Is Annex 2 Applicable To The Manufacture Of Apis Used In Biological M

1.	Is Annex 2 Applicable To The Manufacture Of Apis Used In Biological Medicinal Products?
Answer» Yes. The manufacture of APIs for biological MEDICINAL products for HUMAN USE is usually performed in immediate conjunction with the manufacture of the biological medicinal product itself. For that reason, Annex 2 is written to cover both the API and the finished product manufacturing steps of biologicals. Additionally, PART II of the CODE is applicable to the manufacture of APIs for biological medicinal products. Yes. The manufacture of APIs for biological medicinal products for human use is usually performed in immediate conjunction with the manufacture of the biological medicinal product itself. For that reason, Annex 2 is written to cover both the API and the finished product manufacturing steps of biologicals. Additionally, Part II of the Code is applicable to the manufacture of APIs for biological medicinal products.

Is Annex 2 Applicable To The Manufacture Of Apis Used In Biological Medicinal Products?

Answer»

Yes. The manufacture of APIs for biological MEDICINAL products for HUMAN USE is usually performed in immediate conjunction with the manufacture of the biological medicinal product itself. For that reason, Annex 2 is written to cover both the API and the finished product manufacturing steps of biologicals. Additionally, PART II of the CODE is applicable to the manufacture of APIs for biological medicinal products.

Yes. The manufacture of APIs for biological medicinal products for human use is usually performed in immediate conjunction with the manufacture of the biological medicinal product itself. For that reason, Annex 2 is written to cover both the API and the finished product manufacturing steps of biologicals. Additionally, Part II of the Code is applicable to the manufacture of APIs for biological medicinal products.

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