qc

• It was in this year when Marshall became dean of WMCP

  1887-1917
• it is the application of procedures of quantitative analytical chemistry


  Quantitative Pharmaceutical Chemistry
• WHO defines this a part of firm's process concerned with medicine sampling, specifications, testing and the organization release procedures that ensures that the necessary tests are carried out and that the materials are not released for use, nor products released for sale or supply, until their product has been judged satis

  factory.

  Pharmaceutical Quality Control
• Quality control guarantees include the following:


  Drug is free from impurities, physically and chemically stable, Contains amount of API stated on the label, provides optimal release of active ingredients when the product is administered.
• It is a combination of two compendia

  USP-NF.
• Monographs for drug substances, dosage forms, and compounded preparations are featured in?

  USP
• Excipient monographs are in?

  NF
• A monograph includes:


  Name of ingredient, definition, packaging, storage, labeling requirements, and the specification.
• It consists of a series of test, procedures for the tests, and acceptance criteria.

  The Specification
• The tests and procedures in the specifications require the use of?

  USP Reference Standards
• An independent , scientific, and non profit organization dedicated to improving public health.

  United States Pharmacopoeia
• it was in this year when a group of physician came together to protect patients by forming USP.

  1820
• It was in this year when USP published the 1st edition of a national, uniform set of guidelines.

  1820
• In this year, and what legislation that recognized USP standards for strength and purity, arming inspectors at ports of entry with tools to identify drugs that were substandard or deliberately adulterated.

  1848, Drug Importation Act
• In this year, doctors were desperate to look for an accurate source of information about medicines. They knew that they could trust the information about medicinal substance and their preparation that the usp provided.

  1863
• She was appointed as the first woman member of the U.S Pharmacopoeial Convention


  Clara Marshall, M.D.
• Clara Marshall was born on and died in?

  1848-1931
• Marshall became the first female student in Philadephia College of Pharmacy in what year?


  1876
• Clara Marshall earned her medical degree at Women's Medical College of Pennsylvania in what year?


  1875
• Clara marshall became the dean of WMCP from what range of year?

  1887-1917
• Year when A woman's place is at USP

  1880
• Diptheria antitoxin tragedy shines a spotlight on medicine quality in what year?


  1905
• In what year did 13 children died due to diptheria antitoxin contaminated wt tetanus?


  1901
• This year when USP introduced public standard for diptheria antitoxin

  1905
• In what year a federal mandate to ensure strength, quality and purity of medicines exist?

  1906
• This passage recognized USP standards as official for strength, quality and purity.

  Pure Food and Drug Act of 1906
• in this year, drug marketed in the U.S were legally required to meet usp standards.

  1906
• Because people everywhere should have access to quality medicines existed in what year?

  1908
• It was in this year when USP was translated and made accessible to other countries around the world.

  1908
• USP offers physical reference standards for testing medicine quality in what year?

  1932
• USP begins its Reference Standards Program, offering physical specimens of drugs tested according to USP guidelines so manufacturers can test their products to ensure they meet specifications in what year?


  1932
• It is a fruit-flavored liquid antibiotic that killed over 100 people in the U.S

  Elixir Sulfanilamide
• USP standards are required by law after untested medicines killed over 100 people in what range of year?


  1937-1938
• In elixir sulfanilamide, the manufacturer had only tested what?

  Appearance and palatability
• In this range of years, congress respond with legislation that required companies to test all new drugs to verify that they meet USP standards for identity, strength, quality, and purity, and submit the data to the FDA before marketing.

  1937-1938
• A frantic race to keep lifesaving insulin available to patients happened in what year?

  1941
• Insulin was first used to treat diabetes in what year?


  1922
• In 1941, when the patent on insulin was about to expire, there was no public standard available. True or False?


  True
• In this year when USP developed a standard for insulin

  1941
• USP responds to critical wartime needs for medicines existed in year?

  1944