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Terminology
Who's Who?
Products
cGMP
Departments
100
Initiated by site services at 76400 for safety and site maintenance needs.
What is a Work Order?
100
This man was a French chemist and microbiologist renowned for his discoveries in the principles of vaccination, microbial fermentation and pasteurization
Who is Louis Pasteur?
100
Name our Vaccine that prevents Haemophilus Influenzae B
What is ActHIB?
100
Name 3 industries the FDA is responsible for regulating.
What is: 1)Food Safety 2)Tobacco Products 3)Dietary Supplements 4)Prescription/OTC Pharmaceuticals 5)Vaccines 6)Biopharmaceuticals 7)Blood Transfusions 8)Medical Devices 9)Electromagnetic Radiation emitting devices 10)Cosmetics 11)Animal Food 12)Veterinary Products
100
_____ ______is the department that ensures a batch has been manufactured and checked in accordance with the requirements of its marketing authorization, the principles and guidelines of Good Manufacturing Practice
What is Batch Release?
200
These are used to control airflow within the sterile manufacturing environment, they are used to separate different Grade areas.
What is an Airlock?
200
This man Founded the “Pocono Biological Laboratories”, which now houses the U.S. headquarters of Sanofi Pasteur.
Who is Richard Slee?
200
Name 1 out of the 2 vaccines we manufacture that include:Tetanus & Diphtheria Toxoids as well as Acellular Pertussis in one product.
What is Daptacel/Adacel?
200
A ______ is issued to senior management at the conclusion of an inspection when an investigator(s) has observed any conditions, that in their judgement, may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts
What is the FDA Form 483 (Warning)?
200
This department is responsible for buying components, raw materials, office supplies, anything related to our operations which we require
What is Purchasing?
300
Certain bacteria have a polysaccharide outer coat that are poorly immunogenic. By linking these outer coats to proteins (e.g., toxins), the immune system can be led to recognize the polysaccharide as if it were a protein antigen. What is the term for this process?
What is Conjugation/Conjugate?
300
This Senior Director was newly appointed as M.Tech head, replacing Kumar Namdev.
Who is Kristine Marchant?
300
What is the name of our product(s) that prevents/treats patients exposed to rabies?
What is ImovaxRabies Vaccine/ImogamRabies -HT?
300
The CFR is divided into 50 titles that represent broad subject areas: What title does Sanofi Pasteur deal with directly?
What is Title 21 (i.e. 21 CFR ...)?
300
This department oversee's and approves all traffic and gowning procedure, as well as ensuring a clean manufacturing environment
What is Sterility Assurance?
400
This is a planned change in the manufacturing process, to increase the efficiency or safety/quality of the product.
What is Change Control?
400
This Senior director is head of Materials/Supplier Management
Who is Joseph Giamber?
400
What vaccine do we manufacture that strictly prevents meningitis only?
What is Menomune?
400
If a company is not complying with CGMP regulations, any drug it makes is considered _______ under the law
What is Adulterated?
400
This department is responsible for submitting Documentation for the Manufacturing of and Controls for Drug Products, labeling, and acts as a liason between our organization and our applicable agencies.
What are Regulatory Affairs?
500
______ are added to promote an earlier, more potent response, and more persistent immune response to the vaccine; they allow for a lower vaccine dosage.
What are Adjuvants?
500
This Senior Director is head of GEM(Global Engineering & Maintenance)
Who is Kenneth Solomon?
500
What is the market/street name of our C.Diff vaccine?
What is C.Diffense?
500
Which of these regulatory actions are not part of the FDA's direct responsibility with regard to violations in cGMP A)Seizure of Product B)General Public Warning C)Enforce a Product Recall D)File an Injunction Case
C)Enforce a Product Recall While FDA cannot force a company to recall a drug, companies usually will recall voluntarily or at FDA’s request. If a company refuses to recall a drug, FDA can warn the public and can seize the drug.
500
A System level Impact Assessment (SLIA) is used in facilities, utilities and equipment. It determines impact on product safety, identity, strength, purity, efficacy, and/or quality. What department approves this?
What are Quality Projects, Qualification & Validation(QPQV)?