API production and quality assurance interview questions

1.Monitor daily operations and ensure production efficiency and productivity. 2.Preparation of validation protocols and validation reports  3.Preparation of batch manufacturing reports and batch cleaning records. 4.Batch creation and raw material request in ERP and purchase order requisition in ERP. 5.

  To cut to the point, the difference between GMP and cGMP is that GMP requires manufacturers to ensure that their products are safe and effective. cGMP requires manufactures to employ technologies and systems that are up to date and comply with GMP regulations. Why GMP is known as cGMP? GMP is also sometimes referred to as "cGMP".  The "c" stands for "current," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation . Why C is small in cGMP? 1 Answer. “c” should be written in small letters as  it is dynamic and it changes . This is from another site: GMP is also sometimes referred to as “cGMP”. The “c” stands for “current,” reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation.

 solvents boiling points : Solvent Boiling Point (°C) Solvent Boiling Point (°C) Acetic Acid 118.0 Ethyl Acetate 77.1 Acetic Acid Anhydride 139.0 Ethyl Ether 34.6 Acetone 56.3 Ethylene Dichloride 83.5 Acetonitrile 81.6 Ethylene Glycol 197.5 Benzene 80.1 Heptane 98.4 iso-Butanol 107.7 n-Hexane 68.7 n-Butanol 117.7 Hydrochloric Acid 84.8 tert-Butanol 82.5 Methanol 64.7 Carbon Tetrachloride 76.5 Methylene Chloride 39.8 Chlorobenzene 131.7 MTBE 55.2 Chloroform 61.2 Pentane 36.1 Cyclohexane 80.7 Petroleum Ether 35.0-60.0 Cyclopentane 49.3 iso-Propanol 82.3 Dichloromethane 39.8 n-Propanol 97.2 Diethyl Ether 34.6 Pyridine 115.3 Dimethyl Acetamide 166.1 Tetrahydrofuran 66.0 Dimethyl Formamide 153.0 Toluene 110.6 Dimethyl Sulfoxide 189.0 Trifluoroacetic Acid 71.8 Dioxane 101.0 Water 100.0 Ethanol 78.3 Xylene 140.0

  The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government.. Title 21 of the CFR is  reserved for rules of the Food and Drug Administration . What is the purpose of 21 CFR Part 11 21 CFR Part 11 is the FDA's regulations for electronic documentation and electronic signatures. It  outlines the administration of electronic records in a medical device company's quality management system .

  The ALCOA Principles ALCOA is an acronym for the original five principles of data integrity. Those principles are: Attributable Legible Contemporaneous Original Accurate However, the original ALCOA principles have since been updated to ALCOA+. The original principles remain with four additions: Complete Consistent Enduring Available

  Centrifugation  uses gravity and centrifugal force to separate particles heavier than the liquid medium . Centrifuges spin the material at high rotation speeds and separate the particulate from the liquid.

  Agitated nutsche filter and drying (ANFD) : Agitated Nutsche Filter with drying is a closed vessel special designed to  separate solid and liquid by filtration under pressure or vacuum . The ANFD closed system ensures odorless contamination free & non-polluting working condition maintaining products purity as well hygiene.

Contaminants: Contaminants are any impurity, Product, or substance other than product manufacturing. Foreign products, Particulate matter, Microorganisms,  Endotoxin  (degrade microorganisms), Cross-contamination is a case of contamination. The Peoples generated contaminant: Our outer skin is completely shed every 24 hours. Particles of 0.3micron and greater are liberated at a rate varying between 100000 to 10 million per minute. A person walking will liberate thousands of bacteria per minute, and a single sneeze can be produced up to 1 million bacterias. The manufacturing process itself can generate, for example, paint off from equipment, dust from belt drives, etc. Contamination: “The undesired introduction of the chemicals or a microbial nature, or of foreign matter into or on to a starting material or intermediate, during production, sampling, packaging or repackaging, storage, and transport.” Types of contamination: Chemical contamination (leftover residue of the previous...

  1. Working as production crystallization area total in charge working under 4 members per shift. 2. Effective utilization of manpower in the plant. 3.  Ensure production as per cGMP and GDP in the plant. 4. Monitoring critical process parameters in the plant. (Temp, vacuum, RPM). 5.  Monitoring and controlling the yield losses during the production process. 6. Reduce the cost reduction in the plant. 7. Reduce the time cycle of the product. 8. Following the 5s in the plant. 9. Implementation of six sigma and kaizen in the plant. 10. Raising the near miss in the portal and completing the work. 11. Batch creation and raw material request ERP and indent the raw materials. 12. Maintain the online documentation. 13. Planning and scheduling preventive maintenance as the requirement 14. Coordinate with maintenance for any breakdowns and maintenance work. 15. Taking hot work permits, height work permits, and confined space entry from the safety departme...

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...