Drugs

Drugs 1600 Questions

0 Votes 1 Ans

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

1.15K viewsDrugs

0 Votes 1 Ans

How capa helps pharmaceutical industry, regards sunil wakhloo?

912 viewsDrugs

0 Votes 1 Ans

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

1.22K viewsDrugs Pharmaceutical

0 Votes 1 Ans

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

981 viewsDrugs Pharmaceutical

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

731 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.

910 viewsDrugs Pharmaceutical

0 Votes 1 Ans

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?

1.20K viewsDrugs Pharmaceutical

0 Votes 1 Ans

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?

948 viewsDrugs Pharmaceutical

0 Votes 1 Ans

Section 11, what do you test for labeling?

1.19K viewsDrugs Pharmaceutical

0 Votes 1 Ans

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.

1.10K viewsDrugs Pharmaceutical

0 Votes 1 Ans

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.”

1.16K viewsDrugs Pharmaceutical

0 Votes 1 Ans

Is it acceptable to blend second crop material with first crop material?

1.18K viewsDrugs Pharmaceutical

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Is mixing a centrifuge heel material with the next batch not blending? If we don’t consider that blending, how should that be handled?

1.15K viewsDrugs Pharmaceutical

0 Votes 1 Ans

Can heels from dryers, and the example that’s given here is 60 kilos, be left inside the equipment between batches of the same campaign?

893 viewsDrugs Pharmaceutical

0 Votes 1 Ans

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?

1.22K viewsDrugs Pharmaceutical

0 Votes 1 Ans

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?

1.19K viewsDrugs Pharmaceutical

0 Votes 1 Ans

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

1.20K viewsDrugs Pharmaceutical

0 Votes 1 Ans

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

1.13K viewsDrugs Pharmaceutical

0 Votes 1 Ans

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.

996 viewsDrugs Pharmaceutical

0 Votes 1 Ans

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?

1.26K viewsDrugs Pharmaceutical

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