API production and quality assurance interview questions

GOOD MANUFACTURING PRACTICES (GMP) : Good manufacturing practice  (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

WHAT IS EMULSION : An  emulsion  is a  mixture  of two or more  liquids  that are normally  immiscible  (unmixable or unblendable). Emulsions are part of a more general class of two-phase systems of  matter  called  colloids . Although the terms  colloid  and  emulsion  are sometimes used interchangeably,  emulsion  should be used when both phases, dispersed and continuous, are liquids. In an emulsion, one liquid (the dispersed  phase ) is  dispersed  in the other (the continuous phase). Examples of emulsions include  vinaigrettes , homogenized  milk , and some  cutting fluids  for  metal working . Two liquids can form different types of emulsions. As an example, oil and water can form, first, an oil-in-water emulsion, in which the oil is the dispersed phase, and water is the continuous phase. ( Lipoproteins , used by all complex living organisms, are one e...

THEORITICAL YIELD VS ACTUAL YIELD : Amounts of products calculated from the complete reaction of the limiting reagent are called  theoretical yields , whereas the amount actually produced of a product is the  actual yield . The ratio of  actual yield  to  theoretical yield  expressed in percentage is called the percentage  yield

WHAT IS CATALYST,LIST OF COMMONLY USED CATALYST IN REACTIONS : A  catalyst  is a substance that can be added to a  reaction  to increase the  reaction  rate without getting consumed in the process.  Catalysts  typically speed up a  reaction  by reducing the activation energy or changing the  reaction  mechanism. Enzymes are proteins that act as  catalysts  in biochemical  reactions. COMMONLY USED CATALYST IN REACTIONS: process catalyst ammonia synthesis iron sulfuric acid manufacture nitrogen(II) oxide, platinum cracking of petroleum zeolites hydrogenation of unsaturated hydrocarbons nickel, platinum, or palladium

MATERIAL HOIST OPERATION :

SHORT TERM EXPOSURE LIMIT  :  short-term exposure limit  ( STEL ) is the acceptable average exposure over a short period of time, usually 15 minutes as long as the time-weighted average is not exceeded.

 THRESHOLD LIMIT VALUE : The  threshold limit value  ( TLV ) of a  chemical substance  is believed to be a level to which a worker can be exposed day after day for a working lifetime without  adverse effects . Strictly speaking, TLV is a reserved term of the  American Conference of Governmental Industrial Hygienists  (ACGIH). TLVs issued by the ACGIH are the most widely accepted occupational exposure limits both in the United States and most other countries. [1

FLASHPOINT : The  flash point  of a  volatile  material is the lowest  temperature  at which its vapours  ignite  if given an ignition source. The flash point is sometimes confused with the  autoignition temperature , the temperature that causes spontaneous ignition. The  fire point  is the lowest temperature at which the vapors keep burning after the ignition source is removed. It is higher than the flash point, because at the flash point more vapor may not be produced fast enough to sustain combustion. [1]  Neither flash point nor fire point depends

CHEMICAL COMPATABILITY CHART : Chemical compatibility  is a measure of how stable a  substance  is when mixed with another substance. [1]  If two substances can mix together and undergo a  chemical reaction , they are considered incompatible. Chemical compatibility is important when choosing materials for chemical storage or reactions, so that the vessel and other apparatus will not be damaged by its contents. For purposes of  chemical storage , chemicals that are incompatible should not be stored together so that any leak will not cause an even more dangerous situation by reacting after leaking. In addition, chemical compatibility refers to the container material being acceptable to store the chemical or for a tool or object that comes in contact with a chemical to not degrade. For example, when stirring a chemical the stirrer must be stable in the chemical that is being stirred. Because of this many companies publish  chemical resistance ...

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