HOW TO DETERMINE QUALITY IMPACT ON THE PRODUCT

While determining the quality impact of any event identified in the manufacturing of an API, the below aspect shall be studied but not limited to

1. Does it affect the final application or use by the customer?
2. Does it affect the storage condition of the product?
3. Does it affect the packing of the product?
4. Does it affect the transportation of the product?
5. Does it affect the Human safety?
6. Does it affect the Critical control point?
7. Does it affect the stability of the product?

If yes to any of the above questionnaire than there is quality impact on the API product,
If No to all the above questionnaire than there is no quality impact on the API product.

In case there is a quality impact the disposition of the product is to be decided.

Readers may contact the author at anshuyadav.icgian@gmail.com.

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AUTHOR: ANSHU YADAV

quallpharmaconsultancy@gmail.com

anshuyadav.icgian@gmail.com