Approprlate controls shall be exerclsed over computer or related systems to assu

Question

Approprlate controls shall be exerclsed over computer or related systems to assure that changes in master production and control records are instituted only by 33. a. r Fede b. the backup file of data lsaccurate c. appropriate validation records ace maintained d. all of the above ts UFACT 34. Electronic equipment (such as the checkweighen) must be calibrated, inspected or checked: a. every & months b. routinely 35. Fiber-releasing filters may not be used in any phase of the manufacturing operation of a parenteral drug product Dl ING a. True b. False e peactie 6. Asbestos filters are to be used in non-sterile fatrations only. a. True b. False 37. Components, drug product containers and closures may be stored directly on the floor provided there is a concrete sub flooring 60t. a. True b. False 38. Code numbers must be assigned to each lot of components but not to containers or closures a. True b. False Only drug product components, not containers, or closures, must be examined or tested and approved by Quaity Control before use. 39. ug a. True b. False 40. Untested components, drug product containers, and dlosures shall be stored under upon receipt. 41. Materials delivered to packaging can be used under certain circumstances, pending approval and release by Quality Control. a. True b. False 42. Only two samples from each lot of components, containers, and closures need be collected for appropriate testing by Quality Control. a. True b. False 43. If it is necessary to sample components from the top, middle, and bottom of its container, the sample should be composited a. True b. False

Explanation / Answer

3. A) changes in master production and control records are instituted only by authorised personnel

This is a part of the federal regulations title, which is involved in goof practice of manufacturing for the pharmaceuticals that have been finished. The control should only be done by the personnel who are is required that the different systems require to be checked on a constant basis so that there would be proper maintenance of accuracy.

Related Questions

Navigate

• Browse (All)
• Browse A
• Subjects

---

---

Integrity-first tutoring: explanations and feedback only — we do not complete graded work. Learn more.