What was developed after a series of manufacturing mishaps in the 60's and 70's?

Which congressional act recognized USP?

The FDA (Food and Drug Administration) is an agency within the Department of Health and Human Services and consists of nine centers/offices.

"Thalidomide, a sedative marketed to combat morning sickness, caused birth defects in thousands of babies born in Western Europe"

The FDA's portion of the CFR is Title 21 of CFR.

Which conflict brought regulation to US importation of drugs?

Weekly quizzes will be posted by Friday and due Mondays by 11:59pm.

Each homework should be submitted two ways in Blackboard- the Turn It In Submission and the Blackboard Submission.

Which of the following is not a branch of the FDA?

"The CFR is in place to ensure identity, strength, quality and taste of drug products. Failure to comply renders the drug as adulterated and the firm could be subject to regulatory action. "

"Samuel Hopkin Adams, Upton Sinclair, Harvey W. Wiley, M.D were the prominent muckrakers. "

"If there is a conflict between regulations, the less specific regulation applicable to the product will supersede the more general"

What is not a benefit of cGMPS?

Quinine was used to treat:

"Nearly 500 deaths and injuries from sulfathiazole tablets, an antibiotic, tainted with the sedative, phenobarbital. "

What company does Ashley work for?

What did the Biologics Control Act of 1902 did not require the federal government to issue pre-market approval for biological drugs.

What is subpart F of Title 21 CFR Part 211?

In 1963 the first set of GMPs were published: A drug shall be deemed unadulterated if the methods used in, or the facilities or controls used for its manufacture, processing, packing, or holding, do not conform with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety, and has the identity and strength, and meets the quality and purity characteristics, which it purport to possess. 

What does CFR stand for?

Kefauver-Harris Amendments of 1962

The Elixir Sulfanilamide crisis of 1937 contained a solvent in the drug that was a highly toxic variant of _________.

Samuel Hopkins Adams wrote "The Jungle" exposing the meat industry in 1906. 

The FDA only regulates food, drugs, biologics and medical devices. 

"_________________ means a finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally in association with inactive ingredients."

What does cGMP stand for?

The Biologics Control Act of 1902 required federal government to issue pre-market approval for biological drugs.

"_____ is the drug product component that is intended to furnish pharmacological property or other direct effect in diagnosis, cure, mitigation, treatment, or preventation of disease. "

Thalidomide, a sedative marketed to combat morning sickness, caused birth defects in thousands of babies born in Western Europe.

"FDA stands for ________________________ and started out as BOC, which stands for _________________ and was under the US Department of Agriculture."

What does API stand for?

The crisis of a sedative in antibiotic caused nearly 300 deaths and injuries from sulfathiazole tablets, an antibiotic, tainted with the sedative, phenobarbital. A major cause of this was the tableting machines of two different products were in the same room.

"Required all medications entering U.S. to be inspected by the US Customs Service and analyzed for ""quality, purity, and fitness for medical purposes.”"

"cGMP regulations for finished pharmaceuticals are covered in CFR title _____, Parts ____ and _____. "

Which of the following is not one of the eight centers or offices of the FDA?

The Pure Food and Drugs Act 1906 (Wiley Act)

"1.      The regulations set forth in CFR21 parts 210 and 211 contain the minimum current good manufacturing practices for any buildings or facilities used in the m____________, p_____________, p______________, or h_______________ of a drug product to assure that such drug meets the requirements of the FFDCA. (2 pts)"

"Under plumbing regulations in a cGMP facility, water supply must be under positive pressure and must at least meet ____________ drinking water standards."

"Nexus Pharmaceuticals in Pleasant Prairie, Wisconsin is a packaging center for products indicated for the treatment of bleeding disorders."

"Sterile filling rooms for certain types of drugs, like intravenous and ophthalmic formulations, would usually have what kind of doors?"

"A _______ is a layout showing material flow, personnel movement, the order of processes, storage and staging areas for materials in a manufacturing. "

Adequate and appropriate lighting is recommended in a cGMP facility because it is an FDA guideline.

One cGMP requirement for equipment is that they should be constructed of material that is __________________ with the drug components. The most common material type to meet that requirement is _____________________.

Describe one cGMP requirement for aseptic processes

"One cGMP regulation states that buildings and facilities should have adequate lighting, plumbing and HVAC. What does HVAC stand for?"

What is Rudy Herrera's title from this week's videos posted in Blackboard?

"In a New Drug Application, the ____________________________ (SMF) serves to demonstrate a company’s compliance with GMP and gives a general overview about the facility and it’s operations."

"Of two types of hood normally found in a drug manufacturing facility, one type is designed to protect ____________ and the other is designed to protect _____________."

Describe two examples of controls that are put into place to assure consistently reliable operation of equipment.

Describe one feature of floors in cGMP-complaint facilities

"As a cGMP requirement for aseptic processes, what 2 climate components are controlled to discourage microbial growth and maintain product stability?"

What two general categories of “stuff” do companies test for when they perform environmental monitoring?

The air that is recirculated in a facility for aseptic processes are HEPA filtered. What does HEPA stand for?

"On regulations on the proper segregation of space to minimize product contamination, the antibiotic, _______________, shall be handled in facilities separate from those used for other human drugs."

"After a drug product is released for distribution into the marketplace, reserve materials are retained by the manufacturer. Describe one cGMP requirement for the reserve materials."

"USP provides standardized tests, or SOPs, for physicial characteristics of containers and closures, including tests for heavy metals and other residues, that may affect the quality of the drug product. What does USP stand for? "

"Tests to determine conformance to specifications prior to release of each batch includes only raw materials, in-process materials and drug products."

"For the control of cut labels, if applied manually, describe how the labels should be inspected. "

"After receiving and confirming the identification of delivered components, containers or closures, the materials are assigned to QC analysts within how many days upon arrival?"

"Under QC sampling procedures, there needs to be at least one test conducted on components received for conformity to specifications and to confirm results of tests provided by a material supplier in the CofA. What does C of A stand for?"

Pressure/vacuum decay and dye penetration tests are some advantages to testing the integrity of containers and closure systems. What is not an advantage of those alternative tests to that of directly testing for microbial contamination.

Two types of closures of drug products are _____ and ______.

Two types of containers of drug products are _____ and _______.

The expiration date on a drug product is based on __________ data.

"For the control of containers, closures, packages and labels, there must be procedures written and followed on the release, id, storage and handling. "

Which company is in the Quality Control Laboratories Help Ensure High Quality Medicines video?

"As a result of cyanide poisoning of children's Tylenol in the 1980s, over-the-counter drugs are now required to have _______ package or design. "

CFR 21 Part 211 subpart G is about:

A device that serves to seal a container is referred to as a ________.

"A component is any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product."

What type of facility does the Lonza Career video mention?

_________ means printing labels for more than one drug product on one sheet of material.

Inspection of a packaging equipment to ensure that nothing remains from an earlier processed batch is referred to as _______

What type of stem cell is mentioned in the Hope Biosciences video?

A second person is not allowed to document another person's work unless they are designated and trained to do so.

If you make a mistake in entering data in a table, you should erase it with White-Out or Liquid paper, write the correct entry on top of the White-out, and initial and date the correction.

There are normally 3 signatures found on the cover page of an executed batch record. Who are the 2 of the signatories?

Under Records and Reports GMPs, the importance of documentation is highlighted in the Expression, If it's not recorded, then it ___________________________.

An __________ is an amount of material in excess of what would normally be used up by a process, allocated for reasons like a huge amount of materials that may be needed for all the control tests.

To make a correction, draw a single line through any mistakes, intial and date the correction. Include a reason for the correction at the bottom of the page.

In one of the videos where does Dean work?

Two types of information which are required in labels of containers of dispensed materials are weighed by and checked by.

In addition to the cover page, list 2 types of information that are included as part of Master Batch Records.

Executed batch records are documentation to demonstrate that the batch was made according to the approved procedures as outlined in the MBR. The EBR is reviewed by

Written production and process control procedures shall be followed and shall be _________________________.

In the Advil tablet manufacturing video, how many checks are conducted in different steps in the tableting process to monitor and obtain consistent quality of the drug product?

Rejected in-process materials shall be identified and controlled under a _____ system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.

What is the apparatus or piece of equipment that is used to take small amounts of in-process material for testing from an equipment like a V-Blender?

All records are to be retained (and available for review by an investigator) until at least 3 years after the expiration date of the batch of drug.

The last step of the process flow for solid dosage form is:

A diagram contains all the information a trained operator needs to make the product the same way every time with the goal of achieving batch to batch quality.

What does OOS stand for?

A Class _____ recall is issued whenever a defective product could cause serious health problems or death.

Calculation of yields should be performed by one person and verified by another person.

ANSI stands for American New Standards Institute.

"In equipment logs, aside from cleaning and maintenance activities, what is the 3rd type of activity that is normally recorded?"

A master batch record must include the actual yields.

A product that was subjected to improper storage condition can still be salvaged if there is evidence from inspection of the affected premises that the drug products were in fact not subjected to improper stroage conditions as a result of a disaster.

"Physical controls of a facility does not include hair nets, gloves, tyvek suits, filtered supply air to work areas"

"After a batch of drug had been produced, a batch that does not meet acceptance criteria maybe rejected outright or placed in ______ pending final disposition by the ______ group, or determination that it maybe reprocessed."

"Production, control, or distribution records, associated with a batch, shall be retained for at least _______ year after the batch expiration, and ________ years after distribution for OTC."

CAPA stands for?

"Actual yield means the quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular drug product. "

AQL stands for Acceptable Quality Limit

"In a laboratory notebook page, an FDA auditor would expect to see the signature of the researcher who performed the experiment, and the signature of a second person who reviewed the accuracy and completeness of data entered."

" _________ logs, that show the amount of starting materials, and details of where the material went, are required to provide traceability of Components, Drug Product Containers & Closures, and Labels."

Laboratory records must include ____ data from all tests done to ensure compliance.

One acceptable occurrence that can lead to reprocessing is not labels that are smeared and illegible.

A higher than expected yield is always a good thing.