Question: What is GMP?
Answer: 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.
Question: What is GDP?
Answer: Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of any document.
Question: Importance of Visual inspection?
Answer: Visual inspection is an essential operation in parenteral drug production to ensure the safety of the drug product in its container.
Question: Type of defects?
Answer: Critical, major minor.
Critical- crack, missing stopper, particles inside container.
Major- Sealing defects, broken container, volume variation.
Minor- stain on container, scratch on container, cosmetic.
Question: Where you perform visual inspection?
Answer: At visual inspection hood in visual inspection area
Question: How you measure light intensity of hood light source?
Answer: Using lux meter.
Question: What is lux ?
Answer: The lux (lx) is the SI unit of illuminance and luminous emittance, measuring luminous flux per unit area. It is equal to one lumen per square metre.
Question: what Lux range used in pharmaceuticals inspection?
Answer: 2000-3750 Lux
Question: what is deviation?
Answer: Departure from standard stablish procedure is known as deviation.
Question: What is Media?
Answer: Substance which promotes growth of microorganisms like bacteria, viruses, fungus.