API production and quality assurance interview questions

  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...