PDA Technical Report No.65 Technology Transfer
https://www.pda.org/bookstore/product-detail/6680-tr-65-revised-technology-transfer
Non classé
ICH Q12 : TECHNICAL AND REGULATORY CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT
https://database.ich.org/sites/default/files/Q12_Annexes_Step4_2019_1119.pdf
ICH Q2(R1) : Validation of analytical procedures: Text and methodology
https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf
ICH Q8 : Pharmaceutical Development
https://database.ich.org/sites/default/files/Q8%28R2%29%20Guideline.pdf
ICH Q10 : Pharmaceutical Quality System
https://database.ich.org/sites/default/files/Q10%20Guideline.pdf
ICH Q5A(R1) : Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
https://database.ich.org/sites/default/files/Q5A%28R1%29%20Guideline_0.pdf
ICH Q5B : Analysis of the Expression Constructs in Cells Used for Production of r-DNA Derived Protein Products
https://database.ich.org/sites/default/files/Q5B%20Guideline.pdf
ICH Q3B(R2) : Impurities in New Drug Products
https://database.ich.org/sites/default/files/Q3B%28R2%29%20Guideline.pdf
ICH Q5A(R2) : Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
https://database.ich.org/sites/default/files/ICH_Q5A%28R2%29_Step2_draft_Guideline_2022_0826.pdf
ICH Q1A : Stability testing of new Drug Substances and products
https://database.ich.org/sites/default/files/Q1A%28R2%29%20Guideline.pdf