Seqens eBook - 9

ANALYTICAL

Ignoring the 10 questions. Ahead of developing a reliable method

regulatory review. The most effective analytical method development

for a product's intended use, many scientists fail to prepare a methods

assures that lab resources are optimized and that the methods developed

validation plan which asks the following key questions:

can be validated at each progressive step in the process. If changes to a
method are required, it's best to do so, and document the changes, before

1.

Is this method for the release of raw material?

2.

Is this method for in-process control?

3.

Is this method for final product release testing?

4.

What is the route of administration for this product?

5.

What is the maximum daily dose for this product?

6.

How long does the drug product's administration take?

7.

What are the crucial components that need to be monitored

backbone of the regulatory submission should be constantly optimized

for each sample of the product?

for increased yield and efficiency.

8.

What are the specifications?

CDMOs that undertake complex API or NCE development projects

9.

Does the compound have any genotoxic impurities?

10.

What is the impurity profile?

moving on to the next validation step.
Insufficient method optimization. Once initial studies look promising
for the product's intended use, method optimization should be
incorporated. Typical method optimization involves, for example,
improving method specificity, sensitivity, and studying solution
stability. A system suitability determination can also be made. As drug
development progresses the analytical methods that will form the

understand that no method should be considered routine given how
critically important time, cost and efficiency are to sponsors, yet it's
surprising how often these common mistakes occur. Analytical methods

Not thinking ahead to future methods testing. It's critical from the start to

that are scientifically sound, well understood and properly validated with

prepare for further review of all analytical methods developed. Ultimately

the regulatory pathway in mind are the basis for successful manufacturing

methods will undergo validation via peer review, then QA review, then

and regulatory approval, as well as safe and effective drugs.

Pharmaceutical Outsourcing |

9

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Seqens eBook

Table of Contents for the Digital Edition of Seqens eBook

Contents
Seqens eBook - 1
Seqens eBook - Contents
Seqens eBook - 3
Seqens eBook - 4
Seqens eBook - 5
Seqens eBook - 6
Seqens eBook - 7
Seqens eBook - 8
Seqens eBook - 9
Seqens eBook - 10
Seqens eBook - 11
Seqens eBook - 12
Seqens eBook - 13
Seqens eBook - 14
Seqens eBook - 15
Seqens eBook - 16
Seqens eBook - 17
Seqens eBook - 18
Seqens eBook - 19
Seqens eBook - 20
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