5. Describe the sequence of events for a raw material from the time it comes to

Question

5.     Describe the sequence of events for a raw material from the time it comes to the loading dock until it is used in the GMP manufacturing process.

7.     After a recent corporate audit, the production department that operates a bottle filling line for oral solid dosage forms received a report that revealed several noncompliances, including the following:

a.     All SOPs were in the control room, which is on a different floor.

b.     SOPs do not reflect differences in dosage, so supervisors gave verbal instructions for handling each dosage.

c.     Some instructions were written in permanent ink on the filling machine.

d.     An old version of an SOP was found in a drawer in packaging room.

Describe corrective actions required to resolve each of the observations.

9.     During the Annual Product Review for Vaccine XYZ, the team reviewed the data for over 50 fermentation and purification batches. The calculated Capability Index for %Purity after the chromatography step was 0.75. The team also identified that 10 different batches of chromatography resin were used and the Capability Index of the resin’s product capture parameter was 0.50. What should the team conclude about the chromatography step? List any recommendations.

10. The manufacturer of a popular biologic received a FDA Level I inspection four years ago. During that inspection, FDA checked the mandatory key systems plus two others: 1) Facilities and Equipment and 2) Packaging and Labeling. Two years ago, FDA conducted a Level II inspection and looked at the Quality System and the Materials system. Since FDA is due for another visit soon, employees want to prepare for another Level II inspection. Which key systems will FDA likely inspect? List at least 3 types of documents that they will likely want to observe. Also list at least 1 detail they will look for in EACH of those three types of documents.   

Explanation / Answer

Answer 5.

received by warehouse ----> sampled by quality control ----> labelled as under test ----> results meets acceptance criteria ----> labelled as approved ----> can be used for manufacturing

Answer 7.

a. SOPs should be moved to respective manufacturing rooms , whichever applicable.

b. SOPs to be revised to include the difference in doses

c. Instructions to be erased from filling machine and shall be written in SOP . Training on new SOP to be provided to relevant personnel

d. deviation to be logged for not following document control system. Also, review of document control system need to be carried out and identified gaps to be corrected

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