Reference no: EM133277933

Assignment:

GMP Complaince

1. Which of the following is true:

• The FDA does not care how well you staff your facility as long as you can keep up with market demand
• A college degree is required to work in a GMP environment
• The GMPs prohibit ill employees or employees with open lesions from working in the manufacturing areas
• There is no requirement to keep a record of the consultants you use for advice

2. Which of the following is not a generally acceptable mechanism for interpreting regulations?

• Read the section of the preamble that pertains to the regulation you are researching
• Search the FDA's database to determine how the regulation is applied to warning letters
• Read linkedin diatribes from individuals with whom you are not familiar, but whom claim to be experts on the regulations
• Read guidance documents that discuss the topic covered in the regulation you are researching

3. Which of the following is a true statement?

• It is difficult to measure how effective the GMP regulation is, since we don't really have any negative controls to measure it against
• Only a company can get in trouble for violating GMPs and the applicable Acts. Individual people cannot be prosecuted.
• If you make a mistake when manufacturing a batch, you may still be able to release the batch as long as you investigate the issue and determine the impact is negligible.
• If you make a mistake when manufacturing a batch, you cannot release that batch under any circumstances because that batch is now adulterated.

4. How did the FDA first become aware of the rampant falsification at Rambaxy?

• Their best investigators performed an inspection and discovered the falsified data
• Some of the reviewers noticed an aberration in the data submitted in one of the ANDAs, and this led to the investigation that uncovered the falsification
• A whistleblower from within the company contacted the FDA multiple times, and finally received a response
• Patients and doctors complained that the generic drugs were not working as well as the branded ones, and the FDA took the complaints seriously and launched an investigation that resulted in the findings of falsified studies

5. What did the Board of Directors do when Dinesh Thaker informed them of the systemic falsification going on at Rambaxy?

• They thanked him, acted appropriately surprised, and later had him fired
• They did not seem surprised and asked him if anyone else knew about his findings, then planted evidence on his computer to have him fired
• They immediately began contacting health authorities and remediating the issues
• They implemented a plan in which they would send all the sub-par medicine to markets other than the US to avoid trouble with the FDA