FDA

Question 1

0 Votes 1 Ans

Is Haccp mandatory?

9 viewsadmin Changed status to publish February 17, 2021FDA Food Safety

Question 2

0 Votes 1 Ans

What is FDA’s focus while conducting a routine surveillance inspection?

32 viewsadmin Changed status to publish February 11, 2021FDA

Question 3

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Is there a distinction between a significant and a critical step? Q7A does not define “significant”?

37 viewsadmin Changed status to publish February 11, 2021FDA

Question 4

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Please expand on what is acceptable as true copies. Do you mean actual reproductions in place of originals, scanned records, or validated computer system accepted by the FDA?

16 viewsadmin Changed status to publish February 11, 2021FDA

Question 5

0 Votes 1 Ans

When making corrections to documented entries, the only requirements are to sign, date, and leave original entry readable. Was there any discussion when writing Q7A to also record the reason for the change? Will field investigators expect this?

15 viewsadmin Changed status to publish February 11, 2021FDA

Question 6

0 Votes 1 Ans

Revalidation of computerized systems. What is required for computerized materials management systems used to monitor receipts, sampling testing or release of materials?

30 viewsadmin Changed status to publish February 11, 2021FDA

Question 7

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Regarding computer validation, is it necessary to second check all data into the computer system or only the critical data?

20 viewsadmin Changed status to publish February 11, 2021FDA

Question 8

0 Votes 1 Ans

To what extent are computer programs to be documented as SOPS?

34 viewsadmin Changed status to publish February 11, 2021FDA

Question 9

0 Votes 1 Ans

What amount of detail should be included in the standard operating procedures (SOPs)?

24 viewsadmin Changed status to publish February 11, 2021FDA

Question 10

0 Votes 1 Ans

Will a laboratory subsequently be notified of GLP deviations not listed on the FDA-483?

23 viewsadmin Changed status to publish February 11, 2021FDA

Question 11

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Is it possible to obtain an exemption from specific provisions of the GLPs for special nonclinical laboratory studies?

31 viewsadmin Changed status to publish February 11, 2021FDA

Question 12

0 Votes 1 Ans

How can consumers identify products that may be violative?

23 viewsadmin Changed status to publish February 11, 2021FDA

Question 13

0 Votes 1 Ans

What if the improper storage conditions include exposure to toxic fumes or radiation?

37 viewsadmin Changed status to publish February 11, 2021FDA

Question 14

0 Votes 1 Ans

How does the FDA interpret the regulations (21 CFR Part 211) regarding the establishment of expiry dating for chemicals, reagents, solutions, and solvents?

17 viewsadmin Changed status to publish February 11, 2021FDA

Question 15

0 Votes 1 Ans

How do the Part 11 regulations and “predicate rule requirements” (in 21 CFR Part 211) apply to the electronic records created by computerized laboratory systems and the associated printed chromatograms that are used in drug manufacturing and testing?

37 viewsadmin Changed status to publish February 9, 2021FDA

Question 16

0 Votes 1 Ans

Does FDA expect firms to investigate both released and rejected lots for potential recalls?

44 viewsadmin Changed status to publish February 9, 2021FDA

Question 17

0 Votes 1 Ans

What does an FDA investigator do upon completing an inspection?

28 viewsadmin Changed status to publish February 9, 2021FDA

Question 18

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Does FDA prefer one type of material over another (e.g., polyvinylidene difluoride over stainless steel) for construction of recirculating loops in water for injection (WFI) systems?

39 viewsadmin Changed status to publish February 9, 2021FDA

Question 19

0 Votes 1 Ans

Is there a list of CDER-approved drug manufacturing equipment?

35 viewsadmin Changed status to publish February 9, 2021FDA

Question 20

0 Votes 1 Ans

Will the ConOps help address problems at manufacturing facilities that have impacted approval of drug applications?

22 viewsadmin Changed status to publish February 9, 2021FDA

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