New api supplier

Quality Control
1

Greetings from Greece ,
Which analytical procedures have to be performed as the API supplier is going to change?
For the final product , is it necessary to performed a full validation ?
What analytical procedures have to be performed?

Thank you in advance
Sofia

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2

In case of a change in the supplier (Manufacturer) of API, it is necessary to consider following aspects,

  • To analyze the samples from at least three batches of API as per specification (complete analysis including impurities profile). If route of synthesis of the new supplier of API is different than the current supplier then impurities may change.
  • To perform Process validation on three consecutive batches of the final drug product using API from the new supplier.
  • To keep the samples of the final drug product (of process validation batches) on stability studies and evaluate the results.
  • It is necessary to perform a full process validation.
  • It is necessary to perform vendor qualification and approval (of the new supplier/manufacturer).
  • To inform regulatory authorities through the product dossier periodical updates about change in the vendor of API.
  • The above procedure to be executed through internal SOP on the Change Control Management.
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3

Thank you very much for your response.
Regarding the analytical method validation of the final product?
Is it necessary to perform a full validation ( linearity, accuracy, loq, lod , robustness or even forced degradation studies)?

4

Re-validation of analytical method is not required if the API purchased from a different vendor (manufacturer) has the same specification and route of synthesis as that of the initial vendor to ensure that there are no changes in the quality parameters including impurity profile.

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