Pharmaceutical

Pharmaceutical 1645 Questions

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How often is sanitization of typically recommended? Weekly, monthly, quarterly?

1.58K viewsPharmaceutical

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If the WFI distribution system circulates at 85 degrees C , is sanitization required?

1.66K viewsPharmaceutical

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Do you recommend any special strategy for evaluating increasing the interval between routine sanitization for a system that has been operating without issues?

1.61K viewsPharmaceutical

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Pharmaceutical water System Biofilm-Growth through Penetration – How quickly can 0.2 micron filters suffer from growth through penetration (what is a good replacement interval to start with?)

1.63K viewsPharmaceutical

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Is there an ideal or recommended number of POU drops that are included in a distribution loop?

1.63K viewsPharmaceutical

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Do you recommend daily flushing of POU drops that are not routinely used?

1.44K viewsPharmaceutical

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When doing microbial counts, is using negative controls that succeed proof enough that testing is not the issue?

1.48K viewsPharmaceutical

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

1.29K viewsDrugs Pharmaceutical

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

1.28K viewsDrugs 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.”

337 viewsDrugs 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.

399 viewsDrugs Pharmaceutical

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Section 11, what do you test for labeling?

395 viewsDrugs 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?

373 viewsDrugs 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?

337 viewsDrugs 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.

325 viewsDrugs Pharmaceutical

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

297 viewsDrugs 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?

344 viewsDrugs Pharmaceutical

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

350 viewsDrugs 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?

358 viewsDrugs 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?

346 viewsDrugs Pharmaceutical

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