Drugs

Drugs 1600 Questions

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Are you familiar with reports on aspergilli in hospital water systems? Any pertinence to Purified Water systems for pharma?

965 viewsadmin Changed status to publish February 19, 2021Drugs Pharmaceutical

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What degree of validation should be necessary when data is recorded on a computer and a second system?

929 viewsadmin Changed status to publish February 15, 2021Drugs Pharmaceutical

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Can you perform accelerated stability studies on an API to extend the retest date if running room temperature studies concurrently? And, the statement is made, “Drug product firms do this routinely, to place a two-year expiry date on the product.”

17 viewsadmin Changed status to publish February 9, 2021Drugs Pharmaceutical

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With regard to packaging materials, Q7A does not make a distinction between inner and outer containers. If you have written procedures for the inner containers that actually come into contact with the API, do you also need written procedures for the outer containers, such as fiberboard boxes that do not actually contact the API? An example of the inner container might be glass jar or vial.

36 viewsadmin Changed status to publish February 9, 2021Drugs Pharmaceutical

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Section 11, what do you test for labeling?

22 viewsadmin Changed status to publish February 9, 2021Drugs Pharmaceutical

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A packaging/labeling question; transport of API outside the facility, can boxes containing API be sealed with tamper-evident tape, or must the inner bottle or container be sealed?

28 viewsadmin Changed status to publish February 9, 2021Drugs Pharmaceutical

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What kind of ID test is acceptable for packaging materials, such as polyethylene bags, lined drums? Is the shipping document of packaged material used in lieu of a C-of-A?

16 viewsadmin Changed status to publish February 9, 2021Drugs Pharmaceutical

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9.2 states that containers should not be additive beyond the specified limits. This imputes the need to evaluate packaging for interaction with the API. On the other hand, that additive of packaging implied is not a concern so long as the API is not altered beyond its specification. Please clarify how an API manufacturer might justify not evaluation product/packaging interactions.

23 viewsadmin Changed status to publish February 9, 2021Drugs Pharmaceutical

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Does the FDA have any objection to storage and shipment of APIs in polyethylene lined fiber drums?

13 viewsadmin Changed status to publish February 9, 2021Drugs Pharmaceutical

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What’s the minimum amount of information required for the labels on containers of starting materials when they are received prior to API manufacturing?

28 viewsadmin Changed status to publish February 9, 2021Drugs Pharmaceutical

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Under what conditions can quality typically delegate authority for releasing Intermediates to production?

25 viewsadmin Changed status to publish February 9, 2021Drugs Pharmaceutical

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“All agree for closed system environmental monitoring room classifications are not necessary. What about where a finished API is isolated and packaged?

34 viewsadmin Changed status to publish February 9, 2021Drugs Pharmaceutical

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Would the agency expect a maximum residual carry over from a previous batch to be specified and validated? What other rationale could be used for demonstrating that residual carryover does not affect final API quality?

19 viewsadmin Changed status to publish February 9, 2021Drugs Pharmaceutical

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The section on impurities relates only to process-related impurities. Does Q7A address impurities that arise from contaminants external to the process, for example, brine inclusion into a batch from a condenser failure? If not, where is this addressed?

9 viewsadmin Changed status to publish February 9, 2021Drugs Pharmaceutical

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This one applies to chromatography fractions and if your specification is 90 to 100% for the potency, is mixing of fractions with a potency less than 90% allowed if the final potency of the blended fraction meets the not less than 90% purity requirement?

20 viewsadmin Changed status to publish February 9, 2021Drugs Pharmaceutical

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Is mixing of two or more batches of intermediate allowed, one of which might be OOS, into solution when reacting the next stage? Assume a weighted average meets the specification.

25 viewsadmin Changed status to publish February 9, 2021Drugs Pharmaceutical

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Do you need to perform homogeneity tests on two acceptable batches that have been blended into one batch?

26 viewsadmin Changed status to publish February 9, 2021Drugs Pharmaceutical

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Is it only required for critical steps to be witnessed or should all steps be witnessed?

41 viewsadmin Changed status to publish February 9, 2021Drugs Pharmaceutical

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Section 8.4 says that batches should have been tested prior to blending. Do you strongly recommend doing it prior to or is it possible for the company to take a business risk and test individual batches at the same time that blending operation is taking place?

17 viewsadmin Changed status to publish February 9, 2021Drugs Pharmaceutical

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If you blend a tailing into another batch and then retest the blended batch, if you have a policy that is based on retest dates given after the testing, then wouldn’t the blended batch get a retest clock in this case?

27 viewsadmin Changed status to publish February 9, 2021Drugs Pharmaceutical

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