosenberg, Liz (2003-11-16). "The Egg and Him". The New York Times. Retrieved 2009-01-31.
Jump up ^ Rogers, Susan. "Amazon.com Eragon". School Library Journal. Retrieved 2011-11-09.
Jump up ^ Casamassina, Matt (2004-03-01). "Book Review: Eragon". IGN. Retrieved 2009-01-31.
Jump up ^ Lawrence, Chris. "Eragon (Inheritance, Book 1)". About.com. Retrieved 2009-01-31.
Jump up ^ "Best-Selling Children's Books, 2003". Publishers Weekly. Retrieved 2009-01-31.
Jump up ^ "Best-Selling Children's Books, 2005". Publishers Weekly. Retrieved 2009-01-31.
Jump up ^ "New York Times Best Seller List". The New York Times. 2008-01-06.
Jump up ^ "Nene Award Website - 2006 winner". R.E.A.D for Nene. Retrieved 2009-01-29.
Jump up ^ "2006 Winner — Eragon". Rebecca Caudill Young Reader's Book Award. Retrieved 2009-01-29.
Jump up ^ "YRCA Past Winners". Pacific Northwest Library Association. Retrieved 2011-02-03.
Jump up ^ "Eragon". Internet Movie Database. Retrieved 2007-05-01.
Jump up ^ Lyall, Sarah (2006-07-18). "He Was a Teenage Spy, Surrounded by Treacherous Adults". The New York Times. Retrieved 2009-01-31.
Jump up ^ Parsons, Ryan (2006-08-15). "More Eragon Stills!". CanMag. Retrieved 2007-11-06.
Jump up ^ "Silver Screen Destinations: Eragon". AdventureTravelLogue. Retrieved 2009-01-31.
Jump up ^ "Eragon". Rotten Tomatoes. Archived from the original on 2009-03-04. Retrieved 2012-05-17.
Jump up ^ "8th Annual Golden Tomatoes Awards". Rotten Tomatoes. Archived from the original on 2007-11-14. Retrieved 2007-11-06.
Jump up ^ Macdonald, Moira (2006-12-14). "Even preteens aren't slayed by familiar tale". The Seattle Times. Archived from the original on 2007-11-14. Retrieved 2007-11-06.
Jump up ^ Honeycutt, Kirk (2006-12-14). "Eragon". The Hollywood Reporter. Archived from the original on 2007-10-15. Retrieved 2007-11-06.
^ Jump up to: a b Hunter, Stephen. "Eragon". The Washington Post. Retrieved 2007-11-06.
^ Jump up to: a b Bell, Josh (2006-12-14). "Lord of the Wings". Las Vegas Weekly. Archived from the original on 2008-01-02. Retrieved 2007-11-06.
Jump up ^ Seymour, Gene (2006-12-15). "Eragon". Newsday. Archived from the original on 2007-09-30. Retrieved 2007-11-06.
Jump up ^ Ferguson, Jason (2006-12-14). "Eragon". Orlando Weekly. Retrieved 2007-11-06.
Jump up ^ Germain, David (2006-12-13). "'Eragon' is a 'Star Wars' wannabe". MSNBC. Retrieved 2007-11-06.
Jump up ^ Smith, Michael. "This Week's Movie Review". Crazed Fanboy. Retrieved 2009-01-29.
Jump up ^ "Eragon". Urban Cinefile. Retrieved 2009-01-29.
Jump up ^ Arnold, William (2006-12-15). "All that's missing are the hobbits". Seattle Post-Intelligencer. Retrieved 2009-01-29.
Jump up ^ "Movie Viewer". Shurtugal.com. Archived from the original on 2007-09-27. Retrieved 2009-01-29.
Jump up ^ "Eragon (2006)". Box Office Mojo. Retrieved 2009-01-29.
Jump up ^ "Dragon- Focal Point of Movie Movies". Box Office Mojo. Retrieved 2016-11-22.
Jump up ^ "Sword and Sorcery Movies". Box Office Mojo. Retrieved 2012-03-02.
Jump up ^ "Eragon (2006)". Box Office Mojo. Retrieved 2009-01-29.
Jump up ^ "Weekend Box Office Results for December 15–17, 2006". Box Office Mojo. Retrieved 2009-01-29.
Jump up ^ "2006 Yearly Box Office Results". Box Office Mojo. Retrieved 2009-01-29.
Jump up ^ Segers, Frank (2006-12-18). "'Eragon' soars atop overseas box office". The Hollywood Reporter. Archived from the original on 2010-03-28. Retrieved 2009-01-29.
Jump up ^ "2006 Yearly Box Office Results". Box Office Mojo. Retrieved 2009-01-29.
External links[edit]
Wikiquote has quotations related to: Eragon
Eragon at the official website
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Emerald ash borer
From Wikipedia, the free encyclopedia
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Emerald ash borer
Scientific classification
Kingdom: Animalia
Clade: Euarthropoda
Class: Insecta
Order: Coleoptera
Family: Buprestidae
Genus: Agrilus
Species: A. planipennis
Binomial name
Agrilus planipennis
Fairmaire, 1888
Synonyms
Agrilus feretrius Obenberger
Agrilus marcopoli Obenberger[1]
Agrilus planipennis, commonly known as the emerald ash borer, is a green buprestid or jewel beetle native to northeastern Asia that feeds on ash species. Females lay eggs in bark crevices on ash trees, and larvae feed underneath the bark of ash trees to emerge as adults in one to two years. In its native range, it is typically found at low densities and does not cause significant damage to trees native to the area. Outside its native range, it is an invasive species and is highly destructive to ash trees native to northwest Europe and North America. Prior to being found in North America, very little was known about emerald ash borer in its native range; this has resulted in much of the research on its biology being focused in North America. Local governments in North America are attempting to control it by monitoring its spread, diversifying tree species, insecticides, and biological control.
Contents
[hide]
1 History
2 Identification
3 Life cycle
4 Range
5 Host plants
6 As an invasive species
6.1 Invasiveness and spread
6.2 Environmental and economic impacts
6.3 Monitoring
6.4 Management
6.4.1 Quarantine and tree removal
6.4.2 Insecticides
6.4.3 Biological control
7 See also
8 References
9 External links
History[edit]
The French priest and naturalist Armand David collected a specimen of the species during one of the trips he took through imperial China in the 1860s and 1870s. He found the beetle in Beijing and sent it back to France, where the first brief description of Agrilus planipennis by the entomologist Léon Fairmaire was published in the Revue d'Entomologie in 1888.[2] Unaware of Fairmaire's description, a separate description naming the species as Agrilus marcopoli was published in 1930 by Jan Obenberger.[2]
Identification[edit]
Adult beetles are typically bright metallic green and about 8.5 millimeters (0.33 in) long and 1.6 millimeters (0.063 in) wide. Elytra are typically a darker green, but can also have copper hues. Emerald ash borer is the only North American species of Agrilus with a bright red upper abdomen when viewed with the wings and elytra spread. The species also has a small spine found at the tip of the abdomen and serrate antennae that begin at the fourth antennal segment.[3] Adults beetles of other species can often be misidentified by the public.[4]
Life cycle[edit]
The emerald ash borer life cycle can occur over one or two years depending on the time of year of oviposition, the health of the tree, and temperature.[5]
After 400–500 accumulated degree-days above 10 °C (50 °F), adults begin to emerge from trees in late spring, and peak emergence occurs around 1000 degree-days. After emergence, adults feed for one week on ash leaves in the canopy before mating, but cause little defoliation in the process.[6] Males hover around trees, locate females by visual cues, and drop directly onto the female to mate; mating can last 50 minutes, and females may mate with multiple males over their lifespan.[7] A typical female can live around six weeks and lay approximately 40–70 eggs, but females that live longer can lay up to 200 eggs.[6]
Eggs are deposited between bark crevices, flakes, or cracks and hatch about two weeks later. Eggs are approximately 0.6 to 1.0 millimeter (0.02 to 0.04 in) in diameter, and are initially white, but later turn reddish-brown if fertile.[6][5] After hatching, larvae chew through the bark to the inner phloem, cambium, and outer xylem where they feed and develop.[7] Emerald ash borer has four larval instars. By feeding, larvae create long serpentine galleries. Fully mature fourth-instar larvae are 26 to 32 millimeters (1.0 to 1.3 in) long.[5] In fall, mature fourth-instars excavate chambers about 1.25 centimeters (0.49 in) into the sapwood or outer bark where they fold into a J-shape.[7] These J-shaped larvae shorten into prepupae and develop into pupae and adults the following spring. To exit the tree, adults chew holes from their chamber through the bark, which leaves a characteristic D-shaped exit hole. Immature larvae can overwinter in their larval gallery, but can require an additional summer of feeding before overwintering again and emerging as adults the following spring.[5] This two-year life cycle is more common in cool climates, such as European Russia.[8]
Larva
Pupa removed from its pupal chamber.
Adults exit the tree from D-shaped holes.
Dorsal view of adult with elytra and wings spread.
Underside of an adult emerald ash borer.
Range[edit]
Native range of emerald ash borer in eastern Asia and introduced range in European Russia as of 2013.
The native range of the emerald ash borer is temperate northeastern Asia, which includes Russia, Mongolia, northern China, Japan, and Korea.[9][8]
The beetle is invasive in North America where it has a core population in Michigan and surrounding states and provinces. Populations are more scattered outside the core area, and the edges of its known distribution range north to the upper peninsula of Michigan, south to northern Louisiana, west to Colorado, and east to Massachusetts [10] In northern Europe, a population was found in Moscow, Russia in 2003.[8] From 2003 to 2016, this population has spread west towards Sweden at 40 km (25 mi) per year and is expected to reach central Europe between 2031 and 2036.[11][12][8]
Host plants[edit]
In its native range, emerald ash borer is only a nuisance pest on native trees, as population densities typically do not reach levels lethal to healthy trees.[13] In China, it infests native F. chinensis, F. mandshurica, and F. rhynchophylla; in Japan it also infests F. japonica and F. lanuginosa.[8]
Emerald ash borer primarily infest and can cause significant damage to ash species including green ash (Fraxinus pennsylvanica), black ash (Fraxinus nigra), white ash (Fraxinus americana), and blue ash (Fraxinus quadrangulata) in North America.[14] In Europe, Fraxinus excelsior is the main ash species colonized by EAB.[8] Ash susceptibility can vary due to the attractiveness of chemical volatiles to adults, or the ability of larvae to detoxify phenolic compounds.[7] Emerald ash borer has also been found infesting white fringe tree in North America, which is a non-ash host, but it is unclear whether the trees were healthy when first infested, or were already in decline due to drought.[7][15]
Adults prefer to lay eggs on open grown or stressed ash, but readily lay eggs on healthy trees amongst other tree species.[7] Young trees with bark between 1.5 millimeters (0.059 in) to 5 millimeters (0.20 in) are preferred.[8] Both males and females use leaf volatiles and sesquiterpenes in the bark to locate hosts.[7] Damage occurs in infested trees due to larval feeding. The serpentine feeding galleries of the larvae disrupt the flow of nutrients and water, effectively girdling (killing) the tree as it is no longer be able to transport sufficient water and nutrients to the leaves to survive.[6]
As an invasive species[edit]
A green ash killed by emerald ash borers
Outside its native range, emerald ash borer is an invasive species that is highly destructive to ash trees in its introduced range.[16] Prior to emerald ash borer being found in North America, very little was known about emerald ash borer in its native range aside from a short description of life-history traits and taxonomic descriptions, which resulted in focused research on its biology in North America.[6] Since its accidental introduction into the United States and Canada in the 1990s and its subsequent detection in 2002 in Canton, Michigan, it has since spread other parts of the North America.[17] It is suspected that it was introduced from overseas in shipping materials such as packing crates.[18]
Invasiveness and spread[edit]
Without factors that would normally suppress emerald ash borer populations in its native range (e.g., resistant trees, predators, and parasitoid wasps), populations can quickly rise to damaging levels.[6] After initial infestation, all ash trees are expected to die in an area within 10 years without control measures.[6] Every North American ash species has susceptibility to emerald ash borer, as North American species planted in China also have high mortality due to infestations, but some Chinese ash species are resistant.[19][20]
Green ash and black ash trees are preferred by emerald ash borer. White ash is also killed rapidly, but usually only after all green and black ash trees are eliminated. Blue ash displays some resistance to the emerald ash borer by forming callus tissue around emerald ash borer galleries, but is eventually killed.[21] Many of the specialized predators and parasitoids that suppressed emerald ash borer in Asia were not present in North America. Predators and parasitoids native to North America do not sufficiently suppress emerald ash borer, so populations continue to grow.[6] Emerald ash borer populations can spread between 2.5 to 80 km (1.6 to 49.7 mi) a year.[6] It primarily spreads through flight or by transportation of ash bark containing products such as firewood or nursery stock, which allows it to reach new areas and create satellite populations outside of the main infestation.[6][8]
Other factors can limit spread. Winter temperatures of approximately −38 °C (−36 °F) limit range expansion.,[22][23] and overwintering emerald ash borer survive down to average temperatures of −30 °C (−22 °F) due to antifreeze chemicals in the body and insulation provided by tree bark.[8] Larvae can also survive high heat up to 53 °C (127 °F).[8]
North American predators and parasitoids can occasionally cause high emerald ash borer mortality, but generally offer only limited control. Mortality due to native woodpeckers is variable. Parasitism by parasitoids such as Atanycolus cappaerti can be high, but overall such control is generally low.[6]
Environmental and economic impacts[edit]
Emerald ash borer threatens the entire North American Fraxinus genus. It has killed at least tens of millions of ash trees so far and threatens to kill most of the 8.7 billion ash trees throughout North America.[10] Emerald ash borer kills young trees several years before reaching their seeding age of 10 years.[6] In both North America and Europe, the loss of ash from an ecosystem can result in increased numbers of invasive plants, changes in soil nutrients, and effects on species that feed on ash.[8]
Damage and efforts to control the spread of emerald ash borer have affected businesses that sell ash trees or wood products, property owners, and local or state governments.[6] Quarantines can limit the transport of ash trees and products, but economic impacts are especially high for urban and residential areas due to treatment or removal costs and decreased land value from dying trees.[24] Costs for managing these trees can fall upon homeowners or local municipalities. For municipalities, removing large numbers of dead or infested trees at once is costly, so slowing down the rate at which trees die through removing known infested trees and treating trees with insecticides can allow local governments more time to plan, remove, and replace trees that would eventually die. This strategy saves money as it would cost $10.7 billion in urban areas of 25 states between 2009–2019, while removing and replacing all ash trees in these same areas at once would cost $25 billion.[24][25] Some urban areas such as Minneapolis, Minnesota, have large amounts of ash with slightly more than 20% of their urban forest as ash.[26]
Monitoring[edit]
In areas where emerald ash borer has not yet been detected, surveys are used to monitor for new infestations. Visual surveys are used to find ash trees displaying emerald ash borer damage, and traps with colors attractive to emerald ash borer, such as purple or green, are hung in trees as part of a monitoring program.[6] These traps can also have volatile pheromones applied to them that attract primarily males.[7]
A purple trap used for determining the extent of the invasion
Sometimes trees are also girdled to act as trap trees to monitor for emerald ash borer. The stressed tree attracts egg-laying females in the spring and trees can be debarked in the fall to search for larvae.[6] If detected, an area is often placed under a quarantine to prevent infested wood material from causing new infestations.[17][6] Further control measures are then taken within the area to slow population growth by reducing beetle numbers, preventing them from reaching reproductive maturity and dispersing, and reducing the abundance of ash trees.[6]
Government agencies in both the USA and Canada have utilized a native species of parasitoid wasp, Cerceris fumipennis, as a means of detecting areas to which emerald ash borer has spread. The females of these wasps hunt other jewel beetles and emerald ash borer if it is present. The wasps stun the beetles and carry them back to their burrows in the ground where they are stored until the wasps’ eggs hatch and the wasp larvae feed on the beetles. Volunteers catch the wasps as they return to their burrows carrying the beetles to determine whether emerald ash borer is present. This methodology is known as biological surveillance, as opposed to biological control, because it does not appear that the wasps have a significant negative impact on emerald ash borer populations.[27]
Management[edit]
In areas where emerald ash borer is non-native and invasive, quarantines, infested tree removal, insecticides, and biological control are used to reduce damage to ash trees.
North American emerald ash borer finds and quarantine locations as of January 3, 2017.
Quarantine and tree removal[edit]
Once an infestation is detected, quarantines are typically imposed by state or national government agencies disallowing transport of ash firewood or live plants outside of these areas without permits indicating the material has been inspected or treated (i.e., heat treatment or wood chipping) to ensure no live emerald ash borer are present in the bark and phloem.[17][28] In urban areas, trees are often removed once an infestation is found to reduce emerald ash borer population densities and the likelihood of further spread. Urban ash are typically replaced with non-ash species such as maple, oak, or linden to limit food sources.[29] In rural areas, trees can be harvested for lumber or firewood to reduce ash stand density, but quarantines may apply for this material, especially in areas where the material could be infested.[30]
Kentucky Extension specialists suggest selecting uncommon species to replace removed ashes in the landscape.[31] Previous generations created monocultures by planting ash trees in an overabundance, a factor in the extent of the devastation caused by the emerald ash borer. Favoring instead a diversity in species helps keep urban forests healthy. University of Kentucky scientists suggest choosing monotypic species such as the pawpaw, yellowwood, Franklin tree, Kentucky coffeetree, Osage orange, sourwood, and baldcypress.
Insecticides[edit]
Insecticides with active ingredients such as azadirachtin, imidacloprid, emamectin benzoate, and dinotefuran are currently used since they are systemic (i.e., incorporated into the tree) and remain effective for one to three years depending on the product.[6][32][33] Insecticides are typically only considered a viable option in urban areas with high value trees near an infestation.[32] Ash trees are primarily treated by direct injection into the tree or soil drench. Some insecticides cannot be applied by homeowners and must be applied by licensed applicators. Initially, tree injections do not compromise tree health, but over many years drilling and chemical wounds can compromise the tree's health.[34] Damage from emerald ash borer can continue to increase over time even with insecticide applications.[6] Insecticide treatments are not feasible for large forested areas outside of urban areas.[6]
Biological control[edit]
Tetrastichus planipennisi, a parasitoid wasp used as a biological control agent
The native range of emerald ash borer in Asia was surveyed for parasitoid species that parasitize emerald ash borer and do not attack other insect species in the hope they would suppress populations when released in North America.[35] Three species imported from China were approved for release by the USDA in 2007 and in Canada in 2013: Spathius agrili, Tetrastichus planipennisi, and Oobius agrili, while Spathius galinae was approved for release in 2015.[36][37] Excluding Spathius galinae, which has only recently been released, the other three species have been documented parasitizing emerald ash borer larvae one year after release, indicating that they survived the winter, but establishment varied among species and locations.[37] Tetrastichus planipennisi and Oobius agrili established and have had increasing populations in Michigan since 2008; Spathius agrili has had lower establishment success in North America, which could be due to a lack of available emerald ash borer larvae at the time of adult emergence in spring, limited cold tolerance, and better suitability to regions of North America below the 40th parallel.[37]
The USDA is also assessing the application of Beauveria bassiana, an insect fungal pathogen, for controlling emerald ash borer in conjunction with parasitoid wasps.[38]
See also[edit]
Insects portal
Forest integrated pest management
Forest pathology
Invasive species
References[edit]
Jump up ^ "Data Sheets on Quarantine Pests: Agrilus planipennis" (PDF). OEPP/EPPO Bulletin. European and Mediterranean Plant Protection Organization. 35 (3): 436–438. 2005. doi:10.1111/j.1365-2338.2005.00844.x.
^ Jump up to: a b Miller, Matthew. "Battle of the Ash Borer: Decades after Beetles Arrived in Michigan, Researchers Looking to Slow Devastation". Lansing State Journal.
Jump up ^ Parsons, Gary L. (November 2008). "Emerald ash borer: A guide to identification and comparison to similar species" (PDF). USDA. Retrieved August 15, 2014.
Jump up ^ "Native Borers and Emerald Ash Borer Look-alikes" (PDF). Michigan State University Extension. Retrieved 12 March 2017.
^ Jump up to: a b c d Gould, Juli S.; Bauer, Leah S.; Lelito, Jonathan; Duan, Jian (May 2013). "Emerald Ash Borer Biological Control Release and Recovery Guidelines" (PDF). USDA-APHIS-ARS-FS.
^ Jump up to: a b c d e f g h i j k l m n o p q r s t Herms, Daniel A.; McCullough, Deborah G. (October 2013). "Emerald Ash Borer Invasion of North America: History, Biology, Ecology, Impacts, and Management" (PDF). Annual Review of Entomology. 59: 13–30. doi:10.1146/annurev-ento-011613-162051. PMID 24112110.
^ Jump up to: a b c d e f g h Poland, Therese. M; Chen, Tigen; Jennifer, Koch; Pureswaran, Deepa (December 2014). "Review of the emerald ash borer (Coleoptera: Buprestidae), life history, mating behaviours, host plant selection, and host resistance" (PDF). The Canadian Entomologist. 147: 252–262. doi:10.4039/tce.2015.4.
^ Jump up to: a b c d e f g h i j k Valenta, V.; et al. (2016). "A new forest pest in Europe: a review of Emerald ash borer(Agrilus planipennis) invasion". Journal of Applied Entomology. doi:10.1111/jen.12369.
Jump up ^ "Agrilus planipennis (insect)". Global Invasive Species Database. ISSG-IUCN. August 14, 2006.
^ Jump up to: a b "Emerald ash borer". USDA Forest Service. Retrieved July 5, 2015.
Jump up ^ Peter A. Thomas (2016). "Biological Flora of the British Isles: Fraxinus excelsior". Journal of Ecology. 104: 1158–1209. doi:10.1111/1365-2745.12566.
Jump up ^ "Ash tree set for extinction in Europe". BBC. 23 March 2016. Retrieved 23 March 2016.
Jump up ^ Wang, Xiao-Yi; et al. (2010). "The biology and ecology of the emerald ash borer, Agrilus planipennis, in China". Journal of Insect Science. 10: 128.
Jump up ^ Poland, T.; McCullough, D. (2006). "Emerald ash borer: invasion of the urban forest and the threat to North America's ash resource" (PDF). Journal of Forestry. 104: 118–124.
Jump up ^ "Emerald Ash Borer attacking White Fringe Tree". Retrieved 14 December 2014.
Jump up ^ "Agrilus planipennis (insect)". Global Invasive Species Database. ISSG-IUCN. August 14, 2006. Retrieved August 28, 2013.
^ Jump up to: a b c "Initial County EAB detections in North America" (PDF). USDA. Retrieved 28 January 2017.
Jump up ^ Cappaert, D.; et al. (Fall 2005). "Emerald ash borer in North America: a research and regulatory challenge". American Entomologist. 51: 152–163. doi:10.1093/ae/51.3.152.
Jump up ^ Lui, Houping; et al. (2003). "Exploratory survey for the emerald ash borer, Agrilus planipennis (Coleoptera: Buprestidae), and its natural enemies in China" (PDF). Great Lakes Entomologist. 36: 191–204. Retrieved 28 May 2014.
Jump up ^ Rebek, E. J.; Herms, D. A.; Smitley, D. R.; et al. (2013). "Interspecific Variation in Resistance to Emerald Ash Borer (Coleoptera: Buprestidae) Among North American and Asian Ash (Fraxinus spp.)" (PDF). Environmental Entomology. 37 (1): 242–246. doi:10.1603/0046-225X(2008)37[242:IVIRTE]2.0.CO;2. PMID 18348816.
Jump up ^ Anulewicz, Andrea C.; McCullough, Deborah G.; Cappaert, David L. (September 2007). "Emerald Ash Borer (Agrilus planipennis) Density and Canopy Dieback in Three North American Ash Species". Aboriculture & Urban Forestry. International Society of Arboriculture. 33 (5): 338–349. doi:10.1007/s10530-013-0543-7.
Jump up ^ DeSantis, Ryan D.; et al. (April 21, 2013). "Effects of climate on emerald ash borer mortality and the potential for ash survival in North America". Agricultural and Forest Meteorology. 178: 120.
Jump up ^ "The Upside Of The Bitter Cold: It Kills Bugs That Kill Trees". National Public Radio. Retrieved May 21, 2014.
^ Jump up to: a b McCullough, D.G.; et al. (2012). "Evaluation of potential strategies to SLow Ash Mortality (SLAM) caused by emerald ash borer (Agrilus planipennis): SLAM in an urban forest" (PDF). International Journal of Pest Management. 58: 9–23. doi:10.1080/09670874.2011.637138.
Jump up ^ Kovacs, K. F.; et al. (September 2009). "Cost of potential emerald ash borer damage in U.S. communities, 2009-2019" (PDF). Ecological Economics. 69 (3): 569–578. doi:10.1016/j.ecolecon.2009.09.004.
Jump up ^ "Emerald Ash Borer (EAB) is in Minneapolis". Minneapolis Park and Recreation Board. Retrieved August 29, 2013.
Jump up ^ Careless, Philip; Marshall, Stephen. A.; Gill, Bruce D.; et al. (February 2014). "The use of Cerceris fumipennis (Hymenoptera: Crabronidae) for surveying and monitoring emerald ash borer (Coleoptera: Buprestidae) infestations in eastern North America". Canadian Entomologist. 146: 90–105. doi:10.4039/tce.2013.53.
Jump up ^ "Moving Firewood". USDA. Retrieved 28 January 2017.
Jump up ^ "Ash replacement information". USDA Forest Service. Retrieved July 15, 2014.
Jump up ^ "SLAM: SLow Ash Mortality".
Jump up ^ "After Your Ash Has Died: Making an Informed Decision on What to Replant" (PDF). extension.ca.uky.edu.
^ Jump up to: a b Herms, Daniel A.; McCullough, Deborah G.; Smitley, David R.; Sadof, Clifford S.; Williamson, R. Chris; Nixon, Phillip L. (June 2009), "Insecticide Options for Protecting Ash Trees from Emerald Ash Borer" (PDF), North Central IPM Center Bulletin, North Central IPM Center: 12, retrieved August 30, 2013
Jump up ^ Hahn, Jeffrey; Herms, Daniel A.; McCullough, Deborah G. (February 2011), Frequently Asked Questions Regarding Potential Side Effects of Systemic Insecticides Used to Control Emerald Ash Borer (PDF), www.emeraldashborer.info, retrieved August 30, 2013
Jump up ^ Doccola, Joseph J.; Smitley, David R.; Davis, Terrance W.; Aiken, John J.; Wild, Peter M. (January 2011). "Tree Wound Responses Following Systemic Insecticide Trunk Injection Treatments in Green Ash (Fraxinus pennsylvanica Marsh.) as Determined by Destructive Autopsy". Aboriculture & Urban Forestry. International Society of Arboriculture. 37 (1): 6–12.
Jump up ^ Bauer, L.S.; Liu, H-P; Miller, D.; Gould, J. (2008). "Developing a classical biological control program for Agrilus planipennis (Coleoptera: Buprestidae), an invasive ash pest in North America" (PDF). Newsletter of the Michigan Entomological Society. 53 (3&4): 38–39.
Jump up ^ "Biological Control of the Emerald Ash Borer". United States Department of Agriculture Forest Service.
^ Jump up to: a b c Bauer, Leah S.; Duan, Jian J.; Gould, Juli R.; van Driesche, Roy; et al. (March 8, 2015). "Progress in the classical biological control of Agrilus planipennis Fairmaire (Coleoptera:Bupresitdae) in North America". The Canadian Entomologist. 147: 300–317. doi:10.4039/tce.2015.18.
Jump up ^ "Biocontrol: Fungus and Wasps Released to Control Emerald Ash Borer". Science News. Science Daily. May 2, 2011. Retrieved August 30, 2013.
External links[edit]
Wikimedia Commons has media related to Emerald ash borer.
Wikispecies has information related to Agrilus planipennis
Interview with researcher
Canadian Food Inspection Agency
USDA Forest Service Northern Research Station link to research on EAB
Ohio Department of Agriculture infestation PDF map
Species Profile- Emerald Ash Borer (Agrilus planipennis), National Invasive Species Information Center, United States National Agricultural Library. Lists general information and resources for Emerald Ash Borer.
The short film Emerald Ash Borer: The Green Menace is available for free download at the Internet Archive
Retrieved from "https://en.wikipedia.org/w/index.php?title=Emerald_ash_borer&oldid=818482142"
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Quality by Design
From Wikipedia, the free encyclopedia
Jump to: navigation, search
Quality by Design (QbD) is a concept first outlined by quality expert Joseph M. Juran in publications, most notably Juran on Quality by Design.[1] Designing for quality and innovation is one of the three universal processes of the Juran Trilogy, in which Juran describes what is required to achieve breakthroughs in new products, services, and processes.[2] Juran believed that quality could be planned, and that most quality crises and problems relate to the way in which quality was planned.
While Quality by Design principles have been used to advance product and process quality in industry, and particularly the automotive industry, they have also been adopted by the U.S. Food and Drug Administration (FDA) for the discovery, development, and manufacture of drugs.[3][4][5][6]
Contents
[hide]
1 Juran on Quality by Design
1.1 Integrated planning
1.2 Customer-focused optimization
1.3 Control over variation and transfer to operations
2 Pharmaceutical Quality by Design (QbD)
2.1 QbD activities within FDA
2.2 ICH activities
3 See also
4 Additional Reading
5 References
6 External links
Juran on Quality by Design[edit]
The Juran Trilogy[2] defines the word "quality" as having two meanings: first, the presence of features that create customer satisfaction; second, the reliability of those features. Failures in features create dissatisfactions, so removing failures is the purpose of quality improvement, while creating features is the purpose of quality by design.[7] Juran's process seeks to create features in response to understanding customer needs. These are customer-driven features. The sum of all features is the new product, service, or process.[8]
The Quality by Design model consists of the following steps:
Establish the project design targets and goals.
Define the market and customers that will be targeted.
Discover the market, customers, and societal needs.
Develop the features of the new design that will meet the needs.
Develop or redevelop the processes to produce the features.
Develop process controls to be able to transfer the new designs to operations.[7]
It is not a statistical design method like Design for Six Sigma.
Integrated planning[edit]
Integrated planning requires a team with a leader whose sole accountability is for the total success of the new product from defining the opportunity through customer purchase, use, service, and recommendation to others. This team leader reports directly to a senior executive, or the team leader can be a senior executive. Each team member's job is to ensure the success of the new product.[9]
In addition to organizational integration, a successful team must begin with clearly articulated common goals for the product that are measurable and authorized by the enterprise. These goals must, at a minimum, cover such elements as:
The customers or customer segments to be served by the new product
The relative and absolute quality goals
The volume of sales or revenue to be generated in an initial time period and for the long run
Market share, penetration, or sales relative to key competitors
The release date
The team will follow a structured process. The structure is the common framework for all participants in launching the new product and helps ensure success.[9]
Customer-focused optimization[edit]
Quality by Design starts and ends with the customer.[1] Every new product introduction has some amount of trade-off involved. If there are multiple customers, they may have conflicting needs. Even the same customer may have needs that compete with each other. Capacity and speed compete with cost of operation. Capacity can compete with speed. Flexibility and feature-rich offerings may have reduced ease of use, and so on.[7]
Quality by design offers a range of tools and methods intended to make these tradeoffs explicit and optimal for the customer. Some tools are highly mathematical, and others relate more to customer behavior. Quality by Design sets strong expectations for creative approaches to functional design, product features and goals, and production design.[10]
Control over variation and transfer to operations[edit]
Quality by design incorporates modern tools to preemptively control variation. These tools and methods begin by measuring and understanding the variation that exists by using historical data, testing, and modeling to help forecast, analyze, and eliminate the deleterious effects of variation using standard statistical techniques.[10] Process control consists of three basic activities:
Evaluate the actual performance of the process
Compare actual performance with goals
Take action on the difference [7]
The final activity of the quality by design process is to implement the plan and validate that the transfer has occurred.[7]
Pharmaceutical Quality by Design (QbD)[edit]
The FDA imperative is outlined in its report "Pharmaceutical Quality for the 21st Century: A Risk-Based Approach."[11] In the past few years, the agency has implemented the concepts of QbD into its pre-market processes. The focus of this concept is that quality should be built into a product with an understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks. This is a successor to the "quality by QC" (or "quality after design") approach that the companies have taken up until the 1990s.[12]
The QbD initiative, which originated from the Office of Biotechnology Products (OBP), attempts to provide guidance on pharmaceutical development to facilitate design of products and processes that maximizes the product's efficacy and safety profile while enhancing product manufacturability.
QbD activities within FDA[edit]
The following activities are guiding the implementation of QbD:
In FDA's Office of New Drug Quality Assessment (ONDQA), a new risk-based pharmaceutical quality assessment system (PQAS) was established based on the application of product and process understanding.
Implementation of a pilot program to allow manufacturers in the pharmaceutical industry to submit information for a new drug application demonstrating use of QbD principles, product knowledge, and process understanding. In 2006, Merck & Co.'s Januvia became the first product approved based upon such an application.[13]
Implementation of a Question-based Review (QbR) Process has occurred in CDER's Office of Generic Drugs.
CDER's Office of Compliance has played a role in complementing the QbD initiative by optimizing pre-approval inspection processes to evaluate commercial process feasibility and determining if a state of process control is maintained throughout the lifecycle, in accord with the ICH Q10 lifecycle Quality System.
First QbD Approval - including design space - for Biologic License Application (BLA) is Gazyva (Roche) [14]
While QbD will provide better design predictions, there is also a recognition that industrial scale-up and commercial manufacturing experience provides knowledge about the process and the raw materials used therein. FDA's release of the Process Validation[12] guidance in January 2011 notes the need for companies to continue benefiting from knowledge gained, and continually improve throughout the process lifecycle by making adaptations to assure root causes of manufacturing problems are corrected.
On the other hand, - the premise that the current iteration of QbD places too much emphasis on mathematical algorithmic Design of Experiment (DoE) models unsuitable for application to complex, multifactorial, non-stochastic pharmaceutical processes has been advanced.[15]
ICH activities[edit]
Working with regulators in the European Union (the European Medicines Agency) and Japan, the FDA has furthered Quality by Design objectives through the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH guidelines Q8 (on Pharmaceutical Development), Q9 (on Quality Risk Management), and Q10 (on Pharmaceutical Quality System) provide some assistance for manufacturers to implement Quality by Design into their own operations.[16] The ICH Steering Committee meets twice a year to discuss the progress of its efforts. This practical input should help ensure that quality risk management and knowledge management are used to make lifecycle adaptations that maintain process control and product quality.
See also[edit]
Laboratory quality control
Quality control
International Society for Quality Electronic Design
Additional Reading[edit]
Joseph M. Juran, a perspective on past contributions and future impact, Quality and Reliability Engineering International, Vol. 23, pp. 653–663, 2007 by Godfrey, A.B. and Kenett, R.S.
Quality by Design Applications in Biosimilar Technological Products, ACQUAL, Accreditation and Quality Assurance, Springer Verlag, Vol. 13, No 12, pp. 681–690, 2008 by Kenett R.S. and Kenett D.A.
References[edit]
^ Jump up to: a b Juran, J.M. (1992). Juran on Quality by Design: The New Steps for Planning Quality into Goods and Services. Free Press.
^ Jump up to: a b Juran, J.M. (1986). "The Quality Trilogy: A Universal Approach to Managing for Quality". Quality Progress.
Jump up ^ Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control
Jump up ^ Roadmap for implementation of quality by design (QbD) for biotechnology products
Jump up ^ Development of a new predictive modelling technique to find with confidence equivalence zone and design space of chromatographic analytical methods
Jump up ^ Schweitzer, Mark; et al. (February 2010). "Implications and Opportunities of Applying QbD Principles to Analytical Measurements". Pharmaceutical Technology. 34 (2): 52–59.
^ Jump up to: a b c d e DeFeo, Joseph A. & Juran, Joseph M. (2010). Juran's Quality Handbook: The Complete Guide to Performance Excellence 6/e. McGraw Hill.
Jump up ^ DeFeo, Joseph A. (2014). Juran's Quality Essentials for Leaders. McGraw Hill.
^ Jump up to: a b Early, John (14 Feb 2013). "Quality by Design, Part 1". Quality Digest.
^ Jump up to: a b Early, John (19 Feb 2013). "Quality by Design, Part 2". Quality Digest.
Jump up ^ Pharmaceutical Quality for the 21st Century: A Risk-Based Approach http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm128080.htm
^ Jump up to: a b "Process Validation: General Principles and Practices" (PDF). FDA Guidance.
Jump up ^ FDA Approves New Treatment for Diabetes 17 Oct 2006.
Jump up ^ http://qbdworks.com/qbd-biologics-gazyva-design-space/
Jump up ^ http://ojs.abo.fi/index.php/jefc/article/view/98/91
Jump up ^ ICH Quality Guidelines
External links[edit]
Implementing Quality by Design, by Helen Winkle, FDA
Implementation of QbD Principles in CMC Review, by Chi-Wan Chen, PhD, Deputy Director, Office of New Drug Chemistry
Quality-by-Design Case Studies in Pharmaceuticals and Biologics
Juran.com
Retrieved from "https://en.wikipedia.org/w/index.php?title=Quality_by_Design&oldid=759311441"
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This page was last edited on 10 January 2017, at 12:37.
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