Drugs

Question 1

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What is the difference between retest date and expiration date for drug substances?

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Question 2

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How capa helps pharmaceutical industry, regards sunil wakhloo?

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Question 3

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

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Question 4

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

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Question 5

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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.”

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Question 6

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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.

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Question 7

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Section 11, what do you test for labeling?

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Question 8

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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?

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Question 9

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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?

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Question 10

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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.

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Question 11

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

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Question 12

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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?

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Question 13

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

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Question 14

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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?

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Question 15

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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?

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Question 16

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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?

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Question 17

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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?

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Question 18

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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.

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Question 19

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

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Question 20

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

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