Process validation

Quality Assurance
1

For process validation 3 different batches of starting materials is required from same vendor to perform validation.

2

Yes, 3 different batches required during vendor qualification in R&D as well as in productionā€¦

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3

Hi, thank you, i agree with you 3 different batches for VQ qualifications, can you tell me the guidelines I tried not found 3 different batches for validation.

4

In fact this is also stability study data submission requirement as per ICH Guidelines.
Please refer ICH Q1A (R2) February 2003 guidelines of STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS

It sates following requirement,
2.2.3. Selection of Batches
Data from stability studies should be provided on at least three primary batches of the drug product. The primary batches should be of the same formulation and packaged in the same container closure system as proposed for marketing. The manufacturing process used for primary batches should simulate that to be applied to production batches and should provide product of the same quality and meeting the same specification as that intended for marketing. Two of the three batches should be at least pilot scale batches and the third one can be smaller, if justified. Where possible, batches of the drug product should be manufactured by using different
batches of the drug substance.
Stability studies should be performed on each individual strength and container size of the drug product unless bracketing or matrixing is applied.

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5

Types of process validation

Prospective Validation
Retrospective Validation
Concurrent Validation
Revalidation

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6

if we are using two different sources of API use in Process validation is right or wrong

7

There are two casesā€¦
1.if you want to quality a new vendor then 3 different batches shall be procure from same vendor and proceed for validation.
2. If there are any changes in product manufacturing process, validation shall be carried out. In this case you can use different sources of API, as those vendors are already qualifiedā€¦

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8

thank you so much

9

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