API production and quality assurance interview questions

fda warning letters : How serious is an FDA warning letter? A Warning Letter is informal and advisory. It communicates the agency's position on a matter, but it does not commit FDA to taking enforcement action. For these reasons,  FDA does not consider Warning Letters to be final agency action on which it can be sued . What is the difference between FDA Form 483 and Warning Letter? An FDA 483 observation is a notice that highlights potential regulatory problems, while a warning letter is an escalation of this notice . You need to respond in writing within 15 days of receiving both a 483 and a warning letter. What happens after a FDA warning letter? The Warning Letter  requests corrections and a written response within a specific period after receipt of the letter —usually fifteen working days. The district, at its discretion, may offer the recipient an opportunity to discuss the letter with district officials or, when appropriate, with center officials.

ENTRY AND EXIT PROCEDURE OF POWDER PROCESSING AREA : Entry and Exit Procedure in Pharmaceuticals Color coding of uniform. For first change room. For primary change room (Manufacturing, dispensing and sampling) First change room (male and female) First change room (male and female) Exit from primary change room. Exit from first change room. Precaution. For primary change room (Manufacturing, dispensing and sampling) Sky blue Lint free       –            All personal and visitors except engineering department employee Brown Lint free          –             Employees of engineering department The pictorial diagram of gowning procedure and mirror should be displayed in change room. First change room (male and female) : Pull the door of First change room. Remove your street shoes and unwanted articles li...

LIST OF API PRODUCTS HANDLED  : 1. Gabapentin - anti convulsant  2. pregabalin -  anti convulsant 3. venlafaxine hcl - anti depressant   4. bupropion hcl -  anti depressant  5. pba hcl  6. 

What is DOP (Dispersed Oil Particulate) testing : DOP, or filter integrity, testing is the process in which the integrity of your HEPA (High Efficiency Particulate Air) or ULPA (Ultra Low Penetration Air) filter is tested through the introduction of particulates. Oil is dispersed as an aerosol into the upstream flow of the filter media, while the number of particles in the downstream flow is measured using a calibrated photometer.  With cleanrooms often protecting mission critical environments, filter integrity and efficiency is vital; HEPA filters are tested to 99.99% @ 0.3 micron efficiency with ULPA filters tested to 99.9995% @ 0.12 micron. During the DOP the whole filter face is tested to ensure that any damage or leak will be detected and located. If a filter is found to fall outside of the specified efficiency standards, our engineers are trained and competent to replace the filter media quickly on site to resolve the fault, this ensures that your cleanroom down ti...

RUPTURE DISC : A  rupture disk , also known as a   pressure safety disc ,   burst disc ,   bursting disc , or   burst diaphragm , is a non-reclosing   pressure relief   safety device that, in most uses, protects a   pressure vessel , equipment or system from overpressurization or potentially damaging   vacuum   conditions. A rupture disk is a type of  sacrificial part  because it has a one-time-use membrane that fails at a predetermined differential pressure, either positive or vacuum. The membrane is usually made out of metal, [1]  but nearly any material (or different materials in layers) can be used to suit a particular application. Rupture disks provide instant response (within milliseconds or microseconds in very small sizes) to an increase or decrease in system pressure, but once the disk has ruptured it will not reseal. Major advantages of the application of rupture disks compared to using pressure relief v...

COOLING TOWER : A cooling tower removes heat from a process and rejects it to the atmosphere through the process of evaporation. In a typical application, water is pumped through a process or process machinery where it removes heat. The warm water is pumped outside to the cooling tower where it is distributed over a series of plastic sheets (fill) inside the cooling tower. An electrically powered fan moves air through the tower and causes a small portion of water to evaporate which cools the rest of the water left in the cooling tower. This process operates more efficiently and provides much cooler water temperatures than simple fan-cooled air coils. Thermal Care offers cooling towers with corrosion resistant fiberglass exteriors and internal supports that are lightweight, require low maintenance, and are designed for years of dependable service. Our  FC Series Cooling towers  and  FT Series Cooling Towers   can withstand the harsh conditions of industrial...

VACUUM PUMP : Vacuum  is  space  devoid of  matter . The word stems from the Latin adjective  vacuus  for "vacant" or "void". An approximation to such vacuum is a region with a gaseous  pressure  much less than  atmospheric pressure . [1]  Physicists often discuss ideal test results that would occur in a  perfect  vacuum, which they sometimes simply call "vacuum" or  free space , and use the term  partial vacuum  to refer to an actual imperfect vacuum as one might have in a  laboratory  or in  space . In engineering and applied physics on the other hand, vacuum refers to any space in which the pressure is considerably lower than atmospheric pressure. [2]  The Latin term  in vacuo  is used to describe an object that is surrounded by a vacuum. The  quality  of a partial vacuum refers to how closely it approaches a perfect vacuum. Other things equal, lower gas ...

BOOSTER PUMP  :

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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COLOUR CODING FOR PROCESS LINES : Nitrogen -yellow vacuum- white water-green

Fish Bone Diagram or Ishikawa diagram (Cause and effect diagram) : Ishikawa diagrams were popularized in the 1960s by Kaoru Ishikawa, who pioneered quality management processes in the Kawasaki shipyards, and in the process became one of the founding fathers of modern management. The defect is shown as the fish’s head, facing to the right, with the causes extending to the left as fish bones the ribs branch off the backbone for major causes, with sub-branches for root-causes, to as many levels as required. Analysis of Fish Bone diagram: Man: Educational Qualification Experience Association with Company Workload 2. Machine: Qualification Preventive Maintenance Breakdown Calibrations 3. Measurement: Inprocess checks Release testing Control sample testing Stability testing 4. Material: Raw material (API& Excipients) Packing materials Semi finished Goods 5. Method: Dispensing Sifting 6. Environment: D...

Process Validation in Pharmaceuticals Manufacturing : What is Process Validation: Process validation is defined as the collection and evaluation of data from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process. Process validation activities categorized in three stages, such as Stage 1 as Process Design: The process is defined during this stage based on knowledge gained through development and scale-up activities such as lab scale / trial batches and optimization / pre – validation batches. Stage 2 as Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing with three consecutive validation batches. Stage 3 as Continued Process Verification: Ongoing as...