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  :